About The Role

As a Senior Software Engineer, Android on the Roku Mobile App team, you will help shape the future of how millions of users interact with their Roku Streaming Devices. You’ll work on building intuitive, reliable, and highly performant Android experiences that allow customers to monitor and control Roku streaming devices from TVs to Players and beyond.

This role offers the opportunity to work across a modern, evolving tech stack including Kotlin, Compose, and Googles’s latest frameworks. You’ll collaborate closely with design, product, and cross-functional engineering teams to bring innovative features to life, improve performance, and make every day smart home interactions seamless.

You should be motivated by curiosity and initiative, eager to take ownership of features and run with them, while remaining grounded in a team-first, collaborative mindset.

About The Team

You will be joining a talented, high-performance team with a history of delivery. We are looking for someone who can help us keep up this pace and continue delivering high-quality app as we grow.

With so many people using our products globally, we’ve become well-known for products that “just work” right out of the box and integrate almost by magic. That doesn’t happen by accident, which is why we are committed to making sure our products aren’t just intuitive, they’re obvious

What You’ll Be Doing

• Design and build advanced applications and features for the Android platform
• Integrate with cloud APIs and local device communication protocols to control smart devices
• Write and maintain tests using frameworks such as JUnit and Espresso
• Collaborate with cross-functional teams to define, design, and ship new features for mobile devices, optimizing for touch experiences. Write well-designed, testable, and efficient code
• Debug, profile, and optimize app performance across a range of Android devices
• Participate in design and code reviews, helping elevate code quality across the team
• Stay up to date with Android platform capabilities, tools, and libraries, and propose how we can leverage them
• Contribute to roadmap planning, technical design, and release delivery

We’re Excited If You Have

• Professional Android development experience, ideally with Kotlin and/or Compose
• Strong experience shipping and maintaining production apps in the Play Store
• Proficiency in using AI tools (e.g., GitHub Copilot, ChatGPT) and experience with prompt engineering
• Experience working with IoT or networked device interactions is a big plus
• Familiarity with BLE, webs sockets, or MQTT protocols is a bonus
• Experience collaborating with cross-functional teams in agile environments
• Proficient in the Android development toolset
• Strong understanding of Android architecture, UI/UX patterns, and app lifecycle
• Excellent communication and debugging skills
• Bachelor’s or Master’s/PHD in Computer Science or related technical field, or relevant professional experience. 

#LI-AM3

About the team

You will be part of the Roku Video Platform Engineering team and responsible for building the next-generation video services for the Roku Cloud TV Platform. Roku pioneered TV streaming and continues to innovate and lead the industry. The Roku Channel has us well-positioned to help shape the future of streaming. Continued success relies on investing in the Roku Cloud TV Platform to deliver a high-quality streaming TV experience on a global scale. 

About the role

As a Video Encoding Engineer, you will build, optimize, and maintain high-performance video processing workflows. You will own our end-to-end encoding toolchain—from experimentation and profile tuning to automated packaging workflows—ensuring our content is delivered with maximum quality, reliability, and efficiency.

You will work closely with the team on key video services projects around video ingestion, encoding, VoD/live-linear, Server-Side Ads Insertion, and Video QoS, with the goal of delivering a best-in-class streaming TV experience across all Roku devices. The projects that you will work on will impact millions of Roku users around the world. Throughout, you will have the opportunity to collaborate with key product engineering stakeholders across Roku engineering teams and to lead the design of our video services platform.

The ideal candidate will have endless curiosity and can pair a global mindset with locally relevant execution. You should be a gritty problem solver and self-starter who can drive programs with the product and commercial teams within Roku and across external strategic partner organizations. The successful candidate will display a balance of hard and soft skills, including the ability to respond quickly to changing business needs. 

What you’ll be doing

• Design, build, optimize, and maintain FFmpeg-based encoding pipelines for both VOD and Live workflows, operating at scale in cloud environments such as AWS or GCP
• Develop, refine, and validate encoding presets for modern codecs, including H.264, HEVC, and AV1, ensuring optimal quality-to-bitrate performance
• Implement advanced encoding strategies such as multi-pass workflows, CRF tuning, per-title optimizations, and quality-targeted encoding
• Benchmark and evaluate video quality using VMAF and other objective metrics to drive continuous improvements in efficiency and viewing experience
• Build and maintain adaptive streaming packaging workflows, including HLS, DASH, and CMAF, ensuring broad device compatibility and reliable playback
• Profile and optimize system performance by identifying and eliminating bottlenecks across compute, storage, and I/O layers
• Write, review, and improve code, assessing architectural tradeoffs to deliver secure, high-performance, and highly concurrent video infrastructure services
• Collaborate cross-functionally with engineering, product, and platform teams to support and advance company-wide video service initiatives

We’re excited if you have

• Strong problem-solving and analytical abilities
• 5+ years of solid programming experience and passionate about writing high-quality and well-architected code
• Expert-level knowledge of FFmpeg or Gstreamer and their related toolchains (filters, flags, debugging, custom builds)
• Experience with hardware-based encoder/decoder libraries (NVENC, Vulkan
• Strong understanding of compression theory, codec internals, GOP structures, bitrate control, etc
• Experience with container formats: MP4, TS, fragmented MP4, ISOBMFF
• Familiarity with HLS/DASH, CMAF, adaptive bitrate design, DRM, and SCTE 35
• A track record working with applied AI-based video enhancement and compression algorithms (Super Resolution, Denoising, Artifact Removal)
• Hands-on experience with cloud compute (AWS Lambda/ECS/Batch, GCP, Kubernetes, or similar)
• Ability to handle periodic on-call duty as well as out-of-band requests; strong written and verbal communication skills
• Bachelor's degree in computer science plus 8 years of experience or equivalent; Master's degree preferred 

#LI-SB-5

About the Role

You will be a SME and technical leader in engineering Infrastructure, productivity and enterprise tooling, partnering with globally distributed Engineering, Product and Security teams and systems.

What You’ll Be Doing

Roku is seeking a world class engineer to be a true force multiplier by owning the strategy, architecture, and long-term execution of engineering infrastructure, enterprise tooling, and AI-assisted workflow automation. This architect/strategist role drives org-wide improvements in engineering productivity, delivery throughput, quality, security posture, and cost efficiency by building platforms, working practices and automation (including AI/LLM-enabled capabilities) that scale across geographies and time zones.

Key Responsibilities

AI-First Automation & Intelligent Tooling

• Define and lead an AI-first automation roadmap for Engineering Infrastructure and Enterprise Tooling (e.g., reducing waste, accelerating reviews, improving incident response, increasing release confidence).
• Architect and ship AI/LLM-enabled workflow automation across the SDLC (e.g. risk assessment, automated build, test and deployment, intelligent test selection, change-impact analysis, auto-triage of build/test failures).
• Establish policies and guardrails for AI usage in internal tools: data handling, prompt/response logging, model/provider selection, evaluation, fallback behaviors, and abuse prevention.

Dev Productivity & Enterprise Tooling (Global Scale)

• Set technical direction and standards for the globally used developer tools, including build systems. Source code management, branching/release strategy, and self-service support tools.
• Architect and evolve, CI/CD and build/test pipelines using Jenkins, Docker, and build systems (Bazel /BitBake/Yocto  preferred) to support multi-site engineering environments.
• Own and scale test and quality workflows leveraging test management systems (e.g., TestRail or equivalent), enabling consistent traceability, reporting, and release sign-off across distributed teams.
• Drive Jira workflow design and automation (templates, guardrails, integrations) to provide consistent cross-org visibility and execution.

Workflow Automation (Cross-Functional, Cross-Geo)

• Design and implement automation spanning Engineering, Product, Marketing, and Partners (e.g., launch readiness, certification/release checklists, partner onboarding, incident/change workflows).
• Replace manual coordination with durable automation and integrations that work reliably across regions/time zones.

Security, Cost, Performance, and Reliability (Distributed Systems)

• Embed secure-by-default controls into pipelines and tooling (access control, secrets handling, audit trails, policy enforcement), including for AI-enabled systems.
• Improve build/test performance and reliability (build times, test duration, flake reduction, pipeline stability) using measurable KPIs and operational rigor.
• Drive cost efficiencies across tooling/infrastructure (compute utilization, caching strategies, license rationalization including AI/runtime costs and ROI tracking.
• This is a highly visible role and you will report directly to a Vice President of Engineering. This requires a very strong technical leader with experience in the development of consumer electronics devices. The right person for this role will have ability to collaborate well with engineering and partner teams.
• Own cross-team architectures and standards; drive adoption through influence, clear technical judgment, and sustained multi-quarter execution.
• Lead design reviews, mentor senior engineers, and unblock the hardest technical problems across distributed teams and systems.
• Provide long-term stewardship via roadmaps, operational maturity (runbooks/SLOs), and incident/postmortem practices suitable for 24/7 global operations.
• Establish yourself as the person others bring their hardest problems to

We’re Excited If You Have

• Bachelor’s in Computer Science or Computer Engineering, or equivalent experience
• Prior experience at Staff, Principal, or Architect level
• Ownership in platform/infrastructure, developer productivity, CI/CD, build systems, or workflow automation, including work spanning globally distributed teams and systems.
• Strong, hands-on knowledge of:

• • Git (workflows, branching strategies, release management)
  • Jenkins (CI/CD pipeline design, scaling, reliability)
  • Docker containers (reproducible build/test execution)

Build systems ( itBake/Yocto preferred)

• Jira (workflow design/automation, cross-team visibility)
• Test management systems (e.g., TestRail or equivalent)
• Demonstrated experience delivering automation at scale, including building platforms/components used by multiple teams.
• Strong systems thinking across security, reliability, performance, and cost tradeoffs.
• Excellent written communication (architecture docs, decision records, operating procedures).
• Experience building AI-assisted developer tooling (e.g., CI insights, test intelligence, code review automation, release risk scoring, incident copilots).
• Experience implementing evaluation/monitoring for AI systems (quality metrics, drift, offline test sets, human feedback loops).
• Extensive experience with software development on embedded Linux,  multi-process architectures and IPC mechanisms
• Experience working in large cross functional teams and ability to influence teams that don't report to you
• Ability to see the big picture while focused on short-term objectives and deliverables
• Ability to multi-task and drive parallel projects and distributed teams with tight deadlines

#LI-NM1

About the Role

You will be a SME and technical leader in engineering Infrastructure, productivity and enterprise tooling, partnering with globally distributed Engineering, Product and Security teams and systems.

What You’ll Be Doing

Roku is seeking a world class engineer to be a true force multiplier by owning the strategy, architecture, and long-term execution of engineering infrastructure, enterprise tooling, and AI-assisted workflow automation. This architect/strategist role drives org-wide improvements in engineering productivity, delivery throughput, quality, security posture, and cost efficiency by building platforms, working practices and automation (including AI/LLM-enabled capabilities) that scale across geographies and time zones.

Key Responsibilities

AI-First Automation & Intelligent Tooling

• Define and lead an AI-first automation roadmap for Engineering Infrastructure and Enterprise Tooling (e.g., reducing waste, accelerating reviews, improving incident response, increasing release confidence).
• Architect and ship AI/LLM-enabled workflow automation across the SDLC (e.g. risk assessment, automated build, test and deployment, intelligent test selection, change-impact analysis, auto-triage of build/test failures).
• Establish policies and guardrails for AI usage in internal tools: data handling, prompt/response logging, model/provider selection, evaluation, fallback behaviors, and abuse prevention.

Dev Productivity & Enterprise Tooling (Global Scale)

• Set technical direction and standards for the globally used developer tools, including build systems. Source code management, branching/release strategy, and self-service support tools.
• Architect and evolve, CI/CD and build/test pipelines using Jenkins, Docker, and build systems (Bazel /BitBake/Yocto  preferred) to support multi-site engineering environments.
• Own and scale test and quality workflows leveraging test management systems (e.g., TestRail or equivalent), enabling consistent traceability, reporting, and release sign-off across distributed teams.
• Drive Jira workflow design and automation (templates, guardrails, integrations) to provide consistent cross-org visibility and execution.

Workflow Automation (Cross-Functional, Cross-Geo)

• Design and implement automation spanning Engineering, Product, Marketing, and Partners (e.g., launch readiness, certification/release checklists, partner onboarding, incident/change workflows).
• Replace manual coordination with durable automation and integrations that work reliably across regions/time zones.

Security, Cost, Performance, and Reliability (Distributed Systems)

• Embed secure-by-default controls into pipelines and tooling (access control, secrets handling, audit trails, policy enforcement), including for AI-enabled systems.
• Improve build/test performance and reliability (build times, test duration, flake reduction, pipeline stability) using measurable KPIs and operational rigor.
• Drive cost efficiencies across tooling/infrastructure (compute utilization, caching strategies, license rationalization including AI/runtime costs and ROI tracking.
• This is a highly visible role and you will report directly to a Vice President of Engineering. This requires a very strong technical leader with experience in the development of consumer electronics devices. The right person for this role will have ability to collaborate well with engineering and partner teams.
• Own cross-team architectures and standards; drive adoption through influence, clear technical judgment, and sustained multi-quarter execution.
• Lead design reviews, mentor senior engineers, and unblock the hardest technical problems across distributed teams and systems.
• Provide long-term stewardship via roadmaps, operational maturity (runbooks/SLOs), and incident/postmortem practices suitable for 24/7 global operations.
• Establish yourself as the person others bring their hardest problems to

We’re Excited If You Have

• Bachelor’s in Computer Science or Computer Engineering, or equivalent experience
• Prior experience at Staff, Principal, or Architect level
• Ownership in platform/infrastructure, developer productivity, CI/CD, build systems, or workflow automation, including work spanning globally distributed teams and systems.
• Strong, hands-on knowledge of:

• • Git (workflows, branching strategies, release management)
  • Jenkins (CI/CD pipeline design, scaling, reliability)
  • Docker containers (reproducible build/test execution)

Build systems ( itBake/Yocto preferred)

• Jira (workflow design/automation, cross-team visibility)
• Test management systems (e.g., TestRail or equivalent)
• Demonstrated experience delivering automation at scale, including building platforms/components used by multiple teams.
• Strong systems thinking across security, reliability, performance, and cost tradeoffs.
• Excellent written communication (architecture docs, decision records, operating procedures).
• Experience building AI-assisted developer tooling (e.g., CI insights, test intelligence, code review automation, release risk scoring, incident copilots).
• Experience implementing evaluation/monitoring for AI systems (quality metrics, drift, offline test sets, human feedback loops).
• Extensive experience with software development on embedded Linux,  multi-process architectures and IPC mechanisms
• Experience working in large cross functional teams and ability to influence teams that don't report to you
• Ability to see the big picture while focused on short-term objectives and deliverables
• Ability to multi-task and drive parallel projects and distributed teams with tight deadlines

#LI-NM1

Why Join Us?

As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and ARON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

What’s the opportunity?

The VP, Development Data Science will build and lead a cross functional data centric matrix to accelerate drug development, support regulatory submissions and guide the Real-World Data (RWD) / Real-World Evidence (RWE) function at Parabilis. This role is responsible for end-to-end strategy and execution of RWD/RWE and clinical data science to inform trial design, contextualize clinical results, support biomarker and translational work, and optimize site and patient selection.

The VP will partner closely with Clinical Development, Clinical Operations, Biostatistics, Translational/Computational Biology, Regulatory, and the broader Data Science & Engineering team to maximize the probability of success of our clinical programs.

• Strategy & Leadership
  • Define and own the Clinical Data Science strategy.
  • Serve as the senior Clinical Data Science leader and primary point of contact for RWD/RWE across programs aligned with portfolio and corporate objectives.
  • Represent Clinical Data Science on cross-functional governance and portfolio forums.
• RWD/RWE & Clinical Analytics
  • Design and oversee RWE studies to contextualize clinical trials, including synthetic/external control arms, patient matching, and trial emulation.
  • Use RWD to inform clinical trial design (eligibility criteria, endpoints, enrichment strategies), dose/regimen selection, and go/no-go decisions.
  • Contribute data science insights for feasibility and site selection, including epidemiology, patient journeys, referral patterns, and diversity/access.
  • Integrate RWD with internal clinical and biomarker data to support forward and reverse translation, target and indication strategy, and mechanism-of-resistance analyses.
  • Establish and maintain best practices in causal inference, comparative effectiveness, and time-to-event modeling relevant to RWE in oncology.
• Data Assets, Partnerships & Infrastructure
  • Identify, evaluate, and prioritize RWD sources (EHR, claims, registries, genomic/omic datasets, imaging, PROs) to support current and future clinical needs.
  • Lead collaboration and contracting with RWD providers and academic/industry partners in coordination with Commercial, Business Development, Legal, and Procurement.
  • Partner with Engineering and Data Science to define requirements for secure, scalable, compliant RWD infrastructure and analytic environments.
  • Ensure data quality, interoperability, and governance suitable for regulatory-grade analyses.
• Team Building & Management
  • Build and lead a high-performing Clinical Data Science team (e.g., RWE epidemiologists, clinical data scientists, etc).
  • Set clear objectives, provide regular feedback, and support growth and succession planning.
  • Foster a culture of scientific rigor, transparency, and effective collaboration with Clinical Development, Biostatistics, and other partners.
• Cross-Functional Collaboration & Communication
  • Work in an integrated way with Clinical and Development teams to define key questions and translate them into analytic and RWE plans.
  • Communicate complex methods, assumptions, and results clearly to clinical, technical, and executive stakeholders.
  • Support regulatory and payer/Health Technology Assessment interactions where RWE and clinical analytics contribute to program strategy (e.g., briefing documents, responses, meeting preparation).
  • Collaborate with Translational and Computational Biology to align biomarker and patient selection strategies with integrated clinical and RWD analytics.
• Governance, Quality & Compliance
  • Ensure RWD/RWE activities meet regulatory, ethical, and privacy standards (e.g., GCP, data de-identification and privacy requirements).
  • Implement documentation, reproducibility, and quality standards for Clinical Data Science analyses.
  • Monitor evolving external expectations for use of RWE in regulatory and payer settings and adapt internal practices accordingly.

What you’ll need to be successful:

• PhD, MD, PharmD, or MS in Epidemiology, Biostatistics, HEOR, Data Science, or a related quantitative field.
• 12–15+ years of experience in pharma/biotech, healthcare technology, or related sectors, with significant focus on RWD/RWE and clinical development; oncology experience strongly preferred.
• Proven track record designing and delivering impactful RWE studies to inform clinical, regulatory, or payer decision-making.
• Strong understanding of clinical trial design, biostatistics fundamentals, and translational/biomarker concepts, ideally in oncology or immuno-oncology.
• Demonstrated experience building, leading, and developing high-performing quantitative teams in a matrixed environment.
• Hands-on familiarity with major RWD types (EHR, claims, registries, genomic/omic datasets) and key vendors/platforms.
• Proficiency with modern analytic tools and programming environments (e.g., R, Python, SQL) and with guiding development of robust, reproducible analytic workflows.
• Excellent communication and influencing skills with the ability to engage effectively with clinicians, statisticians, senior leaders, and external partners.

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

• Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
• In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
• Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $325,000-$380,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive    |     Cambridge, MA 02140    |    www.parabilismed.com

Position Overview

We are seeking a detail-oriented Director, Compliance to join Iterative Health's growing team in New York, NY or Cambridge, MA. This role will be instrumental in leading the strategic development of compliance programs to ensure our clinical trial optimization solutions meet all regulatory requirements across healthcare, clinical trials, and data privacy domains. The ideal candidate will have deep expertise in healthcare compliance frameworks and the ability to operationalize complex regulatory requirements in a fast-paced health tech environment.

Key Responsibilities

Regulatory Compliance & Risk Management

• Experienced with the compliance aspects of clinical trial & clinical research
• Maintain comprehensive compliance with GDPR, HIPAA, and other applicable data privacy regulations
• Lead SOC 2 Type II audit preparation and ongoing compliance, including controls documentation and evidence collection
• Develop and implement compliance policies and procedures specific to clinical trial technologies and healthcare AI solutions
• Ensure adherence to Anti-Kickback Statute, Stark Law, and PhRMA Code requirements in all business relationships
• Monitor evolving AI regulations and their impact on clinical trial optimization platforms

Quality Management & Documentation

• Oversee Quality Management System (QMS) in partnership with other team members, for maintenance and contractual compliance 
• Establish and maintain comprehensive record retention policies across clinical, regulatory, and business functions
• Manage document control processes for clinical protocols, compliance documentation, and regulatory correspondence
• Coordinate with clinical operations team to ensure GCP compliance in trial management and data collection

Contract & Vendor Compliance

• Review and negotiate compliance terms in customer agreements, vendor contracts, and clinical trial agreements
• Conduct vendor risk assessments and ongoing compliance monitoring for third-party service providers
• Ensure contract compliance with healthcare customer requirements, including BAAs and data processing agreements
• Support commercial team with compliance aspects of customer onboarding and due diligence processes

Training & Cross-Functional Support

• Develop and deliver compliance training programs for employees across all functions
• Serve as primary compliance liaison with external auditors, regulators, and certification bodies
• Collaborate with legal, clinical, and product teams on regulatory strategy and risk mitigation
• Maintain compliance calendar and ensure timely completion of regulatory filings and renewals

Required Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Business, or a related field plus 8+ years of compliance experience in healthcare, biotech, or clinical research organizations; advanced degree preferred
• OR Juris Doctor (JD) or other advanced degree plus 5+ years of compliance experience in healthcare, biotech, or clinical research organizations
• Direct experience with clinical trial regulations and GCP requirements
• Proven track record managing compliance programs in regulated industries

Technical Expertise

• Employment law and HR compliance expertise, including workplace privacy, salary transparency, employee data protection, and regulatory training requirements
• Corporate governance and general business compliance including anti-corruption, export controls, and corporate record-keeping requirements
• Privacy program management across all business functions, including vendor privacy assessments and cross-border data transfer compliance
• Financial compliance awareness including regulatory reporting requirements
• Deep knowledge of GDPR and HIPAA requirements and implementation
• Hands-on experience with SOC 2 audits and information security compliance frameworks
• Familiarity with clinical research regulations (GCP, ICH guidelines, 21 CFR Part 11)
• Understanding of AI/ML regulatory landscape in healthcare and clinical trials

Core Competencies

• Strong analytical and problem-solving skills with ability to translate complex regulations into actionable policies
• Excellent written and verbal communication skills for regulatory correspondence and training delivery
• Project management experience with ability to manage multiple compliance initiatives simultaneously
• Detail-oriented approach with strong documentation and process improvement capabilities

Preferred Qualifications

• Professional certifications (CIPP, CISA, CCEP, CHRC, or similar compliance credentials)
• Experience with international regulations (EU Clinical Trials Regulation, other global markets)
• Background in clinical research or pharmaceutical compliance
• Familiarity with AI ethics and algorithmic bias considerations in healthcare
• Experience with healthcare technology or SaaS compliance programs

POS-32553

Job Description

At HubSpot, we aim to give employees the same thoughtful, high-quality experience we offer our customers, every day of their journey with us — from their first day in the office to their last. As part of the Global Facilities team, the Senior Manager, Facilities – Americas leads operations across our Americas offices, ensuring safe, reliable, and inspiring workplaces where employees and visitors can do their best work.

This role owns day-to-day facilities operations and workplace experience for our directly leased and partner-managed spaces in the Americas, manages regional vendors and building relationships, and leads a distributed team of coordinators and contingent staff. You will partner closely with Real Estate, Security, Business Technology, Workplace Experience and other key stakeholders to deliver a data-informed, employee-centric facilities strategy that scales with HubSpot’s growth.

In this role you will

Regional leadership & team management

• Lead and develop a high-performing regional facilities team (full-time, temporary, and contractor staff) across multiple Americas locations (e.g., Cambridge, San Francisco, Bogotá), providing coaching, direction, and day-to-day support.
• Set clear goals and priorities aligned to global Facilities and drive consistent operational standards across sites.
• Delegate and oversee work through our internal ticketing system, ensuring timely, high-quality responses to employee and stakeholder requests.

Facilities operations & maintenance

• Own day-to-day facilities operations for the Americas offices, including office readiness, space standards, and preventative maintenance for core building systems (HVAC, plumbing, electrical, furniture, fixtures, and equipment).
• Coordinate and resolve building and infrastructure issues (e.g., furniture failures, water heater problems, IDF/MDF spaces) in partnership with vendors, building engineers, and internal teams, from initial triage through to resolution and communication.
• Ensure that meeting rooms, cafes, collaboration spaces, and wellness areas meet high standards of quality, functionality, and cleanliness, supporting employee productivity and comfort.
• Maintain and update team workflows for all americas offices 

Vendor, building & contract management

• Serve as the primary Facilities point of contact for property managers, landlords, and key building stakeholders across the Americas region, maintaining strong relationships and clear operating rhythms.
• Source, scope, and manage vendors for services such as janitorial, carpet and floor care, furniture, blinds, mechanical/plumbing, and specialty trades — including obtaining quotes, validating scope, scheduling work, and monitoring performance.
• Partner with Procurement and Finance on purchase requests, POs, and cost optimization (e.g., scheduling to avoid overtime labor where possible, aligning work with building access windows).

Workplace experience & front-of-house support

• Ensure a consistently excellent front-of-house and visitor experience in Americas offices, including reception standards, wayfinding, and event support in collaboration with on-site teams.
• Oversee coordination of mail, shipping/receiving, and logistics, including high-value and international shipments in partnership with Business Technology and external carriers.
• Support office events, intentional gatherings, and other on-site activities by ensuring facilities, services, and vendors are aligned to program needs.
• Manage large office moves, terminations including desk assignments. 
• Maintain and update floorplans when changes happen or new offices open, this includes updating the CAFM system to ensure floorplans are up to date.
• Review and coordinate parking assignments notifying the appropriate individuals to provide access.

Health, safety, security & emergency readiness

• Act as a key regional contact for facilities-related emergencies, coordinating with Security, IT, and local building teams to respond to incidents across Americas sites (e.g., IDF/MDF issues, building systems failures, safety concerns).
• Maintain and contribute to emergency contact lists, playbooks, and on-site procedures for multiple locations, ensuring information is current, accurate, and visible to the right stakeholders.
• Partnering with Security and local offices leads to support physical security practices (e.g., access control, cameras, vendor access) and align with HubSpot’s safety expectations.

Projects, space changes & cross-functional collaboration

• Lead and support facilities components of office projects in the Americas (e.g., reconfigurations, furniture changes, programmatic improvements, capital projects) in partnership with Real Estate, Construction partners, BT, and local stakeholders.
• Collaborate closely with global Facilities and Real Estate peers to ensure alignment on standards, data, and reporting, and to share best practices across regions.
• Use ticketing and space data to identify trends, propose improvements, and inform prioritization and investment decisions across the Americas portfolio.

Documentation, communication & knowledge sharing

• Maintain and enhance Facilities documentation for Americas offices, including wiki content, emergency information, operating procedures, and office-specific guides.
• Communicate proactively with employees, partners, and leadership about facilities work, impacts, and timelines, ensuring transparency and building trust.

Our ideal candidate

• Has 7+ years of experience in facilities management, workplace operations, property management, or a related field, including multi-site responsibility and complex office environments.
• Has at least 5+ Years of people management experience, leading and developing distributed teams and working with contingent staff and vendors.
• Demonstrates strong vendor and stakeholder management skills and is comfortable working directly with landlords, property managers, and specialty contractors to solve operational issues.
• Is highly organized, able to prioritize across multiple offices, manage competing deadlines, and stay calm and effective in time-sensitive or emergency situations.
• Communicates clearly and empathetically in writing and in person, tailoring their style for employees, senior leaders, vendors, and building teams.
• Is data-informed and comfortable using ticketing systems and basic reporting to spot patterns, drive improvements, and measure the impact of facilities programs.
• Brings a strong customer-first mentality, with a passion for creating inclusive, welcoming, and accessible spaces for all employees and visitors.
• Aligns with HubSpot’s HEART values and is eager to collaborate across regions and functions to help our global team thrive.

Knowledge of Health & Safety practices, building systems, environmental sustainability, and physical security is a strong plus. Additional languages are a plus.

Diversity & inclusion

Confidence can sometimes hold people back from applying for a role, but there’s no such thing as a “perfect” candidate. HubSpot is a place where everyone can grow, so however you identify and whatever background you bring, please apply if this role excites you and you’re eager to support our teams across the Americas every day.

About HubSpot

HubSpot (NYSE: HUBS) is a leading customer relationship management (CRM) platform that provides software and support to help businesses grow better. We build marketing, sales, service, and website management products that start free and scale to meet our customers’ needs at any stage of growth. We’re also building a company culture that empowers people to do their best work and supports a diverse, inclusive workplace.

Thanks to the work of every employee globally, HubSpot has been recognized for our culture and as a great place to work by Glassdoor, Great Place to Work, Comparably, Fortune, Entrepreneur, and more. Today, thousands of employees work across the globe in HubSpot offices and remotely.

By submitting an application, candidates agree that HubSpot may collect their personal data for recruiting, global organization planning, and related purposes, as outlined in HubSpot’s Privacy Notice.

The Role:

Reporting to the Head of Contracts, the Senior Manager, Contracts - Clinical will serve as the primary contracts professional working closely with the Clinical function, particularly Clinical Operations. This is a hands-on, high-volume role responsible for the full lifecycle of clinical site agreements and ancillary clinical contracts across Nuvalent’s global study portfolio, currently spanning four concurrent studies including a Phase 3 randomized controlled trial.

The ideal candidate has deep experience in global clinical site contracting at a sponsor company or CRO, is comfortable operating with significant autonomy, and has the judgment to know when to resolve an issue independently and when to escalate. This role works directly alongside a peer team of Senior Contracts Managers within a contracts department that is growing alongside Nuvalent’s pipeline.

Responsibilities:

Clinical Site & Study Agreements

• Draft, review, negotiate, and execute Clinical Trial Agreements (CTAs) with academic medical centers, community research sites, and international investigator sites across global markets.
• Manage the full contract lifecycle from initial draft through execution, amendment, and close-out across a high-volume, multi-study portfolio.
• Coordinate Informed Consent Form (ICF) review as needed in connection with site-level contracting.
• Negotiate and process Work Orders (WOs) and Change Orders (COs) in coordination with Clinical Operations and relevant CRO or vendor counterparties.
• Serve as the primary contracts point of contact for site administrators, legal counsel, and CRO contract teams, maintaining productive counterparty relationships through complex negotiations.

Ancillary Clinical Contracts

• Draft, review, and negotiate Confidential Disclosure Agreements (CDAs) and Non-Disclosure Agreements (NDAs) for clinical partnerships and site-level engagements.
• Manage consulting agreements for clinical investigators, key opinion leaders, and clinical consultants engaged by Clinical and Clinical Operations, with appropriate escalation of HCP engagements for compliance review.
• Support statements of work and related agreements for Clinical and Clinical Operations vendors.

Contract Operations & Process

• Maintain accurate, complete, and timely contract records in Nuvalent’s contract management system (Agiloft), including status updates, executed document storage, and obligation tracking.
• Apply and enforce departmental file naming conventions, version control standards, and repository management protocols.
• Provide timely contract status visibility to Clinical and Clinical Operations business owners and serve as a reliable point of contact for internal stakeholders throughout the contract lifecycle.
• Identify issues requiring escalation and engage appropriate internal resources — including Legal, QA, Regulatory, Clinical Operations, Finance, IT, and Compliance — or external resources including CRO counterparties, outside counsel, or the Data Privacy Officer (DPO).
• Contribute to negotiation playbooks, standard fallback positions, and contract templates for clinical contract types.
• Coordinate with Legal and the DPO on data privacy provisions in clinical agreements, including GDPR data processing terms for EU and international site agreements.
• Utilize AI-assisted contract review tools as integrated into departmental workflow in accordance with established Nuvalent guidance.
• Lead or co-lead department initiatives to support an expanding organization.

Competencies Include:

• Detail and process oriented, with strong organizational skills and the ability to manage a high-volume, multi-study contract portfolio across competing deadlines and shifting priorities.
• Strong negotiation, problem solving, and communication skills, with the ability to hold a position, find common ground, and close without unnecessary escalation.
• Flexibility with changing priorities and ability to think critically under pressure.
• Ability to work in a collaborative environment and build effective working relationships across the organization, including with external counterparties such as site administrators, CRO contract teams, and outside counsel.
• Sound judgment in recognizing when to resolve independently and when to bring in the right internal or external resources.
• Able to thrive in a remote/virtual environment.

Qualifications:

• Minimum of 7 years of contracts experience in the biopharmaceutical or clinical research industry, with at least 4 years focused on vendor agreements, clinical site agreements, investigator agreements, or study start-up contracting; sponsor-side experience preferred, CRO-side experience considered.
• Demonstrated experience negotiating CTAs, WOs, COs, CDAs, and HCP consulting agreements at volume across multiple concurrent studies.
• Direct experience contracting with international clinical sites and working knowledge of applicable legal and regulatory requirements including GDPR data processing considerations.
• Working knowledge of GCP, ICH guidelines, and FDA regulations governing clinical research and their practical implications for contract terms.
• Familiarity with IRB processes and their intersection with site-level contracting.
• Proficiency with contract lifecycle management systems; experience with Agiloft, Ironclad, DocuSign CLM, or comparable platforms required. Agiloft experience a plus; training will be provided.
• Oncology experience preferred; relevant experience from adjacent therapeutic areas will be considered.
• Familiarity with AI-assisted contract review tools a plus.
• Bachelor’s degree or equivalent experience required.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

MORSE is seeking highly motivated and talented Software Engineers with Cloud skills to join our innovative team, supporting various projects that provide critical AI, machine learning, simulation, situational awareness, and mission planning capabilities to a diverse range of Department of Defense (DoD) customers.

As a Cloud Software Engineer at MORSE, you will have the opportunity to work on cutting-edge technology, contributing to the success of our applications and making a meaningful impact on our customers. You will collaborate with a teams of engineers and data scientists to design, develop, and deliver high-quality software products that meet the highest standards of quality, scalability, and reliability.

Responsibilities:

• Design and develop scalable, efficient, and reliable software applications using Python 

• Develop and maintain cloud infrastructure 

• oversee the deployment of cloud services and compliance to security guidelines

• Participate in design reviews, code reviews, and pair programming to ensure high-quality code and knowledge sharing

• Stay up-to-date with the latest software engineering trends, tools, and technologies

• Collaborate with cross-functional teams to deliver high-quality software products, ensuring seamless integration and deployment

• Contribute to the development of new codebases that emphasize object-orientation, modularity, and maintainability

Requirements:

• US citizenship and the ability to obtain a U.S. security clearance (Secret, Top Secret, or TS/SCI)

• Expertise in Python 

• 1+ years of experience working with AWS, Azure or GCP.

• Experience with Terraform or Cloud Formation

• Strong understanding of relational databases and version control systems (e.g., Git)

• Experience with Docker, Docker-compose, or Kubernetes

• Familiarity with Agile development methodologies (Scrum or Kanban) and microservice architecture

• Strong communication skills and self-motivation

• Bachelor's or Master's degree in Computer Science or a related field (or significant professional experience)

• 3+ years of software development experience

MORSE is seeking highly motivated and talented Software Engineers with Cloud skills to join our innovative team, supporting various projects that provide critical AI, machine learning, simulation, situational awareness, and mission planning capabilities to a diverse range of Department of Defense (DoD) customers.

As a Cloud Software Engineer at MORSE, you will have the opportunity to work on cutting-edge technology, contributing to the success of our applications and making a meaningful impact on our customers. You will collaborate with a teams of engineers and data scientists to design, develop, and deliver high-quality software products that meet the highest standards of quality, scalability, and reliability.

Responsibilities:

• Design and develop scalable, efficient, and reliable software applications using Python 

• Develop and maintain cloud infrastructure 

• oversee the deployment of cloud services and compliance to security guidelines

• Participate in design reviews, code reviews, and pair programming to ensure high-quality code and knowledge sharing

• Stay up-to-date with the latest software engineering trends, tools, and technologies

• Collaborate with cross-functional teams to deliver high-quality software products, ensuring seamless integration and deployment

• Contribute to the development of new codebases that emphasize object-orientation, modularity, and maintainability

Requirements:

• US citizenship and the ability to obtain a U.S. security clearance (Secret, Top Secret, or TS/SCI)

• Expertise in Python 

• 1+ years of experience working with AWS, Azure or GCP.

• Experience with Terraform or Cloud Formation

• Strong understanding of relational databases and version control systems (e.g., Git)

• Experience with Docker, Docker-compose, or Kubernetes

• Familiarity with Agile development methodologies (Scrum or Kanban) and microservice architecture

• Strong communication skills and self-motivation

• Bachelor's or Master's degree in Computer Science or a related field (or significant professional experience)

• 3+ years of software development experience

MORSE is seeking highly motivated and talented Python Software Engineers to join our innovative team, supporting various projects that provide critical AI, machine learning, simulation, situational awareness, and mission planning capabilities to a diverse range of Department of Defense (DoD) customers.

As a Python Software Engineer at MORSE, you will have the opportunity to work on cutting-edge technology, contributing to the success of our applications and making a meaningful impact on our customers. You will collaborate with a teams of engineers and data scientists to design, develop, and deliver high-quality software products that meet the highest standards of quality, scalability, and reliability.

Responsibilities:

• Design and develop scalable, efficient, and reliable software applications using Python 

• Participate in design reviews, code reviews, and pair programming to ensure high-quality code and knowledge sharing

• Stay up-to-date with the latest software engineering trends, tools, and technologies

• Collaborate with cross-functional teams to deliver high-quality software products, ensuring seamless integration and deployment

• Contribute to the development of new codebases that emphasize object-orientation, modularity, and maintainability

Requirements:

• US citizenship and the ability to obtain a U.S. security clearance (Secret, Top Secret, or TS/SCI)

• Expertise in Python 

• Strong understanding of relational databases and version control systems (e.g., Git)

• Experience with Docker, Docker-compose, or Kubernetes

• Familiarity with Agile development methodologies (Scrum or Kanban) and microservice architecture

• Strong communication skills and self-motivation

• Bachelor's or Master's degree in Computer Science or a related field (or significant professional experience)

• 5+ years of software development experience

Preferred Qualifications:

• Experience with cloud computing platforms (AWS, Azure, GCP)

• Knowledge of Spark or PySpark

• Background in mathematics or computer science

• Experience with DevOps tools and practices

• Familiarity with containerization technologies 

• Experience or desire to lead technical teams

MORSE is seeking highly motivated and talented Python Software Engineers to join our innovative team, supporting various projects that provide critical AI, machine learning, simulation, situational awareness, and mission planning capabilities to a diverse range of Department of Defense (DoD) customers.

As a Python Software Engineer at MORSE, you will have the opportunity to work on cutting-edge technology, contributing to the success of our applications and making a meaningful impact on our customers. You will collaborate with a teams of engineers and data scientists to design, develop, and deliver high-quality software products that meet the highest standards of quality, scalability, and reliability.

Responsibilities:

• Design and develop scalable, efficient, and reliable software applications using Python 

• Participate in design reviews, code reviews, and pair programming to ensure high-quality code and knowledge sharing

• Stay up-to-date with the latest software engineering trends, tools, and technologies

• Collaborate with cross-functional teams to deliver high-quality software products, ensuring seamless integration and deployment

• Contribute to the development of new codebases that emphasize object-orientation, modularity, and maintainability

Requirements:

• US citizenship and the ability to obtain a U.S. security clearance (Secret, Top Secret, or TS/SCI)

• Expertise in Python 

• Strong understanding of relational databases and version control systems (e.g., Git)

• Experience with Docker, Docker-compose, or Kubernetes

• Familiarity with Agile development methodologies (Scrum or Kanban) and microservice architecture

• Strong communication skills and self-motivation

• Bachelor's or Master's degree in Computer Science or a related field (or significant professional experience)

• 5+ years of software development experience

Preferred Qualifications:

• Experience with cloud computing platforms (AWS, Azure, GCP)

• Knowledge of Spark or PySpark

• Background in mathematics or computer science

• Experience with DevOps tools and practices

• Familiarity with containerization technologies 

• Experience or desire to lead technical teams

About the Role:

Stylus Medicine is seeking a highly motivated and collaborative Senior Scientist to join our in vivo Pharmacology team. This role will be responsible for leading NHP studies, including working closely with CROs to manage studies, contribute to protocol writing and design, obtain, quality control, analyze and interpret data, lead investigative technical troubleshooting, ensure consistency in execution across studies, and create detailed and thorough study summaries. Reporting to the Director of in vivo Pharmacology and working closely with cross-functional teams, this is a unique opportunity to contribute to foundational development in a fast-paced, cutting-edge biotech environment and advance the development of transformative in vivo genetic medicines.

Key Responsibilities & Accountabilities: 

• Design NHP study protocols and lead CRO communication
• Analyze, interpret, and communicate NHP study data, including flow cytometry analysis, cytokine analysis and other ex vivo readouts, to inform project direction and decision-making
• Evaluate data for consistency and follow-up as needed, working closely with CROs to optimize study protocols
• Investigate and interpret biological findings from NHP studies
• Manage NHP study test article generation and transfer in collaboration with internal cross-functional teams
• Conduct experiments to optimize protocols for CRO transfer or investigate biological findings
• Generate and manage study documentation, including protocols and study reports
• Effectively communicate findings to internal teams.
• Maintain detailed and accurate laboratory records in compliance with data integrity and documentation standards
• Limited travel may be required

 Qualifications & Skills:

• PhD in Pharmacology, Immunology, Immuno-oncology, or a related field with 4-6 years of relevant industry or academic experience, or a Master's degree with 8+ years of experience
• Demonstrated experience with ex vivo analytical techniques, such as flow cytometry, cytokine analysis, and ddPCR
• Demonstrated ability to design, execute, interpret, and troubleshoot immunology-related in vivo studies and to coordinate the activities of multiple study contributors
• Experience coordinating with animal vendors, CROs or external collaborators
• Prior experience with NHP studies is preferred
• Experience in designing experiments to address PK/PD/biodistribution/tox relationships is a plus
• Experience with LNP or CART delivery technologies and genetic medicine platforms is a plus
• Experience with T cell or PBMC isolation and handling from peripheral blood, engineering, and downstream immunological or molecular assays
• Demonstrated ability to work independently in a laboratory setting, learn new techniques, multitask effectively, and maintain meticulous records
• Demonstrated proficiency in documenting and maintaining an organized lab notebook, lab inventory, and experimental results
• Excellent organizational and communication skills, with a team-first mindset and the ability to convey technical information
• Analytical thinker with the ability to distill complex data into clear, actionable insights

Pay Range: $160,000 - $175,000

The Role:

Reporting to the Director of Supply Chain Management, the Associate Director, Supply Chain Logistics & Compliance will lead import / export, trade compliance and support global logistics who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment. This role is responsible for ensuring compliance, efficiency, and cost-effective cross-border movements of goods, while supporting global supply chain strategies, regulatory requirements, and commercial objectives.  The ideal candidate brings subject matter expertise in import/export processes, customs compliance and global distribution networks, along with proven leadership expertise.

This position will allow for growth within the company and contribute to your valuable experience in establishing policies and procedures for the Supply Chain department during a critical time. You will work closely with many cross-functional areas and will be able to contribute to their practices for a more efficient, cost-effective, and compliant supply chain.  Our fast-paced environments and hands-on opportunities will challenge you to innovate and learn while having fun with supportive and passionate colleagues.

Responsibilities:

• Lead Import/Export activities, ensuring full compliance with global customs regulations, export controls and trade sanctions
• Oversee product classification (HTC) valuation, country of origin, and accurate preparation of shipping documentation
• Develop, implement, and continuously improve global trade compliance processes, SOPS, and internal control mechanisms
• Direct liaison with customs authorities, brokers and regulatory agencies
• Monitor and interpret evolving global trade regulations, ensuring timely implementation of changes
• Design and manage global distribution networks to support commercial and clinical supply needs
• Drive optimization of routes, carriers and distribution models to balance cost, speed, and compliance
• Establish and track KPIs such as customs clearance time, on-time delivery, cost per shipment, and compliance metrics
• Ensure visibility across the supply chain through tracking and proactive exception management
• Identify and mitigate risks related to cross-border shipments including delays, regulatory issues, and geopolitical factors
• Ensures adherence to cGMP and GSP/GDP regulations.
• Partner with Quality and Regulatory to support inspections and ensure audit readiness
• Demonstrated leadership experience in global distribution and cross-border operations
• Advanced knowledge of international trade regulations, customs compliance, and export control framework
• Strong understanding of Incoterms, tariff classification, customs valuation, and documentation
• Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex 6, 13) and knowledgeable of relevant commercial laws and regulatory guidelines.

Competencies:

• Effective communicator with strong stakeholder management
• Detail-oriented with a strong compliance mindset
• Encourages collaboration, innovation and new ideas while integrating information from various sources. 
• Demonstrated ability to develop and foster relationships with internal and external stakeholders.   
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
• Excellent problem solving, communication and organization skills.

Qualifications:

• Education Required: Bachelor’s degree in business administration, Operations Management, Engineering or similar required. Advanced degree preferred.
• 10+ years progressive experience in logistics within the biotech/pharmaceutical industry with strong emphasis on import/export and trade compliance.
• Due to the global nature of the company, early morning or evening meetings are required. Potential Travel: 10%
• Experience in change management, deviation investigation and CAPA implementation.
• Experience in vendor oversight and managing external partnerships and relations.
• Experience with small molecule supply chain.
• Experience with lane risk assessments, and shipping lane/process qualification including IQ, OQ, PQ

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Opportunity:

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.

Your Role: 

• You will serve as CMC-regulatory lead for assigned projects.
• Develop and execute CMC global submission plans and timelines in accordance with project goals
• You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs.
• You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
• You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable.
• You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership.
• You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects.

Competencies:

• Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
• Proven ability to lead and manage regulatory CMC projects with minimal supervision
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
• Positive attitude, energetic and proactive.
• Strong technical writing and document review skills.
• Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
• Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
• Ability to effectively manage multiple projects with competing priorities.

Your Qualifications:

• Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 8+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus preferably on CMC for small molecules and oral solid products.
• Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
• Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs.
• Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates / requirements.
• Authoring experience of CTD Module 2 & Module 3 sections.

Estimated Salary Range: [$145,000 - $207,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1

Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA.  A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations. 

We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview

Prime Medicine is seeking a talented and motivated Sr. Manager to join the Analytical Development & QC team within Technology, Development & Operations. This role will focus on Quality Control (QC) related activities for all programs, including management and technical oversight of tech transfer, qualification/validation and release and stability testing carried out at both CDMOs, CTLs and internally at Prime for our prime editing ex vivo cell therapy and in vivo LNP-based drug products.

The successful candidate will have deep understanding of method lifecycle management, including method optimization, qualification, validation/verification, transfer, and implementation in a cGMP environment, as well as previous hands-on experience in at least some aspects of the above. This is a role requiring strong cross-functional collaboration with Analytical Development, Quality, Process Development, Formulation, Informatics, and external partners (CTLs/CDMOs). 

The ideal candidate thrives in a matrixed, fast-paced environment, works effectively with limited supervision, and demonstrates strong technical ownership and execution.

Key Responsibilities

• Design or review analytical procedures and protocols supporting method lifecycle activities, including optimization, qualification, validation, transfer, verification, performance monitoring, bridging, and comparability studies
• Manage and conduct select release, stability, and in-process testing for drug substances, drug products, and gene-editing components, and carry out data analysis and trending
• Support and/or manage analytical method transfer to CTLs/CDMOs, providing oversight, troubleshooting, and ensuring technical and timeline objectives are met
• Manage GMP sample inventory and chain-of-custody documentation
• Lead, manage and maintain well-designed stability programs and reference standard programs
• Author and review protocols, reports, SOPs, and analytical sections of regulatory submissions
• Familiarity with and ability to learn and use new tools for productivity, project management, documentation, tracking scheduling, and data management.
• Support IQ/OQ/PQ of QC equipment and ensure compliance with 21 CFR Part 11
• Maintain GxP-compliant electronic documentation and thorough laboratory records
• Collaborate with Quality to ensure data integrity, regulatory compliance, and audit readiness
• Lead or support investigations, deviations, and root-cause analyses
• Present data and findings to cross-functional teams
• Prepare technical reports and documents for global regulatory submissions

Qualifications

Education & Experience

• BS/MS/PhD in Biochemistry, Molecular biology, Chemistry, Bioengineering, or a related discipline
• Industry experience:
• BS: 10+ years
• MS: 8+ years
• PhD: 3+ years

Technical Expertise

• Experience with analytical method optimization, tech-transfer, qualification, validation, and verification used for critical components, drug substance and drug product release and stability testing
• Hands-on experience with analytical methodologies such as:
• Chromatography-based assays
• Absorbance-based assays
• Cell-based assays
• Compendial assays
• Molecular-based assays
• Flow cytometry assays
• Familiarity with ICH and FDA guidelines for CMC development during clinical stage is required
• Experience in advanced cell and gene-editing therapeutics development is not mandatory, but highly desirable
• Experience working with CMOs/CDMOs is required
• Experience with stability and/or reference standard programs is a plus
• Knowledge of assays, instrumentation, and facility qualification/validation requirements is desirable
• Familiarity with regulatory writing

Personal Attributes

• Highly self-motivated with strong project ownership
• Strong collaborator with internal cross-functional and external partners
• Adaptable in a dynamic, fast-paced environment
• Detail-oriented with strong troubleshooting and problem-solving skills
• Excellent written and verbal communication skills
• Strong abilities to lead and facilitate technical meetings with CDMO and CTL SMEs
• Work with purpose and drive meaningful results
• Ability to innovate and challenge industry status quo
• Ability to travel for up to 5 - 10% of the time

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

Position Overview:

Beam is seeking a highly motivated individual to join our Supply Chain team. The Supply Planning & Network leader will be responsible managing the global supply network performance by conducting risk-based inventory reviews and developing strategic options to address demand uncertainties and enhance network capabilities. He/she will be accountable to ensure uninterrupted supply of clinical and future commercial products via Beam’s S&OP process. This role will report to the Sr. Director of Global Supply Chain Planning and partner with TechOps, Clinical Ops, Commercial Patient Ops, Quality, Finance, and CMC teams to lead short-term integrated production planning and long-range strategic supply chain planning of Beam’s product portfolio. The role will be responsible for leading a global inventory management program to ensure critical material availability at Beam NC & CDMO mfg sites. The role will be integral to enhancing site planning and scheduling capabilities at Beam’s mfg site in Durham, NC and partnering with SAP business lead on further advancing technology capabilities. The ideal candidate will have a demonstrated track record of leading in a dynamic environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross functional relationships.

Responsibilities:

• Production & Capacity Planning: Develop and maintain a rolling 12–24-month master production schedule (MPS) aligned with demand forecasts and manufacturing constraints.
• External Network Collaboration: Lead planning and partner with key stakeholders to ensure supply continuity across the Contract Manufacturing Organizations (CMOs) and 3PLs.
• Sales & Operations Planning (S&OP): Drive the monthly S&OP cycle, including rough-cut capacity planning and scenario analysis. Partner cross-functionally to refine demand forecasts and execute supply network analysis to support both tactical and strategic goals.
• Inventory Optimization: Ensures appropriate inventory levels to minimize excess while preventing stockouts, specifically managing shelf-life/expiry for temperature-sensitive products like Critical Materials (pDNA, mRNA, gRNA, mAb, lipids), Drug Substance, and Bulk/Finished Drug Product.
• Clinical/Launch Readiness: Orchestrate supply for clinical trials or support new product introductions (NPI) and commercial launches.
• Risk Management: Proactively identify supply disruptions and develop mitigation strategies or business continuity plans.
• Process Improvement: Drive Global Supply Chain excellence through project management, process enhancement, and the deployment of digital tools that streamline business execution and strategic decision-making.
• Metrics: Leverage data-driven KPIs to track performance, ensuring accountability and optimizing the balance between operational efficiency and financial health.
• Systems: Optimize supply and inventory planning accuracy through utilization of SAP, driving improved stock maintenance and network visibility. Spearhead the design and execution of SAP enhancements, including Integrated Business Planning (IBP) and Jurisdictional Control (JC), to streamline end-to-end supply chain functions.
• Other duties as assigned.

Qualifications:

• BS/BA degree in Business, Science, Engineering or related field with 8-10+ years of experience in global supply chain from pharma, biotech or cell & gene therapy companies.
• Master's degree or MBA preferred.
• Prior drug development, manufacturing, and clinical operations experience is a plus.
• Final title/scope of role will be commensurate with experience.
• Passion for patients, collaborative and effective leader.
• Knowledge of practical implications of Sarbanes-Oxley controls.
• Knowledge of continuous improvement methodologies and tools.
• Strong organizational and facilitation skills, with high degree of customer focus.
• Expertise and track record in manufacturing and supply chain execution and oversight.
• Extensive experience in supply chain planning, SAP ERP system, capacity modeling, supply network strategy and optimization.
• Expertise and have a proven track record in supply chain risk management.
• Solid knowledge of regulatory requirements, regulatory guidance, including pharmaceutical GMPs and ICH guidance.
• Current on Biopharma supply chain, manufacturing technologies, supplier network, CMO network, performance and capacity.
• Possesses understanding and application of principles, concepts, practices, and standards for DS and DP manufacturing in the biopharma industry.
• Strong communication, negotiation, and interpersonal skills.
• Strong analytical skills and ability to clearly communicate at tactical and strategic level with team and Sr Management.
• Ability to work in a dynamic and challenging environment.
• Some travel may be required.
• Must be able to work onsite, not a remote role.

Your Impact at LILA

The Director, Discovery Chemistry will lead the design, synthesis, and optimization of small molecules across Lila’s discovery platform, with a primary focus on organic synthesis, molecular design, and scalable chemistry execution. This leader will build and scale a world-class molecular chemistry program that translates AI-generated molecular hypotheses into high-quality, synthetically tractable, and functionally validated chemical matter.

Working closely with Lila’s AI, automation, computational, biology, and platform teams, this role will establish the chemistry infrastructure required to rapidly progress novel molecules from concept to validated candidates across a broad range of discovery efforts. The Director will drive synthetic strategy, route design, analog generation, molecular property optimization, and chemistry-enabled innovation, while enabling seamless integration with robotic synthesis and platform-based experimentation.

This leader will play a central role in shaping Lila’s molecular discovery engine by combining deep expertise in synthetic organic chemistry, molecular design, and data-enabled experimentation to accelerate the discovery of high-value molecules for therapeutic and broader platform applications.

What You'll Be Building

• Drive discovery chemistry strategy across discovery programs, with strong emphasis on small molecule design, synthetic innovation, analog generation, and optimization of chemical matter.
• Lead the design and execution of synthetic routes for novel small molecules, emphasizing speed, robustness, scalability, and compatibility with automated synthesis platforms.
• Develop and implement efficient workflows for molecular design, compound prioritization, analog generation, and iterative design–make–test cycles in collaboration with AI and computational teams.
• Partner closely with automation and platform teams to establish robotic and high-throughput chemistry capabilities that expand accessible chemical space and accelerate molecule generation.
• Guide the selection of reagents, reaction modalities, and synthetic methodologies to enable rapid exploration of structurally diverse and functionally relevant chemical matter.
• Drive discovery chemistry strategy across discovery programs, with strong emphasis on small molecule design, synthetic innovation, analog generation, and optimization of chemical matter.
• Lead the design and execution of synthetic routes for novel small molecules, emphasizing speed, robustness, scalability, and compatibility with automated synthesis platforms.
• Develop and implement efficient workflows for molecular design, compound prioritization, analog generation, and iterative design–make–test cycles in collaboration with AI and computational teams.
• Partner closely with automation and platform teams to establish robotic and high-throughput chemistry capabilities that expand accessible chemical space and accelerate molecule generation.
• Guide the selection of reagents, reaction modalities, and synthetic methodologies to enable rapid exploration of structurally diverse and functionally relevant chemical matter.
• Oversee molecular optimization by integrating chemistry principles including structure–activity relationships, physicochemical properties, selectivity, developability, and synthetic tractability.
• Collaborate with biology, screening, and profiling teams to interpret assay and characterization data and translate those insights into informed molecular design decisions.
• Drive discovery efforts from early chemical matter generation through optimization of advanced molecules, including scaffold evolution, property tuning, and progression toward candidate-quality compounds.
• Establish best practices for experimental design, chemistry data capture, compound registration, quality control, and reproducibility across molecular chemistry operations.
• Contribute strategically to program direction by aligning chemistry efforts with therapeutic hypotheses, platform capabilities, and broader company priorities.

What You’ll Need to Succeed

• PhD in Organic Chemistry, Medicinal Chemistry, Chemical Biology, or a closely related discipline with 12–15 years of experience in small molecule discovery and molecular design.
• Demonstrated experience building and leading high-performing chemistry teams, including hiring, mentoring, and developing scientists across multiple levels.
• Proven track record advancing small molecule programs through molecular design, high-throughput synthesis, optimization, and candidate progression.
• Deep expertise in synthetic organic chemistry, retrosynthesis, route design, and practical execution of complex multistep syntheses.
• Strong experience optimizing molecular properties, including potency, selectivity, physicochemical behavior, and overall developability of small molecule series.
• Demonstrated success designing and delivering compound libraries or analog series to efficiently explore chemical space and address multiparameter optimization challenges.
• Experience working effectively in highly interdisciplinary environments spanning chemistry, biology, automation, and computational sciences.
• Experience collaborating with biology, screening, pharmacology, or related functions to incorporate experimental data into chemistry decision-making.
• Strong understanding of compound quality standards, purification and characterization workflows, and chemistry data integrity.
• Track record of scientific leadership, program delivery, and advancing discovery-stage molecules in an industrial or high-performance research environment.

Bonus Points For

• Experience working in AI-enabled discovery environments or integrating computational design and machine learning insights into chemistry workflows.
• Experience building or scaling automated, robotics-enabled, or high-throughput chemistry platforms for molecular synthesis and optimization.
• Familiarity with modern synthesis-enabling technologies.
• Experience translating chemistry needs into platform requirements, including instrumentation selection, workflow design, and integration with automated systems.
• Broad understanding of molecular design principles across therapeutic discovery and other small-molecule innovation areas.
• Experience operating in fast-paced environments where scientific creativity, speed, and cross-functional execution are critical.
• Ability to evaluate synthetic feasibility alongside innovation potential to prioritize molecules and chemical series effectively.
• Strong communication and leadership skills, with the ability to align multidisciplinary teams around ambitious scientific goals.

Your Impact at LILA

We're building a talent-dense, high-agency AI safety team at Lila that will engage all core teams within the organization (science, model training, lab integration, etc.), to prepare for risks from scientific superintelligence. The initial focus of this team will be to build and implement a bespoke safety strategy for Lila, tailored to its specific goals and deployment strategies. This will involve technical safety strategy development, broader ecosystem engagement, as well as developing technical collateral including risk- and capability-focused evaluations and safeguards.

What You'll Be Building

• Design and build capability evaluations to test for scientific risks (both known but especially novel) from cutting edge scientific models integrated with automated physical labs, across biological / physical sciences.
• Coordinate and lead threat modelling exercises with internal and external scientific experts, including monitoring for emerging technologies and use-cases.
• Develop and curate high-quality training and test data for evals and safety systems.
• Evaluate risks from Lila’s capabilities, including through interactions with the wider ecosystem of capabilities (e.g. general-purpose frontier models as well as narrow scientific tools)
• Contributing to broader, high-quality research efforts - as and when needed - for scientific capability evaluation and restriction.
• Contribute to external communications on Lila’s safety efforts.

What You’ll Need to Succeed

• A PhD in either a biological sciences domain (e.g., molecular biology, virology, computational biology or related fields) or a physical sciences domain (materials sciences, physics, chemistry, chemical or nuclear engineering, or related fields), or other related experience.
• Experience in scientific computing, across either biological or physical sciences.
• Familiarity with dual-use research and dissemination concerns, across the relevant safety / regulatory / governance frameworks (e.g. export control frameworks, biological and chemical-related conventions and controls).
• Ability to communicate complex technical concepts and concerns to non-expert audiences effectively.
• Demonstrated ability to lead teams of internal and external collaborators in buildout of Lila’s point-of-view on biological / physical risks
• Demonstrated ability to deal with cross-functional stakeholders (science, AI, product, policy) in a complex environment.

Bonus Points For

• Experience in developing or applying ML to biological or physical sciences
• Experience in building evaluations, or conducting red-teaming exercises, across scientific risks for frontier models / narrow scientific tools.

• This position may be based in any of Lila's offices, including Cambridge (MA), San Francisco (CA), or London (UK).

• For US-based candidates (Cambridge or San Francisco), we expect the base salary for this role to fall between $176,000–$304,000 USD per year, along with bonus potential and generous early equity. The final offer will reflect your unique background, expertise, and impact.
• For UK-based candidates, compensation will be determined separately and will be aligned with local market benchmarks and internal leveling.

Your Impact at LILA

Lila Sciences is seeking a highly skilled, hands-on Automated Systems Engineer to design, develop, and implement automation solutions across a broad range of laboratory workflows. Reporting to the Automated Systems Engineering Lead, this role is critical to building scalable, high-throughput automated workcells that translate scientific intent into reliable, real-world systems.

This role serves as a steward of scientific and cross-functional requirements—working closely with scientists, hardware, controls, and software teams to define scope, align interfaces, and drive projects from concept through deployment. The successful candidate will actively partner with scientific partners helping shape the technical direction of experimental automation in a fast-moving research environment.

What You'll Be Building

• Actively contribute to hands-on development, testing, and implementation of automated workflows in the lab.
• Develop scalable automated solutions for synthesis and characterization workflows, supporting a variety of material systems such as porous materials, catalysts, coatings, and advanced composites.
• Define and document standardized laboratory workflows, operating procedures, and system architectures to support reproducibility and scale.
• Lead and participate in equipment- and system-level FMEAs to improve robustness and operational safety.
• Assist in the troubleshooting and optimization of automated systems for throughput, reliability, and adaptability across diverse workflows.
• Design failure detection methods and maintain laboratory automation systems to ensure robust operations.

Project Innovation

• Translate scientific objectives into well-scoped technical requirements and automation architectures.
• Act as a connective tissue between science, hardware, controls, and software—ensuring interfaces are clear and solutions are cohesive.
• Explore and integrate emerging technologies, such machine vision, and advanced sensors, to enhance automation capabilities.
• Ensure alignment of automation solutions with safety, quality, and regulatory standards.

What You’ll Need to Succeed

• Strong hands-on experience developing and scaling automated workflows in laboratory or industrial settings.
• Understanding of Python programming, including API integration and error handling.
• Understanding of CAD design and rapid prototyping, including 3D printing.
• Hands-on experience with hardware systems, including electrical wiring, sensors, liquid/gas plumbing, and PID controllers.
• Strong critical thinking skills, attention to detail, and ability to work collaboratively in a dynamic environment.
• Excellent communication and interpersonal skills, with the ability to convey technical concepts clearly to diverse audiences.
• Familiarity with advanced experimental systems, including vacuum, laser, furnace, and electrochemical experimentation.
• Knowledge of machine vision applications and robotics control algorithms.
• Proven ability to integrate hardware and controls systems with automation workflows.
• Understanding of AI-driven decision-making in research automation.
• Prior experience leading technical teams in a fast-paced R&D environment.

Bonus Points For

Working at Lila Sciences, you would have access to advanced technology in the areas of:

• AI experimental design and simulation
• Automated custom instrumentation
• Generative molecular and material design

Your Impact at LILA

We're building a talent-dense, high-agency AI safety team at Lila that will engage all core teams within the organization (science, model training, lab integration, etc.), to prepare for risks from scientific superintelligence. The initial focus of this team will be to build and implement a bespoke safety strategy for Lila, tailored to its specific goals and deployment strategies. This will involve technical safety strategy development, broader ecosystem engagement, as well as developing technical collateral including risk- and capability-focused evaluations and safeguards.

What You'll Be Building

• Set the build and research strategy for Lila’s safety approach to biological / physical risks.
• Design and build capability evaluations to test for scientific risks (both known but especially novel) from cutting edge scientific models integrated with automated physical labs, across biological / physical sciences.
• Coordinate and lead threat modelling exercises with internal and external scientific experts, including monitoring for emerging technologies and use-cases.
• Develop and curate high-quality training and test data for evals and safety systems.
• Evaluate risks from Lila’s capabilities, including through interactions with the wider ecosystem of capabilities (e.g. general-purpose frontier models as well as narrow scientific tools)
• Contributing to broader, high-quality research efforts - as and when needed - for scientific capability evaluation and restriction.
• Contribute to external communications on Lila’s safety efforts.

What You’ll Need to Succeed

• A PhD in either a biological sciences domain (e.g., molecular biology, virology, computational biology or related fields) or a physical sciences domain (materials sciences, physics, chemistry, chemical or nuclear engineering, or related fields), or other related experience.
• Demonstrated ability to set research directions for open problems in dual-use risks in the biological / physical sciences.
• Experience in scientific computing, across either biological or physical sciences.
• Familiarity with dual-use research and dissemination concerns, across the relevant safety / regulatory / governance frameworks (e.g. export control frameworks, biological and chemical-related conventions and controls).
• Ability to communicate complex technical concepts and concerns to non-expert audiences effectively.
• Demonstrated ability to lead teams of internal and external collaborators in buildout of Lila’s point-of-view on biological / physical risks
• Demonstrated ability to deal with cross-functional stakeholders (science, AI, product, policy) in a complex environment.

Bonus Points For

• Experience in developing or applying ML to biological or physical sciences
• Experience in building evaluations, or conducting red-teaming exercises, across scientific risks for frontier models / narrow scientific tools.

• This position may be based in any of Lila's offices, including Cambridge (MA), San Francisco (CA), or London (UK).

Your Impact at LILA

We are seeking a motivated and detail-oriented Senior Research Associate / Associate Scientist to join our high-throughput autonomous chemistry team. This is a hands-on role at the intersection of organic and inorganic synthesis, advanced characterization, and laboratory automation. You will design and execute high-throughput experiments, synthesize small molecules, and perform rigorous downstream analysis while working side-by-side with senior scientists to translate ambitious product goals into scalable experimental workflows that directly drive our company’s growth.

This position offers first-hand exposure to automated chemistry platforms, with real ownership over experiments that inform company strategy and scientific direction. Ideal candidates are execution-driven, thrive in fast-paced laboratory environments, and are eager to build deep technical expertise while contributing meaningfully to next-generation chemical discovery at Lila Sciences.

What You'll Be Building

• Independently execute experiments to synthesize, purify, and characterize organic and inorganic small molecules
• Optimize reactions, perform method development, and interpret analytical data to guide project decisions
• Translate early-stage ideas into reproducible, functional experiments
• Apply retrosynthetic planning to support target molecule synthesis
• Operate Schlenk lines, gloveboxes, and other inert-atmosphere systems for sensitive compounds
• Use PAT tools (UPLC, LCMS, NMR, IR, Fluroescence, DLS) to monitor reactions, ensure quality control, and generate high-quality data for ML workflows
• Leverage automation and AI-driven platforms to accelerate workflows and reduce experimental cycle times
• Collaborate with engineers, ML scientists, and stakeholders to validate model-suggested conditions, analyze trends, troubleshoot issues, and communicate results clearly through reports, discussions, and presentations
• Document results, maintain accurate digital records and adhere to EHS and laboratory best practices

What You’ll Need to Succeed

• M.S. in Chemistry or related discipline (organic, organometallics, catalysis) with 2+ years of hands-on high-fidelity laboratory experience in an academic or industry setting, or B.S. + 5 years
• Hands-on experience in organic/inorganic synthesis, purification, chromatographic techniques, product analysis
• Strong understanding of retrosynthesis, reaction mechanisms, and method optimization workflows
• Proficiency with analytical techniques such as TLC, HPLC, LCMS, NMR, and IR
• Ability to follow SOPs and work safely with diverse chemical reagents and automated platforms
• Ability to thrive in a fast-paced, multidisciplinary research environment
• Required proficiency in using SciFinder, Reaxys, Chemdraw to search public database and literature
• Basic proficiency in Python or other scripting languages for data handling
• Good document practices, strong attention to detail and a proactive, problem-solving mindset
• Effective oral and written communication skills; contributed to internal reports, technical documentation, or peer-reviewed publications

Bonus Points For

• Experience with high-throughput or AI-driven automated platforms
• Authored publications in peer-reviewed journals in chemical catalysis, organic methodology
• Ability to handle air/moisture/light sensitive compounds

Your Impact at LILA

Lila Sciences is hiring a Software Engineer to develop the next generation of Lab Instrument Integration Software, which is a foundational component of our AI-enabled laboratory. We are looking for self-motivated problem solvers who enjoy sitting at the often tricky interfaces between software, science, and hardware to deliver powerful solutions that will accelerate science.

What You'll Be Building

• Lab Instrument Software Development: Develop robust software to enable communication between robotics and automation hardware (e.g., robotic arms, liquid handlers, sensors) and the control software, ensuring reliable and efficient hardware integration.
• System Integration: Seamlessly integrate lab instruments into our Next Generation, AI-enabled lab automation infrastructure, managing complex interfaces between cloud and edge infrastructure, and device execution.
• Testing and Debugging: Perform rigorous testing, debugging, and troubleshooting of drivers to identify, isolate, and rectify performance issues, bugs, and compatibility challenges.
• Technical Documentation: Create, update, and maintain clear, comprehensive documentation for driver interfaces, APIs, and integration methods, facilitating ease of use by internal teams and end-users.
• Collaboration and Support: Work closely with cross-functional teams, including hardware engineers, software developers, product managers, and end-users, providing technical support and resolving integration challenges promptly.
• AI driven development: work with state of the art coding models and development infrastructure to improve the speed and quality of software delivery.

What You’ll Need to Succeed

• Proficiency in Python, C#/.NET, or other programming languages or frameworks is essential
• Demonstrated ability in debugging and problem-solving, preferably hardware-software integration issues.
• Strong analytical thinking and a structured approach to troubleshooting and resolving complex technical problems.
• Strong verbal and written communication skills to collaborate effectively with multidisciplinary teams.

Bonus Points For

• A strong interest in or background in science
• Experience in developing software for laboratory automation systems or robotics used in life sciences, pharmaceutical, or similar industries.
• Experience working directly with end-users (e.g., scientists, laboratory technicians), using feedback to drive product improvements.
• Experience with hardware integration and device driver development, especially in robotics or automation contexts.
• Proficiency with version control systems, especially Git.

Your Impact at LILA

Lila Sciences is seeking an experienced Staff/Principal Mechanical Engineer to join our Hardware & Controls Engineering team. The specific title (Staff or Principal) will be determined based on experience level and expertise. As a key technical leader, you'll leverage your deep expertise to design and engineer components for workcell robotics, mechanical systems, and automation across life science and physical science domains. You'll collaborate with experimental scientists, AI/ML scientists, software/controls engineers, and process/automation engineers to lead complex projects, guide multidisciplinary teams, and deliver state-of-the-art automation solutions.

What You'll Be Building

• Lead the design and implementation of bench-scale robotics and mechanical systems for sophisticated automation in life science and physical science applications.
• Design innovative pneumatic, electro-mechanical, and optical solutions for advanced robotic workcells used in biological research and materials discovery.
• Lead and mentor teams in advanced CAD design and analysis using SolidWorks, optimizing systems for high-throughput workflows.
• Direct the creation and validation of designs through 3D printing, laser cutting, and other rapid prototyping methods.
• Lead cross-functional collaborations to integrate mechanical designs with software and controls across scientific domains.
• Develop strategies to transform manual processes into automated workflows while maintaining rigorous safety and quality standards.
• Coordinate with external vendors for custom component development and system integration.

What You’ll Need to Succeed

• Bachelor's or Master's degree in Mechanical Engineering, Robotics, or a related field.
• 8+ years of mechanical engineering experience with proven expertise in life science and physical science automation (title will be determined based on experience & expertise).
• Extensive proficiency in SolidWorks CAD design, GD&T, and DFMA
• Extensive proficiency working with & implementing requirement management systems, product lifecycle management, & product data management.
• Demonstrated leadership in managing complex projects and mentoring engineering teams.

Bonus Points For

• Deep experience in automation across scientific domains, with expertise in SolidWorks CAD design, PDM Vault management, rapid prototyping, and mechanical testing.
• Expert knowledge of motion control and mechatronic systems for diverse scientific applications.
• Strong background in automated systems and robotic integration for biological research, and materials science in the biotech sector.
• Demonstrated strong attention to detail in documentation, adherence to standards, and equipment management.
• Experience in automotive manufacturing, battery manufacturing, semiconductor manufacturing, and packaging with discrete material movement.

Your Impact at LILA

As Lila scales its AI Science Factories globally, the VP of Engineering will create and sustain an engineering model for a unified, scalable platform for autonomous experimentation. This role will be responsible for defining and implementing that platform across hardware, automation, and systems engineering. This executive will own strategy, execution, and talent across Lila’s systems, hardware, and automation engineering. The role sits on the senior leadership team, reports directly to the Chief Autonomous Science Officer, and interfaces directly with Robotics, Software, Operations, and Science teams.

The VP Engineering will bring deep technical experience in automation of lab science, a track record of building and leading multi-disciplinary engineering organizations, mentorship practices that foster career development of engineers at all levels, and the judgment to balance near-term delivery with long-term platform development. This is a hands-on leadership role in a fast-moving environment, requiring brilliance and dynamism to realize autonomous experimentation across materials science, chemistry, and life science. The role requires engineering innovations to achieve an unprecedented depth of AI integration in lab science, which combined with aggressive scaling of Lila’s AI Science Factories (AISFs) will produce the highest degree of scientific intelligence on earth.

What You'll Be Building

• Set the engineering roadmap for ASP Engineering, including objectives, risks, and platform priorities via collaboration with the Robotics, Software, Science, and Product teams.
• Define and drive a unified platform architecture across hardware, automation, and systems engineering, reducing one-off designs and enabling repeatable system deployment across sites
• Establish system-level ownership of architecture, interfaces, and requirements to ensure consistent integration across all engineering domains
• Implement efficient processes for lifecycle, design controls, safety and compliance, change management, and deployment of autonomous laboratories to support rapid scaling without compromising system consistency
• Develop a repeatable deployment model for standing up global AI Science Factory sites with predictable performance and reliability
• Create a culture of mentorship that supports execution of the roadmap while fostering career development of engineers
• Partner with Robotics and Software to build, industrialize, and scale all-of-science autonomous labs with a focus on reliability, throughput, and quality
• Integrate AI into the engineering lifecycle to bolster engineering speed and quality, decision making, and continuous improvement
• Collaborate with Talent Acquisition to establish hiring practices that accelerate identification and onboarding of brilliant, culturally-aligned engineers
• Partner with AI Research, Software, Product, and Science to align platform capabilities with scientific and commercial priorities
• Develop and communicate clear prioritization frameworks across engineering initiatives; translate organizational feedback into actionable systems and process improvements
• Represent Engineering with executive stakeholders and external partners; communicate tradeoffs, progress, and impact clearly
• Partnering with external integrators, OEMs, and contractors to expand engineering capacity

What You’ll Need to Succeed

• 15+ years building lab automation systems
• 10+ years leading managers and multi-disciplinary teams at scale
• Proven track record scaling automated labs or manufacturing-like lab operations, including instrument and robot integration, scheduling and orchestration, reliability engineering, and capacity planning
• Demonstrated experience integrating AI/ML into engineering, operations, and/or research environments
• Experience building and standardizing complex engineering systems from early-stage, project-based environments into scalable, repeatable platforms
• Demonstrated ability to balance rapid experimentation with the introduction of structure required for scale
• Technical expertise across lab automation, controls/SCADA, and science instrumentation, including integration and co-development of robotics and software/data/compute platforms
• Strong people and org leadership: recruiting and developing exceptional managers and ICs; building inclusive, high-ownership cultures that scale
• Excellence in retaining cultural and technical excellence across multiple sites of lab automation innovation and build-outs

Bonus Points For

• Multi-domain engineering excellence (mechanical, controls, electrical, systems) and cross-discipline engineering fluency (robotics, software, computer)
• Experience defining interface standards across hardware, robotics, and software systems
• Experience standing up lifecycle management (e.g., PLM-lite, change control, commissioning frameworks) in fast-moving environments
• Multi-domain science fluency (materials science, chemistry, life science)
• 10+ years experience integrating LIMS, orchestration, schedulers, and reliability and observability pipelines in lab automation
• Experience managing stage-gate transitions from R&D to scaled operations across multiple sites

Liquid Personnel is seeking confident and dynamic Social Workers who are passionate about making a difference in their local community. If you are naturally curious, have an eye for detail, enjoy building strong relationships and love exploring new possibilities, we want to hear from you!

Our client currently has exciting vacancies in: Wisbech, Ely, Cambridge, Huntingdon.

What will your responsibilities be?

In this role, you will,

• Empower children, young people, and their families by promoting choice, control, and flexibility in managing their support needs.
• Ensure access to inclusive services that enable individuals to be active members of their community.
• Apply Person-Centred Planning approaches to understand and respect the views, wishes, and feelings of children, young people, and families.
• Build strong, trusting relationships with families and partner agencies to deliver high-quality, tailored support and achieve the best outcomes.
• Make a positive difference in the lives of children, young people, and their families through effective social work practice.
• Uphold high professional standards and demonstrate a commitment to continuous learning and development.
• Embrace the challenges of the Social Worker role with resilience and a solution-focused approach.
• Contribute to the ongoing reshaping of Children’s Services, supporting innovation and improvement in how we work.
• Ensure all interventions are child-centred, promoting safety, wellbeing, and inclusion.

Benefits:

• A comprehensive wellbeing package to cover all aspects of wellbeing, both in and out of work, which can also be accessed by your family
• 6 days of protected time each year to support in maintaining your Continuous Professional Development
• A relocation package of up to £8,000 (eligibility applies)
• A pay progression scheme to enable Social Workers to accelerate through the pay grade as you gain experience and skills
• Salary up to £43516
• Scalable retention payments of up to £8,147 (Social Worker) and £9,118 (Senior Practitioner) over a 3 year period, starting after your first full year of employment for staff in our Assessment, Family Support & Safeguarding and Corporate Parenting Teams
• A Refer a Friend Scheme where if you refer another Social Worker to us who is subsequently employed by us as a result of that introduction, we’ll pay you an introduction fee of £350
• Access to our Cambridgeshire Academy for Reaching Excellence (CARE) who will support your development, enabling you to become the best practitioner 
• Flexible working requests from day one of employment and so we are open to discussing different working patterns to help you bring your best self to work.

Qualifications & Experience:

We're looking for confident and dynamic individuals who enjoy making a difference in their local community, are curious and spot things that others might not see, enjoys building relationships and likes to explore possibilities.

• Social Work England registration
• Eligible to work in the UK
• Hold a full UK driving licence
• Post-qualified experience
• Degree level or equivalent in Social Work
• Have the ability to work from a variety of locations and travel countywide independently.

Reasonable Adjustments:

If you consider yourself to have a disability or require any reasonable adjustment during the recruitment process or within the workplace, please highlight this at the earliest opportunity by contacting our team. With this information, we will provide appropriate support to you throughout the process and into your work placement.

We are unable to support or accept applications from candidates who are residents within the Red or Amber list of the Code of practice for the international recruitment of health and social care personnel in England, based on the World Health Organisation (WHO) Workforce Support and Safeguard List.

BH - 195999
GH - 33891

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines (PM), an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

Position Summary:

We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This is a senior leadership role operating at the intersection of science, strategy, and operations—requiring the ability to set direction across a complex multimodality pipeline, and build CMC function as a competitive advantage for Pioneering Medicines. This position reports to the SVP, CMC & Technical Operations.

This role will serve as the strategic and operational owner of CMC across the full PM portfolio from research interface through early and late clinical development. This leader will be equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level. They will define how PM approaches emerging modalities, build and leverage a best-in-class external Contract Development and Manufacturing Organizations (CDMO) network, combined with the strategic acumen to make portfolio-level resourcing decisions. They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Responsibilities:

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement
• Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation
• Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs
• Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio
• Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross-functional trade-offs, and ensure portfolio decisions reflect both scientific rigor and operational reality
• Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed
• Serves as an ambassador of PM for external stakeholders and industry as a whole

Requirements:

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
• Deep hands-on expertise in small molecules and biologics. Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies
• Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
• Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines
• Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites
• Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches to elevate program / portfolio value
• Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
• Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
• Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
• Entrepreneurial builder energized by creating structure in ambiguous, fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
• Collaborative, low-ego leadership style with genuine investment in team development and cross-functional relationships

About Flagship 

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond. 
 
What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. 
 
 Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture. Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company’s annual list of the World’s Most Innovative Companies. 

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. 

The salary range for this role is $228,000 - $313,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.

Title:                   Contract - Senior Quality Control Specialist

Location:           Cambridge, MA - onsite

Reports to:        Senior Manager, Quality Control

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

This position directly supports Vedanta’s in-house cGMP manufacturing capabilities. This role will be lab-centered and focused on Drug Product and Drug Substance testing for release and stability. In addition to performing testing, this role will participate in the management of the Quality Control laboratory with daily responsibilities including routine lab testing, inventory management, and data reporting.

There will be collaboration with Analytical Development, Quality Assurance, and Production departments to support cGMP manufacturing, Process Validations, and Analytical Testing Validations.

A successful candidate for this role will have strong attention to detail, good organizational skills, and be a quick learner. They will be able to exercise judgment within defined procedures and practices to determine appropriate action and ask questions if the path forward is unclear, follow routine procedures, apply learned techniques, and contribute to analysis and investigation to solve problems. An ideal candidate will be a strong independent worker, able to self-organize and execute day-to-day work autonomously.

Previous experience with hands-on laboratory testing in a microbiology laboratory, aseptic technique, qPCR, pipetting, and general USP microbiological is required. Experience with chemistry testing and data review preferred.

This role will require being on-site full-time in Cambridge.

Here’s What You’ll Do:

• Perform routine microbiology testing to support release and stability of Vedanta products
• Perform testing to support assay validation activities
• Review test lab data, protocols, reports, and quality events (deviations, OOS etc.)
• Author, review, and revise SOPs, protocols, and reports
• Participate in continuous improvement projects to support the growth of the company
• Participate within the QC team to meet group and company goals

Requirements:

• BS in a scientific discipline
• Minimum 5+ years working in a GMP environment and/or Quality Control test lab
• Direct, hands on, experience with PCR/qPCR testing
• Direct experience with aseptic sampling and testing techniques
• Strong laboratory and organizational skills, attention to detail, flexibility, and the ability to work independently and within a team environment
• Experience working within QMS systems, deviation investigations, OOS, CAPAs and Change Controls
• Experience with QC continuous improvement projects; project management skills a plus
• Proficient in Outlook, MS Word, Excel, and lab-based data management systems
• Knowledge of FDA and EU compliance principles
• Knowledge of USP and ICH guidance preferred

The base pay range for this position is expected to be $46-53 per hour; however, the base pay offered may vary depending on market dynamics, experience, internal equity, and job-related knowledge, skills, and capabilities.

Our Opportunity…

We are looking for a strategic and hands-on Associate Director, IT Operations to lead and optimize Digital Solutions & Technology operations at Obsidian, delivering secure, compliant, and scalable technology services that enable our clinical-stage biotech teams to achieve breakthrough scientific and business outcomes.

You Will...

• Develop and execute Digital Solutions & Technology operations strategy aligned with Obsidian’s growth, compliance needs, and culture. 
• Lead day-to-day operations, including infrastructure, cloud environments, enterprise systems, and lab/scientific software. 
• Manage MSP resources, ensuring high-quality support and service levels. 
• Partner with Info Security lead to ensure robust cybersecurity and data protection. 
• Optimize Digital Solutions & Technology processes (incident, problem, change management) and drive adoption of best practices, with a strong emphasis on ITIL and change management in a controlled, regulated environment. 
• Manage vendor relationships and operations budget. 
• Support onboarding/offboarding, access management, and end-user training. 
• Foster a culture of accountability, collaboration, and continuous improvement. 
• Risk Management & Business Continuity: Identify, assess, and mitigate IT risks; develop and maintain business continuity and disaster recovery plans. 
• Work closely with Facilities, Lab Operations, and other business units to ensure Digital Solutions meet evolving scientific and operational needs. 
• Continuous Improvement & Innovation: Drive process optimization and adoption of new technologies to improve service delivery and operational efficiency. 
• KPIs & Metrics: Define, track, and report on IT operational KPIs (e.g., uptime, ticket resolution, user satisfaction, compliance metrics). 
• Regulatory Audit Readiness: Prepare for and support regulatory audits (FDA, SOX, etc.), ensuring documentation and processes are audit-ready. 

Key Systems & Platforms 

• Networking: Cisco Meraki, Fortinet 
• Scientific/Lab: Benchling, Egnyte 
• HR: ADP, Greenhouse, Pave 
• Finance: NetSuite, FloQast, Concur 
• Business Development: DataSite DataRooms 
• Enterprise: M365, Adobe, Teams, Teams Room Systems 
• Ticketing: Freshdesk 
• Compliance: ComplianceWire, validated SharePoint 

 You Bring...

Core Qualifications

• Bachelor's degree in computer science, Information Technology, or related field with 10+ years of relevant IT experience, including leadership of IT operations in a regulated environment (biotech, pharma, or healthcare preferred). 
• Experience with IT operations in agile, fast-growing companies. 
• Experience with GxP systems operational support (CSV/CSA). 
• Experience with change control systems and processes for GxP/SOX. 
• Experience managing MSPs and IT service delivery across multiple locations. 
• Strong knowledge of enterprise platforms (NetSuite, M365, ADP, Benchling, etc.) and lab/scientific software. 
• Experience managing Lab IT systems 
• Excellent planning, coordination, and time management skills. 
• Strong oral, written, and visual communication skills. 
• Ability to build productive relationships across scientific, business, and technical teams. 
• Systems thinking and sound judgment, especially in risk management and escalation 
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes 
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.   
• Flexible - adapts to change in a fast paced, rapidly developing environment 
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner 
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments  

About Dimagi

Dimagi is an award-winning social enterprise and a certified B-corp and Benefit Corporation. We build software solutions and provide technology consulting services to improve the quality of essential services for underserved populations. Our open-source technology platform, CommCare, is the world’s most widely-used and researched mobile data collection platform for frontline workers. Our choice to be a certified B-Corp and to legally incorporate as a Benefit Corporation sends a clear signal to our partners, our team members, and our communities that we not only believe but also take action in using business as a force for good. This approach combines our passion and commitment to tackle complex health and social inequities and work towards a brighter future for all.

About the Position

Dimagi is looking for a Data Engineer II to join our US Solutions Division. This position will be affiliated with our Cambridge, MA office but is open to remote employment within the United States. This is a 12-month fixed-term position with the possibility of renewal based on business requirements and mutual interest. 

The Data Engineer II will be part of Dimagi’s US Solutions Division Data & Analytics team, a group of engineers and data specialists responsible for building, maintaining, and evolving Dimagi’s Data Platform in support of current and future project work. The primary technologies used by the current data platform are Snowflake, Tableau, and various AWS cloud tools. In this role, you will contribute hands-on to the design, implementation, and operation of data pipelines, warehouse transformations, data visualizations, and supporting infrastructure, while working closely with technical leadership to ensure platform reliability, scalability, and alignment with business needs. The data systems you help build and maintain will directly support public health and human services programs, enabling frontline teams and government partners to deliver care and services more effectively.

This position is well suited for someone who enjoys hands-on technical work in a small, collaborative environment. As a member of a lean team, you will be expected to work across functional areas, adapt quickly to new problem spaces, and contribute meaningfully to data systems that support real-world service delivery and decision-making.  This role assumes comfort using AI-assisted tools to support analysis, documentation, troubleshooting, and learning in a complex technical environment.

Responsibilities 

• Contribute to the technical integrity and evolution of the Data Platform tech stack, working closely with other Data Engineers, the Director of Technology, and the USS Tech Lead.
• Design and implement core features and enhancements within the Data Platform, including contributing to technical specifications, conducting targeted technical research, and translating requirements into production-ready solutions.
• Responsible for executing and maintaining DevOps workflows supporting the Data Platform, including performance monitoring, platform upgrades, deployment frameworks, and operational improvements, with guidance and mentorship from more senior Data Engineers as needed.
• Use AI-assisted tools thoughtfully to accelerate development, debugging, documentation, and operational analysis, while understanding and validating outputs to ensure correctness, reliability, and security.
• Build and maintain robust data extraction, loading, and transformation processes for both Dimagi managed (i.e. CommCare) and external data sources, enabling efficient, reliable data pipelines and their long-term development and operation using both SQL and Python scripting.
• Design and develop data warehouse transformations, using SQL-based approaches and supplementary tools such as dbt.
• Collaborate with internal teams and external partners on the design and implementation of enterprise data architectures based on industry standards and partner specific analytics needs.
• Conduct ad hoc analyses and support the development of business intelligence outputs, including dashboards and visualizations using Tableau and other tools.

The ideal candidate will have some or all of the following experience:

• 2–5 years of experience in data engineering or a similar technical role, with a proven track record of designing and evolving scalable data systems.
• Experience building maintainable, long-term technical solutions using software development best practices (version control, testing, and iterative development).
• Hands-on expertise in building and managing production-grade pipelines using ETL/ELT tools (e.g., dbt, Airflow, Prefect, Fivetran, or Talend).
• Strong proficiency with cloud-based data platforms (AWS, Snowflake, etc.) and a diverse range of data ingestion, processing, and storage technologies.
• Expert-level SQL for complex data engineering and analysis, paired with proficiency in Python and associated data-oriented toolkits.
• A deep understanding of dimensional modeling concepts ((e.g. OLAP cubes, star schemas, kimball architecture vs. alternatives like inmon)
• Proven ability to partner with technical stakeholders to clarify requirements and deliver effective, end-to-end data solutions.
• Proficiency in using AI-assisted tools for code generation, debugging, and optimization, with the ability to rapidly adapt to new schemas and tools in a fast-paced environment.
• Comfortable working "in the trenches" of production systems to test, iterate, and optimize operational workflows.
• Eligible to work in the United States

Bonus Experience

• Experience in enterprise data architecture, service-oriented frameworks, data integration and harmonization, data strategy and governance, high-performing data lakes, data operations and delivery and data ingestion frameworks supporting batch/real-time
• Experience writing and maintaining production ready code in a high level programming language (Python, Java, C++ etc.)
• Experience with data analysis software (Jupyter Notebooks, R, etc.) and data visualization tools (Tableau, Power BI, Superset, etc.). 
• Healthcare experience: either in healthcare data or public health data collection methodologies and workflows
• Experience and comfort working independently with partners for requirements gathering and solution development in an agile software development environment, using JIRA and Asana to manage tasks between technical and client-facing teams

Benefits and Compensation

We aim to make a difference, not just as a company but also as an employer! We are transparent about salaries at all levels of the organization and have a standard, global pay scale for all positions. Our salaries are cost of living adjusted and non-negotiable. The estimated salary range for this position is 82,810 USD - 130,319 USD annually. Your final salary within the range will be dependent on where you are geographically based and might fall outside of this estimated range.

However, the benefits we offer are geared towards having a strong impact on our staff’s well-being. A few of our key benefits are outlined below:

• 100% employer-sponsored medical insurance paired with a generous Health Reimbursement Account (HRA) fund
• Access to voluntary dental and vision insurance plans
• A 401K plan with up to a 4% employer match
• Employee stock option plan
• 30 days paid time off inclusive of holidays
• Unlimited sick time and excellent parental leave policy
• Access to a flex-time policy that allows employees to work based on a flexible work schedule
• Access to an Employee Assistance Program (EAP) through ComPsych

Dimagi is an Equal Opportunity Employer. We celebrate and support diversity and are committed to providing a work environment that is inclusive and free of discrimination and harassment. All employment decisions are based on individual qualifications without regard to race, color, religion, age, sex, sexual orientation, ethnicity, gender identity and expression, national origin, family or parental status, veteran or disability status.

ABOUT PIONEERING INTELLIGENCE 

Pioneering Intelligence builds on Flagship Pioneering’s legacy of founding cutting-edge science and computational ventures, harnessing recent advances in AI, machine learning, and data to accelerate fundamental research and create a portfolio of AI-first companies. As part of Flagship’s integrated model of science, entrepreneurship, and capital, it transforms breakthrough ideas into world-changing companies, elevating the AI advances happening across the ecosystem in human health, sustainability, and beyond.

THE ROLE

We are seeking a Principal Scientist (Embedded ML/Computational) to lead multiple AI/ML or computational projects across early stage ventures, as a part of Flagship’s company origination process. You will define and deliver pragmatic AI strategies, oversee method and platform development (e.g., systems design, drug design, molecular modeling, systems biology, protein design, LLM/agentic workflows), and ensure rigor in model development, benchmarking, scaling, and reporting. You will manage cross functional contributors as applicable, influence company direction, and represent PI to venture teams and external partners. The ideal candidate is a self-directed serial deep diver - someone who can move from protein design one week to mass spec or docking pipelines the next and then spin up LLM based agents that automate scientific workflows. 

KEY RESPONSIBILITIES

• Program Leadership: Lead development, implementation, control, and reporting of several AI/ML or computational projects within assigned ventures in line with broader strategic plans of PI and Flagship, budgets, and timelines. 
• Technical Ownership: Take a specialized technical role on project teams to oversee method development, pipeline development, and LLM based agent/workflow design; drive benchmarking, scaling, and implementation into production grade systems. 
• Best Practices: promote operational excellence in AI projects by educating cross-functional collaborators. 
• Team Leadership: Manage and/or coordinate internal and external scientists/engineers and crossfunctional project teams as applicable; mentor early hires; support recruiting and interview. 
• Planning & Resourcing: Contribute to project planning, including budgets, resources, and timelines; surface risks and tradeoffs early with clear options. 
• Landscape & Strategy: Independently scout emerging literature and the AI/ML landscape; synthesize concepts to propose new development strategies and identify opportunities for PI and venture portfolios. 
• Representation & Community: Represent PI to portfolio companies and external partners; act as a recognized subject matter expert; actively participate in scientific conferences and meetings. 
• Communication & Influence: Influence the course of projects and technical approaches; adapt and present complex findings to diverse audiences to support meaningful interpretation and action. 

PROFESSIONAL EXPERIENCE & QUALIFICATIONS 

• Master’s, or PhD in a relevant field (e.g., machine learning, mathematics, statistics, computational sciences) with 5+ years' experience scientific/engineering/computational in academic, pharmaceutical, or biotechnology settings; industry AI/ML experience preferred. 
• Experience driving results directly or indirectly through teams of engineers/scientists in dynamic, fastpaced, entrepreneurial, and technical environments. 
• Clear evidence of sustained independent thought and creativity driving high impact, cross disciplinary AI/ML projects. 
• Successful track record of leadership and contribution to decision making on progression of AI/ML models within projects or programs. 
• Depth across multiple core tools and concepts, including Python; modern ML frameworks (PyTorch or JAX/TensorFlow); version control; databases; deep learning architectures; and relevant informatics software. 
• Consistent record of outstanding performance reflected in publications, patents, or high impact internal reports where applicable 

Preferred Qualifications 

• Breadth across domains such as protein modeling/design, proteomics/mass spec, cheminformatics/docking/ADMET, biophysics/MD, and LLM/agentic automation. 
• MLOps expertise: data contracts and lineage (e.g., DVC/LakeFS), experiment tracking (MLflow/W&B), secure AWS infrastructure (S3, Batch/ECS/EKS, SageMaker), Docker, IaC (Terraform/CDK), and CI/CD (GitHub Actions). 
• Generative modeling (diffusion/flow/VAEs) for sequences, graphs, or 3D structures; docking rescoring (e.g., gnina, DiffDock) and pose quality metrics. 
• Workflow orchestration (Airflow/Prefect/Argo), data warehouses (Redshift/Snowflake), vector search (FAISS/pgvector), and lightweight internal tools (FastAPI, Streamlit/Gradio). 
• Experience mentoring early hires, acting as interim Head of ML, and contributing to hiring plans and interview processes at startups. 

WHY PIONEERING INTELLIGENCE

• Operate at the frontier: Build and deploy AI/ML that directly powers discovery and decision making across multiple new ventures. 
• Own the full stack: From scoping and data contracts to models, MLOps, and internal UIs—ship endtoend systems that scientists rely on daily. 
• Compound impact: Convert one off wins into shared libraries and templates adopted across the PI portfolio. 
• Work with founders: Partner closely with venture leadership and PI platform engineers; influence strategy through hands on delivery. 
• Grow fast: Stretch across domains, take on situational leadership, present at conferences, and help shape first ML teams. 

ABOUT FLAGSHIP PIONEERING:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

#LI-MB1

The salary range for this role is $208,000 - $286,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Intelligence currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Intelligence’s good faith estimate as of the date of publication and may be modified in the future.

ABOUT PIONEERING INTELLIGENCE 

Pioneering Intelligence builds on Flagship Pioneering’s legacy of founding cutting-edge science and computational ventures, harnessing recent advances in AI, machine learning, and data to accelerate fundamental research and create a portfolio of AI-first companies. As part of Flagship’s integrated model of science, entrepreneurship, and capital, it transforms breakthrough ideas into world-changing companies, elevating the AI advances happening across the ecosystem in human health, sustainability, and beyond.

THE ROLE

We are seeking a Principal Scientist (Embedded ML/Computational) to lead multiple AI/ML or computational projects across early stage ventures, as a part of Flagship’s company origination process. You will define and deliver pragmatic AI strategies, oversee method and platform development (e.g., systems design, drug design, molecular modeling, systems biology, protein design, LLM/agentic workflows), and ensure rigor in model development, benchmarking, scaling, and reporting. You will manage cross functional contributors as applicable, influence company direction, and represent PI to venture teams and external partners. The ideal candidate is a self-directed serial deep diver - someone who can move from protein design one week to mass spec or docking pipelines the next and then spin up LLM based agents that automate scientific workflows. 

KEY RESPONSIBILITIES

• Program Leadership: Lead development, implementation, control, and reporting of several AI/ML or computational projects within assigned ventures in line with broader strategic plans of PI and Flagship, budgets, and timelines. 
• Technical Ownership: Take a specialized technical role on project teams to oversee method development, pipeline development, and LLM based agent/workflow design; drive benchmarking, scaling, and implementation into production grade systems. 
• Best Practices: promote operational excellence in AI projects by educating cross-functional collaborators. 
• Team Leadership: Manage and/or coordinate internal and external scientists/engineers and crossfunctional project teams as applicable; mentor early hires; support recruiting and interview. 
• Planning & Resourcing: Contribute to project planning, including budgets, resources, and timelines; surface risks and tradeoffs early with clear options. 
• Landscape & Strategy: Independently scout emerging literature and the AI/ML landscape; synthesize concepts to propose new development strategies and identify opportunities for PI and venture portfolios. 
• Representation & Community: Represent PI to portfolio companies and external partners; act as a recognized subject matter expert; actively participate in scientific conferences and meetings. 
• Communication & Influence: Influence the course of projects and technical approaches; adapt and present complex findings to diverse audiences to support meaningful interpretation and action. 

PROFESSIONAL EXPERIENCE & QUALIFICATIONS 

• Master’s, or PhD in a relevant field (e.g., machine learning, mathematics, statistics, computational sciences) with 5+ years' experience scientific/engineering/computational in academic, pharmaceutical, or biotechnology settings; industry AI/ML experience preferred. 
• Experience driving results directly or indirectly through teams of engineers/scientists in dynamic, fastpaced, entrepreneurial, and technical environments. 
• Clear evidence of sustained independent thought and creativity driving high impact, cross disciplinary AI/ML projects. 
• Successful track record of leadership and contribution to decision making on progression of AI/ML models within projects or programs. 
• Depth across multiple core tools and concepts, including Python; modern ML frameworks (PyTorch or JAX/TensorFlow); version control; databases; deep learning architectures; and relevant informatics software. 
• Consistent record of outstanding performance reflected in publications, patents, or high impact internal reports where applicable 

Preferred Qualifications 

• Breadth across domains such as protein modeling/design, proteomics/mass spec, cheminformatics/docking/ADMET, biophysics/MD, and LLM/agentic automation. 
• MLOps expertise: data contracts and lineage (e.g., DVC/LakeFS), experiment tracking (MLflow/W&B), secure AWS infrastructure (S3, Batch/ECS/EKS, SageMaker), Docker, IaC (Terraform/CDK), and CI/CD (GitHub Actions). 
• Generative modeling (diffusion/flow/VAEs) for sequences, graphs, or 3D structures; docking rescoring (e.g., gnina, DiffDock) and pose quality metrics. 
• Workflow orchestration (Airflow/Prefect/Argo), data warehouses (Redshift/Snowflake), vector search (FAISS/pgvector), and lightweight internal tools (FastAPI, Streamlit/Gradio). 
• Experience mentoring early hires, acting as interim Head of ML, and contributing to hiring plans and interview processes at startups. 

WHY PIONEERING INTELLIGENCE

• Operate at the frontier: Build and deploy AI/ML that directly powers discovery and decision making across multiple new ventures. 
• Own the full stack: From scoping and data contracts to models, MLOps, and internal UIs—ship endtoend systems that scientists rely on daily. 
• Compound impact: Convert one off wins into shared libraries and templates adopted across the PI portfolio. 
• Work with founders: Partner closely with venture leadership and PI platform engineers; influence strategy through hands on delivery. 
• Grow fast: Stretch across domains, take on situational leadership, present at conferences, and help shape first ML teams. 

ABOUT FLAGSHIP PIONEERING:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

#LI-MB1

The salary range for this role is $208,000 - $286,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Intelligence currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Intelligence’s good faith estimate as of the date of publication and may be modified in the future.

ABOUT PIONEERING INTELLIGENCE 

Pioneering Intelligence builds on Flagship Pioneering’s legacy of founding cutting-edge science and computational ventures, harnessing recent advances in AI, machine learning, and data to accelerate fundamental research and create a portfolio of AI-first companies. As part of Flagship’s integrated model of science, entrepreneurship, and capital, it transforms breakthrough ideas into world-changing companies, elevating the AI advances happening across the ecosystem in human health, sustainability, and beyond.

THE ROLE

We are seeking a Principal Scientist (Embedded ML/Computational) to lead multiple AI/ML or computational projects across early stage ventures, as a part of Flagship’s company origination process. You will define and deliver pragmatic AI strategies, oversee method and platform development (e.g., systems design, drug design, molecular modeling, systems biology, protein design, LLM/agentic workflows), and ensure rigor in model development, benchmarking, scaling, and reporting. You will manage cross functional contributors as applicable, influence company direction, and represent PI to venture teams and external partners. The ideal candidate is a self-directed serial deep diver - someone who can move from protein design one week to mass spec or docking pipelines the next and then spin up LLM based agents that automate scientific workflows. 

KEY RESPONSIBILITIES

• Program Leadership: Lead development, implementation, control, and reporting of several AI/ML or computational projects within assigned ventures in line with broader strategic plans of PI and Flagship, budgets, and timelines. 
• Technical Ownership: Take a specialized technical role on project teams to oversee method development, pipeline development, and LLM based agent/workflow design; drive benchmarking, scaling, and implementation into production grade systems. 
• Best Practices: promote operational excellence in AI projects by educating cross-functional collaborators. 
• Team Leadership: Manage and/or coordinate internal and external scientists/engineers and crossfunctional project teams as applicable; mentor early hires; support recruiting and interview. 
• Planning & Resourcing: Contribute to project planning, including budgets, resources, and timelines; surface risks and tradeoffs early with clear options. 
• Landscape & Strategy: Independently scout emerging literature and the AI/ML landscape; synthesize concepts to propose new development strategies and identify opportunities for PI and venture portfolios. 
• Representation & Community: Represent PI to portfolio companies and external partners; act as a recognized subject matter expert; actively participate in scientific conferences and meetings. 
• Communication & Influence: Influence the course of projects and technical approaches; adapt and present complex findings to diverse audiences to support meaningful interpretation and action. 

PROFESSIONAL EXPERIENCE & QUALIFICATIONS 

• Master’s, or PhD in a relevant field (e.g., machine learning, mathematics, statistics, computational sciences) with 5+ years' experience scientific/engineering/computational in academic, pharmaceutical, or biotechnology settings; industry AI/ML experience preferred. 
• Experience driving results directly or indirectly through teams of engineers/scientists in dynamic, fastpaced, entrepreneurial, and technical environments. 
• Clear evidence of sustained independent thought and creativity driving high impact, cross disciplinary AI/ML projects. 
• Successful track record of leadership and contribution to decision making on progression of AI/ML models within projects or programs. 
• Depth across multiple core tools and concepts, including Python; modern ML frameworks (PyTorch or JAX/TensorFlow); version control; databases; deep learning architectures; and relevant informatics software. 
• Consistent record of outstanding performance reflected in publications, patents, or high impact internal reports where applicable 

Preferred Qualifications 

• Breadth across domains such as protein modeling/design, proteomics/mass spec, cheminformatics/docking/ADMET, biophysics/MD, and LLM/agentic automation. 
• MLOps expertise: data contracts and lineage (e.g., DVC/LakeFS), experiment tracking (MLflow/W&B), secure AWS infrastructure (S3, Batch/ECS/EKS, SageMaker), Docker, IaC (Terraform/CDK), and CI/CD (GitHub Actions). 
• Generative modeling (diffusion/flow/VAEs) for sequences, graphs, or 3D structures; docking rescoring (e.g., gnina, DiffDock) and pose quality metrics. 
• Workflow orchestration (Airflow/Prefect/Argo), data warehouses (Redshift/Snowflake), vector search (FAISS/pgvector), and lightweight internal tools (FastAPI, Streamlit/Gradio). 
• Experience mentoring early hires, acting as interim Head of ML, and contributing to hiring plans and interview processes at startups. 

WHY PIONEERING INTELLIGENCE

• Operate at the frontier: Build and deploy AI/ML that directly powers discovery and decision making across multiple new ventures. 
• Own the full stack: From scoping and data contracts to models, MLOps, and internal UIs—ship endtoend systems that scientists rely on daily. 
• Compound impact: Convert one off wins into shared libraries and templates adopted across the PI portfolio. 
• Work with founders: Partner closely with venture leadership and PI platform engineers; influence strategy through hands on delivery. 
• Grow fast: Stretch across domains, take on situational leadership, present at conferences, and help shape first ML teams. 

ABOUT FLAGSHIP PIONEERING:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

#LI-MB1

The salary range for this role is $208,000 - $286,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Intelligence currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Intelligence’s good faith estimate as of the date of publication and may be modified in the future.

Our Opportunity...

We are looking for a highly motivated Associate Director of Data Management. As a key contributor within the Clinical Operations team, you’ll be responsible for leading the entire data lifecycle at the program level for development of our first clinical stage autologous cell therapy program targeting solid tumors. 

You will be responsible from study startup to database lock for multiple clinical studies developing engineered TIL cell therapies for certain solid tumor indications, oversee end-to-end clinical data strategy, ensuring high-quality, regulatory-compliant data (e.g., SDTM/CDISC) from study startup to lock. 

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.  

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

This is a Hybrid role based out of Bedford or Cambridge, MA locations.  

You Will...

Core responsibilities

• Manage all clinical data management (CDM) activities, serving as the primary point of contact for CROs and vendors, ensuring studies are delivered on time, within budget, and in compliance with ICH-GCP  
• Actively represent Data Management in study team meetings, leadership forums, and regulatory audits 
• Provide expertise in database setup, CRF design, and development of data management strategy to ensure high-quality, submission-ready data  
• Develop data management plans (DMPs) and provide technical guidance on clinical database structures to internal teams and external partners  
• Ensure all clinical data, including AE and SAE data, complies with CDISC standards (CDASH/SDTM) and is prepared for FDA and EMA submissions  
• Oversee data cleaning, discrepancy management, and reconciliation of third-party data sources (e.g., central labs, IRT)  
• Collaborate with Programming to implement internal data quality checks and support ongoing data review activities  
• Partner with Clinical Operations, Biostatistics, Medical Monitoring, and Regulatory Affairs to define data standards, assess data quality, and resolve queries  
• Ensure integration of data across clinical and manufacturing systems, including specialized tracking such as scalpel-to-vein processes for TIL therapy  
• Manage vendors and ensure appropriate resourcing to support clinical trial execution  
• Coordinate CDM deliverables across internal and external cross-functional teams  
• Collaborate with Supply Chain and Logistics to oversee tracking of manufacturing data  
• Work with Standards, Quality, and Compliance teams to develop and implement data standards and drive continuous process improvement  
• Develop and refine standard operating procedures (SOPs)  
• Apply strong project management, organizational, and interpersonal skills to support successful study execution 
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes  
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments 

You Bring...

Core Qualifications

• Education: Bachelor's Degree in life sciences, mathematics, or related field; with 10+ years of progressive experience in a biopharma setting, or a master's degree with 8+ (Master’s preferred). 
• Experience: 6 - 8+ years of experience in clinical data management, including significant experience in oncology, and ideally in cell therapy. 
• Systems: Proficiency in electronic data capture (EDC) systems, particularly Medidata Rave. 
• Technical Knowledge: Strong understanding of CDISC, SDTM, CDASH, and ICH-GCP regulations. 
• Leadership: Proven ability to manage CROs and lead cross-functional teams. 
• Excellent planning, coordination, and time management skills   
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   
• Ability to build and maintain productive relationships with colleagues within the clinical team, across the Obsidian organization, and with external partners.   

Position Overview:

Beam is seeking a dynamic, visionary, and strategic Senior Director, Global HEOR to spearhead the global HEOR strategy for our sickle cell disease program (risto-cel) and other pipeline programs as they emerge . In this high-impact role, the Senior Director, Global HEOR will develop and execute evidence-generation plans, manage stakeholder relationships, and shape external communication strategies. You will partner closely with Clinical Development, Medical Communications and Scientific Publications, Value and Evidence Strategy, Commercial, R&D, and additional cross-functional teams. If you thrive in a collaborative, mission-driven environment and are eager to shape the future of sickle cell disease care, we want you to bring your expertise and passion to Beam.

Responsibilities:

• Provide strategic input to disease prioritization, target product profiles, clinical trial protocols, clinical development plans, and regulatory submissions; lead development of clinical sections for Investigator’s Brochures, briefing books, safety updates, IND/NDA materials, and responses to Health Authority questions. 
• Develop, validate, and integrate patient‑centered outcomes (PROs) into protocols and analyses.
• Interpret clinical trial results (including PROs and healthcare resource use) and partner with Clinical Development/Biostatistics on Statistical Analysis Plans (SAPs) and post‑hoc analyses.
• Lead a fit‑for‑purpose RWE strategy (EHR, claims, registries, hybrid/open datasets) including natural history/registry design and governance to inform endpoints, recruitment, and post‑authorization effectiveness/safety assessments.
• Develop and operationalize external/synthetic control arm approaches (e.g., matched registry cohorts, Bayesian borrowing) for single‑arm or small‑population studies typical in cell & gene therapy.
• Provide operational oversight of Medical Affairs evidence generation, including vendor/CRO governance, milestone/deliverable tracking, data‑quality plans, risk management, and on‑time execution across Medical Affairs–led studies; contribute to long‑term capability building (digital health, real‑world studies).
• Elicit and integrate perspectives from patients, KOLs, policy leaders, and internal stakeholders (market access, marketing, patient advocacy) to ensure plans meet the needs of patients, HCPs, and payers.
• Support Market Access on internal and external payer/policy initiatives (pricing and reimbursement, unmet medical need, regional market dynamics, evidence gaps) across the portfolio.
• Support business decisions around ex-US strategy including, but not limited to, scoping ex-US opportunities, prioritizing country engagement, early scientific advice / parallel consultations with EMA and HTA bodies (e.g., HTACG/JSC), providing advice to development programs on endpoint selection to support product and reimbursement approvals ex-US, etc. 
• Anticipate payer evidence needs and budget‑impact critiques (including preparation for ICER Reviews). 
• Build and maintain economic models (cost‑effectiveness, budget impact) tailored to one‑time CGTs, addressing uncertainty/durability and caregiver burden. 
• Collaborate with Market Access to design innovative payment models and outcomes‑based agreements with pragmatic outcomes and tracking. 
• Lead the AMCP dossier and pre‑approval information exchange (PIE) strategy (6–12 months pre‑launch). 
• Work collaboratively with internal teams, consultants, and CROs to advance development of the portfolio. 

Qualifications:

• Master’s Degree or higher in Health Economics and Outcomes Research or a relevant discipline.
• Formal training in Epidemiology/Health Services Research required.
• At least 10+ years’ experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm.
• Proven track record in drug development, with rare disease experience and an existing network of hematologists preferred.
• Demonstrated ability to lead in a matrixed, cross-functional environment, combining strategic agility with strong business acumen.
• Independent, proactive operator with strong ownership.
• Cross functional collaboration with Clinical, Regulatory, Commercial, Medical Operations, and Publications while maintaining medical/scientific integrity.
• Excellent communication, collaboration, and problem-solving skills.
• #LI-Hybrid 

Position Overview:

The Senior Director, Global Logistics, Warehousing and Trade Compliance is responsible for defining and executing the global strategy, operational leadership, and compliant storage and movement of materials supporting R&D, Clinical, and Commercial programs across Beam. This role provides end‑to‑end leadership across global logistics operations, warehousing networks, and trade compliance, ensuring reliable supply, regulatory adherence, and scalable infrastructure to support pipeline growth and commercialization.

This position reports to the Vice President, Supply Chain and serves as a key member of the Supply Chain Leadership team, partnering closely with Technical Operations, Quality, R&D, Finance, Legal, Procurement, Clinical Patient Supply and Commercial Patient Operations.

Responsibilities:

• Global Logistics: Provides operational and strategic leadership for all R&D, Clinical, and Commercial shipments. Serves as subject matter expert for ambient, low‑temperature, and ultra‑low‑temperature cold chain systems, including shipping systems qualification and lane validation, in support of CMC development and commercialization. Supports Commercial Patient Operations for Risto-cel Patient shipments.
• Warehousing: Leads internal warehouse operations and the global 3PL network supporting storage, inventory management, kitting, and production support for critical raw materials, drug substance, and drug product. Ensures inventory accuracy, material availability, and scalable warehouse capabilities aligned with clinical and commercial demand.
• Trade Compliance: Acts as the enterprise risk leader for global trade compliance, ensuring compliance with international, federal, and state import/export laws and regulations. Leads the development and governance of compliant, efficient trade processes across North America, Europe, and Asia‑Pacific regions, and serves as the primary interface with customs brokers, government agencies, and external auditors. Champions a culture of compliance while enabling business agility and uninterrupted supply. Supports Market Access team for any commercial trade or channel distribution aspects.
• Strategy & Leadership:
  • Develop and execute global logistics, warehousing, and trade compliance strategy to support R&D, clinical trials, and commercial operations.
  • Establish long‑term vision for a flexible, scalable global distribution and storage network, aligned with Beam’s growth and commercialization plans.
  • Serve as a senior leader influencing enterprise and site‑level supply chain strategies, including readiness for new product launches and expansion of cell and gene therapy programs.
  • Build, lead, and develop high‑performing teams, fostering a strong talent pipeline, culture of accountability, and continuous improvement mindset.
• Logistics Operations
  • Provide operational leadership for global distribution, including domestic and international shipments from internal sites and external partners.
  • Lead shipping operations supporting R&D, clinical, and commercial programs, ensuring on‑time, in‑full delivery and patient‑centric execution.
  • Own cold chain strategy and execution, including qualification, validation, monitoring, and continuous improvement of shipping lanes and systems.
  • Ensure logistics operations comply with GMP, GDP, EHS, product security, and data integrity requirements.

• Warehousing & Inventory Management:
  • Lead internal and external warehousing operations, including inventory control, materials management, kitting, and production support.
  • Ensure no disruption to production schedules while proactively identifying and mitigating supply risks.
  • Drive inventory optimization, accuracy, and visibility across the network using ERP and digital tools.

• Trade Compliance & Governance
  • Create, lead, and chair the Trade Compliance Committee, ensuring adherence to all applicable global import/export laws, regulations, and guidance.
  • Develop and maintain a robust global import/export compliance framework, including permits, licenses, valuation, duties, VAT, sanctions, HTS classification, country of origin, and applicable Tariffs/Free trade agreements.
  • Serve as primary respondent to regulatory agency inquiries; investigate issues, develop corrective strategies, and ensure timely, compliant responses.
  • Lead duty savings and optimization strategies in collaboration with Finance and Supply Chain, while maintaining full regulatory compliance.

• Performance, Financial & Operational Excellence
  • Establish and monitor KPIs across logistics, warehousing, and trade compliance with clear, data‑driven reporting.
  • Manage operating budgets, capital expenditures, and cost optimization initiatives.
  • Drive automation, digitalization, and process improvements to enhance efficiency, scalability, and compliance.
  • Champion lean principles, continuous improvement, and right‑first‑time execution across the organization.

• Stakeholder & External Engagement
  • Build and maintain strong partnerships with Legal, Finance, Clinical, Commercial, Quality, Manufacturing, Procurement, IT, and HR.
  • Represent the company with customs authorities, regulatory agencies, industry groups, and external counsel as required.
  • Participate in global forums to influence policy, standardization, and best practices across the supply chain network.

Qualifications:

• Bachelor’s degree in Business, Supply Chain, Engineering, Life Sciences, or related field; MBA or Master’s degree preferred.
• 18+ years of progressive experience in global logistics, warehousing, supply chain, and/or trade compliance within biotech, pharmaceutical, or other highly regulated environments.
• Proven senior leadership experience managing complex global networks of internal operations and external partners (CMOs, CDMOs, 3PLs).
• Working knowledge of global trade compliance regulations, including U.S. Customs and relevant international authorities; experience with permits, licenses, duties, VAT, sanctions, and duty savings strategies.
• Demonstrated expertise in pharmaceutical cold chain logistics (ambient, refrigerated, frozen, ultra-low temperature) across R&D, clinical, and commercial programs.
• Strong strategic and operational leadership skills, with the ability to influence cross-functional and matrixed stakeholders globally.
• Excellent analytical, communication, and decision-making skills in high-complexity environments.
• Financial acumen including budgeting, cost control, and KPI management.
• Experience with ERP systems (SAP preferred) and electronic Quality Management Systems.
• Relevant certifications or formal trade compliance training are preferred (e.g., Customs, Export Compliance, APICS, HAZMAT).

Travel / On-site Requirements:

Up to 20% travel required to support internal sites, external partners, and global supply chain initiatives.

Onsite requirements: Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.

Company Overview 

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Analytical Chemistry function.

Description

Reporting to the Head of Technical Operations, the Director of Analytical Chemistry is responsible for the design and execution of the control strategies for the manufacture of drug substances and drug products for Fulcrum developmental programs.  In this position, the successful candidate will provide technical oversight of all Quality Control (QC) activities at DS and DP contract manufacturers. Additional responsibilities include collaborating with pharmaceutics on pre-formulation activities, collaborating with QA on OOS and OOT investigations and CMC risk management, and helping Reg-CMC author relevant sections of regulatory filings.

Key Responsibilities

• Provide technical leadership to CMOs and CROs for drug substance and drug product process development, including cGMP method development, validation, method transfer, method remediation, data analysis and reporting to ensure compliance with GCP, GLP and cGMP standards
• Collaborate with colleagues in Drug Substance, Drug Product, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
• Responsible for design and management of stability studies, including shelf-life and retest date management, to ensure seamless clinical supply
• Lead and manage reference standard, in-process control, and specification strategies across the pipeline
• Review and approve a broad spectrum of documents (Test Methods, Qualification / Validation Protocols, Specifications, Reports, etc.) at CMOs
• Generate, review and approve documents related to the control of DS and DP for Regulatory submissions (IND/IMPD and NDA/MAA)
• Visit contract manufacturing sites both domestically and internationally to support key production milestones and build excellent business relationships

Qualifications

• MS with 15+ or PhD with 10+ years of relevant experience in the development and application of analytical control strategies for both drug substance and drug product
• Expert in the development of test methods that employ advanced analytical techniques for Quality Control (UPLC, GC, MS, PSD, etc.)
• Proficient at troubleshooting analytical methods at CMOs
• Proven track record and leadership in phase-appropriate analytical control strategies from early development through pivotal studies
• Well versed in Regulatory CMC and ICH guidance
• Highly effective collaborator with “customers” in DS and DP, QA and RA
• Positive work presence; responds to stress and ambiguity with humor

Position Overview

We are seeking a Scientist II/ Senior Scientist I with hands‑on experience in phase‑appropriate analytical method development, optimization, qualification, and transfer to support the release, stability, and characterization of cell and gene therapy products. This role will mainly support Beam’s in vivo lipid nanoparticle (LNP) based programs and will be based in a laboratory environment.

The ideal candidate will have experience in design and development of analytical methods for mRNA, gRNA, protein, protein conjugate, lipid, and LNP, experience working collaboratively with cross-functional research and CMC teams, and have a working knowledge of analytical ICH/USP guidelines.

Primary Responsibilities:

• Lead early through late phase method development, optimization, and transfer for lot release, stability, and characterization of drug substances, critical materials, and drug products.
• Establish technical leadership as subject matter expert in multiple analytical techniques during method development and transfer and provide technical troubleshooting support when needed.
• Work with cross-functional groups including Research & Development, Quality Control, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation.
• Coordinate routine sample testing including requests from Research and Development groups and Process Development teams.
• Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
• Maintaining detailed documentation of experiments in ELN system.
• Adapting to a fast-paced, dynamic research environment.
• Mentor and train junior scientists
• Living Beam Therapeutics core values of being part of a community of fearless innovators, being rigorous and honest in our research, listening with open minds, and committed to each other.

Qualifications:

• Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields). Minimum PhD with 2+ years or BS/MS with 10-15 years (title based on experience) industry experience including biotech, biopharma, CRO, and CDMO.
• Must have hand on experience on analytical method development, optimization, qualification, and testing at GMP or non-GMP environments, supporting clinical phase programs.
• Experience with analysis of RNAs, proteins, protein conjugates, lipids, and lipid nanoparticles (LNPs) is highly desirable and will be key to success in this role.
• Extensive experience with at least one or several of the analytical techniques is required: HPLC (RP, IPRP, SEC, IEX), capillary gel electrophoresis, ELISA. Experience with qPCR, DNA and RNA extraction, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
• Experience with analytical CMC development, method transfer, and QC technical support is highly desirable.
• A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept.
• CMC project management and people management experience will be a plus.
• Familiarity with data analysis software such as Openlab, Chromeleon, and statistical software such as JMP.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented scientist with excellent critical thinking and problem-solving abilities.
• Excellent organizational skills towards multi-tasking in an extremely fast-paced environment with changing priorities.
• Must be able to work onsite daily

About the Role:

Stylus Medicine is seeking an intellectually curious and collaborative Senior Scientist, who will lead the development of upstream microbial fermentation processes as part of our CMC Tech Ops team. This role will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to pilot. Working closely with the Research, Preclinical, and Formulation teams, this is a special opportunity to advance the development of transformative in vivo genetic medicines.

Key Responsibilities & Accountabilities:

• Develop scalable production processes for nucleic acids and recombinant proteins
• Leverage expertise in fermentation and mammalian cell culture to design, optimize, scale-up and characterize production processes
• Independently utilize multivariate design of experiment (DoE) approaches to improve productivity and optimize parameters for product quality
• Drive fermentation platform development and new technology implementation to improve process performance, generation of predictive process models, and enhance process control and robustness
• Design and implement in-process analytics to improve productivity while reducing process and product derived impurities
• Maintain and troubleshoot equipment to ensure consistency and continuity of operations
• Document, analyze and present experimental results internally and externally
• Partner with CDMOs and provide technology transfer support to facilitate scale up
• Interface with cross-functional teams to ensure programs are on track and stakeholders’ needs are met
• Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

Qualifications & Skills:

• PhD in Chemical/Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline with >4 years of experience, or BS/MS with >8 years of experience in biopharmaceutical or biotechnology development, including experience in developing scalable fermentation processes for producing plasmid DNA and/or recombinant products
• In-depth experience and knowledge in fermentation process development, optimization, and process scale-up / scale-down model development
• Familiarity with strain engineering and biocatalysis
• Familiarity with performing operations in a cleanroom environment, applying controls to ensure aseptic processing
• Demonstrated ability to coach and mentor junior researchers
• Independently motivated and good problem-solving ability
• Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must
• Demonstrated ability to work collaboratively across teams to meet project deliverables and timelines
• Strong communication, decision-making and organizational skills
• Proficiency with statistical analysis software (e.g., JMP) is highly desired
• Prior experience partnering with external CDMOs and conducting tech transfers preferred

Pay Range: $155,000 - $170,000

The Opportunity

Amylyx is looking for a highly experienced Senior Director, Chemistry, Manufacturing, and Controls (CMC), to lead the CMC organization to develop Amylyx’s pipeline including Phase III synthetic peptide, Avexitide, and Phase I antisense oligonucleotide, AMX0114. The CMC group works with external CDMOs to develop robust, scalable, compliant processes for clinical and commercial supply. The Senior Director may lead directly or manage the leads of internal matrix CMC Asset teams and represent CMC on Asset program teams. This leader will work cross-functionally to drive technical excellence and ensure CMC readiness and alignment to program goals.

The ideal candidate will combine strong strategic leadership while working closely with teams and actively contributing to hands-on execution when needed. This role reports to the Senior Vice President, Global CMC and External Manufacturing.

Responsibilities

Strategic Leadership

• Partner with Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing teams to execute CMC strategies for drug development from early-phase through commercialization aligned with asset development plans.
• Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams.
• Provide guidance on timelines, budgets, and risk mitigation strategies.
• Evaluate new CDMOs to support tox and clinical material needs. Provide technical leadership for all due diligence and tech transfer projects.
• Travel to global manufacturing sites to support development operations and foster collaboration.

CMC Leadership

• Manage CMC leads and/or lead key matrix CMC Asset teams when needed.
• Author and/or review CMC sections of IND, NDA, and global regulatory submissions (Module 3).
• Ensure compliance with cGMP, ICH guidelines, and FDA CMC requirements.

Process Development & Scale-Up

• Lead phase-appropriate process development, optimization, and validation activities.
• Recommend scientifically rigorous, phase-appropriate, risk management-based solutions to complex technical challenges.
• Develop impurity control strategies and ensure processes meet global regulatory standards.
• Serve as the technical subject matter expert (SME) and process owner when needed.
• Drive successful technology transfers and monitor clinical manufacturing operations, including batch record review and data trending.

Project Management

• Lead and mentor a team of technical professionals, fostering a culture of collaboration, accountability, and continuous improvement.
• Provide career development guidance, performance feedback, and succession planning for team members.
• Allocate resources effectively across projects and ensure alignment with organizational priorities.
• Promote technical excellence through coaching, training, and knowledge-sharing initiatives.
• Drive engagement and retention by creating an inclusive and supportive work environment.

Required Qualifications

• Advanced degree in chemistry, chemical engineering, or related field.
• A solid understanding of small molecule, RNA, and peptide/amino acid chemistries.
• At least 15 years of experience in technical process development from early through late phase. Prior process validation experience preferred.
• Expertise in developing phase-appropriate oligonucleotide and/or synthetic peptide manufacturing processes.
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA, EMA, JP CMC Guidance Documents.
• A strong track record of successful global CMC submissions and approvals.
• Must be able to function independently, influence appropriate stakeholders, and build relationships internally and externally.
• Experience partnering with contract manufacturing organizations.
• Excelling leadership, communication, and collaboration skills.
• Ability to travel internationally up to 10%.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
• When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Philo: a streaming service for TV and movie lovers

At Philo, we’re a group of technology and product people who set out to build the future of television, marrying the best in modern technology with the most compelling medium ever invented — in short, we’re building the TV experience that we’ve always wanted for ourselves. In practice this means leveraging cloud delivery, modern tech stacks, machine learning, and hand-crafted native app experiences on all of our platforms. We aim to deliver a rock solid experience on the streaming basics, while cooking up next generation multi-screen and multi-user playback experiences.

Data at Philo

Data underpins everything we do at Philo: making informed business decisions; analyzing and improving the quality of our streaming experience; running product experiments to optimize our signup flows and improve user journeys; and making it effortless for our users to find the perfect thing to watch. Philo serves over a billion streams to its users every year, generating a wealth of data that we leverage at all levels of the organization. Philo’s data platform operates at very large scale, processing trillions of events annually in a petabyte-scale data lake and supporting thousands of data workflows and analytical queries that power decision-making across the company.

Philo’s Data Engineering team encompasses both data engineering and analytics engineering, and we’re looking for people who are comfortable working on complex data infrastructure and modeling challenges that support critical business functions across our streaming services. You’ll be working closely with other data scientists, analysts, and engineers to build and deploy solutions directly for our service – this work spans both foundational data platform work like data warehouse architecture, metric governance, and semantic consistency across our entire data stack. In addition, you’ll work with departments across the organization to understand their data needs and deliver high-performance, reliable data systems to help the entire team thrive.

We are passionate about building robust, scalable data infrastructure and providing a high-quality data platform for the entire company, using both cutting-edge technologies and proven engineering practices in close collaboration with every department. To complete our work, we build on modern tools including AWS-native services, dbt, Segment, Snowflake, AWS SageMaker, Spark, Avo, BigEye and more.

Some of the recent projects that data and analytics engineers at Philo have worked on include building new models for key financial data, dbt model design, data warehouse cluster upgrades and maintenance, per-query infra cost optimization, implementation of Apache Iceberg data storage, benchmarking & improving data warehouse performance, and evaluating alternative data warehouse technologies.

The Role

We're seeking a senior technical and foundational leader to own and drive the vision, strategy, and execution of our Data Engineering team, encompassing both the data engineering and analytics engineering  functions at Philo. This is a strategic and high-impact role: you'll set the long-term direction for our entire data platform, lead and grow a team of data and analytics engineers, and roll up your sleeves to architect and build alongside them. The ideal candidate has owned both disciplines before — data infrastructure and analytics engineering — and brings strong opinions on how to structure a high-velocity, high-trust data organization. 

Responsibilities:

• Own the vision and technical strategy for data engineering and analytics engineering at Philo, setting the direction for how data is ingested, modeled, and delivered across the organization
• Own the team’s roadmap, balancing strategic long-term investments with near-term stakeholder needs
• Lead and grow the Data Engineering team, including hiring, career development, performance management, and supporting the team in generally thriving
• Lead the design and implementation of Philo's data platform architecture, including  setting technical standards and best practices for data engineering and analytics engineering work
• Collaborate with cross-functional teams to understand data platform needs and translate business requirements into technical solutions
• Build and maintain stakeholder trust in data and reporting — ensuring that business teams have reliable, well-documented, and well-understood data products
• Design scalable data pipelines and infrastructure; drive technical decisions with a focus on long-term sustainability
• Implement data governance, security, and quality control processes as needed
• Ultimately, deliver on the alchemy of transforming raw, messy application data into trusted business insight through scalable dimensional modeling and a metric layer that faithfully reflects product and customer behavior.

Key Qualifications:

• 10+ years of professional experience spanning data engineering and analytics engineering, ideally with a few years working on high-volume data platforms
• 4+ years of experience managing and leading data teams, with demonstrated experience owning both data engineering and analytics engineering functions at a prior organization
• Deep expertise in modern data stack technologies, particularly AWS data services, Snowflake, dbt, Airflow, Airbyte, Python, and SQL
• Deep expertise in analytics engineering, including dbt model design, dimensional modeling, and delivering trusted, business-facing data products
• Strong people management skills with experience providing coaching, performance feedback, and career development guidance to direct reports.
• Track record of improving stakeholder trust in reporting and data quality across an organization
• Strong track record of designing and implementing data platforms
• Excellent communication skills with technical and non-technical stakeholders, simplifying complex data concepts for various business audiences

Ideal Qualifications:

• Experience in media/streaming industry with understanding of video delivery analytics and metrics
• Demonstrated experience driving organizational alignment around data definitions, metrics, and a single source of truth
• Experience with data governance and compliance requirements
• Background in implementing data quality frameworks

More about Philo

At Philo, we’re a company that puts people first—both our subscribers and our team. We empower our colleagues to do their best work while supporting one another in pursuing shared goals. We value pragmatism, pride in our work, and passion, with transparency and openness as fundamental parts of our culture.

We’re committed to diversity, equity, inclusion, and accessibility as we grow the Philo team and shape the future of TV. We believe that a diverse range of voices and perspectives enables us to innovate faster and create the best experiences for our subscribers. Philo is proud to be an Equal Opportunity Employer. We’re committed to supporting every candidate and employee. If you need an accommodation at any stage of the process, please email recruiting@philo.com and we’ll work with you to meet your needs.

Philo offers 70+ top-rated networks streaming live and on-demand, including AMC, BET, CMT, Comedy Central, Discovery Channel, Food Network, Hallmark Channel, HGTV, HISTORY, Investigation Discovery, Lifetime, MTV, Nickelodeon, OWN, VH1, We TV, and more. It also includes all the groundbreaking originals and blockbuster movies available with AMC+ and access to HBO Max Basic With Ads and discovery+. Our service also includes 100+ free channels and premium add-ons like STARZ and MGM+.

Our extensive library boasts over 85,000 titles, and our unlimited DVR allows users to save their favorite shows and movies for up to a year, skipping ads for a seamless viewing experience. Stream on up to three devices simultaneously, whether on your phone, tablet, laptop, or TV using Roku, Apple TV, Fire TV, Samsung TV, Android TV, Vizio TV, or Chromecast.

Philo is headquartered in San Francisco, with offices in New York City and Cambridge, MA. Our leadership team includes alums from HBO, Tubi, and Meraki, and is backed by NEA and industry partners like Warner Brothers Discovery, Viacom, AMC, and A&E.

Join us at Philo and be part of a team that's shaping the future of TV!

Status: Full-time
Location: San Francisco, CA, Brooklyn, NY, Cambridge, MA, or remote within the U.S.
Compensation: Includes annual salary, company stock options, and health benefits. Salary is determined by experience and location:

• San Francisco, New York City: $240K - $275K
• Boston, DC Metro, Los Angeles, Seattle: $225K - $260K
• Denver, Atlanta, Austin, Las Vegas, Sacramento, Chicago: $215K - $250K
• Texas, Florida: $200K - $235K

We value a diverse and inclusive workplace and we welcome people of different backgrounds, experiences, skills, and perspectives. Philo is an equal opportunity employer. We believe that everyone does their best work when they are supported by each other and the company, and we offer a generous set of benefits to make sure the Philo team is happy and healthy. Here is a sampling of the benefits we offer our team:

• Full health, dental and vision coverage for you and your family
• 401(k) plan with employer contributions (we match 100% of deferrals up to 3% of pay and 50% of the next 2% of pay)
• Flexible working hours
• Up to 20 weeks of fully paid parental leave
• Unlimited paid time off for vacation and sick leave
• $2,000 annual vacation bonus (we pay you to take a two week vacation)
• $5,250 annually for professional development and educational assistance
• $1,250 annual home office + TV stipend during first year of employment ($250 annually thereafter)
• $500/month ($6,000/year) bonus for employees who commit to working at least 3 days per week in our offices, plus generous commuter benefits ($315/month towards transit, rideshare, bike rental, or parking at our HQ office in San Francisco)
• Free Gympass subscription — an all-in-one corporate benefit that gives employees the largest selection of gyms, studios, classes, training and wellness apps
• Dog-friendly office
• And much more!

For California Residents: Philo’s CCPA Notice at Collection – Employees, Applicants, Owners, Directors, Officers and Contractors

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

About the Role

• Serve as the lead electrical engineer responsible for the design, development, and integration of electronics for Nanopath’s diagnostic platform
• Own system-level electrical architecture, including PCB design, power management, signal integrity, and integration with embedded software and mechanical subsystems
• Design and develop circuits supporting motion control, fluid actuation, thermal management, and optical detection systems
• Lead bring-up, debugging, and validation of prototypes and production hardware
• Collaborate with cross-functional teams (software, mechanical, systems, assay) to define requirements and ensure seamless system integration
• Develop and maintain documentation in compliance with ISO 13485

Technical Qualifications

• Strong experience in analog and digital circuit design, including mixed-signal systems
• Strong experience with embedded systems and microcontroller-based designs
• Proficiency in PCB design tools and schematic capture/layout best practices
• Background in designing systems with precise thermal control, motor control, fluidic actuation, or optical detection
• Experience developing hardware for medical devices regulated to ISO 13485 and IEC 61010
• Experience supporting hardware verification, validation, and troubleshooting through all development phases
• Exposure to manufacturing processes, including PCB fabrication, assembly, and test

General Qualifications

• B.S. or M.S. electrical engineering or related technical discipline with at least 4 years of industry experience
• Ability to work on-site full-time in Cambridge, MA
• Excellent communication and presentation skills, highly organized with demonstrated curiosity, scientific rigor and creative problem-solving
• Proactive self-starter with eagerness to adapt to a fast-paced, dynamic startup environment
• Passion for technology translation and willingness to shape Nanopath’s future

The Opportunity 

We are seeking a highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you will establish and lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions. 

You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions. 

This is a highly visible leadership role with responsibility for shaping analytical strategies that enable the successful advancement of our clinical pipeline. 

Your Role 

• You will be responsible for setting and executing the analytical development and quality control strategy across our development programs, ensuring phase-appropriate analytical methods and control strategies are in place to support drug substance (DS) and drug product (DP) development. 

• You will lead analytical method development, validation, and lifecycle management activities required for the full characterization of small molecule NCEs. 

• You will provide scientific and strategic oversight of external laboratories, CMOs, and CROs conducting analytical development, method validation, release testing, and stability testing in support of Relay clinical candidates. 

• You will review and approve analytical development strategies, method transfer and validation protocols, datasets, and final reports. 

• You will oversee QC testing performed at external analytical laboratories and DS/DP manufacturing sites to ensure compliance with cGMP standards. 

• You will provide quality oversight and approval of cGMP QC documentation, including change controls, deviations, CAPAs, analytical procedures, and validation protocols. 

• You will review analytical data packages and raw data from third-party laboratories to support batch disposition and release. 

• You will oversee the Reference Standard program, including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories. 

• You will lead activities related to critical quality attributes (CQAs), specifications, stability strategies, data trending, shelf life determinations, and expiry dating for drug substance and drug product. 

• You will define and implement phase-appropriate analytical and stability strategies across all clinical development programs. 

• You will author and review QC and analytical sections of regulatory filings, including INDs and NDAs, and provide technical leadership for responses to Health Authority questions. 

• You will represent the analytical function in cross-functional program teams and contribute to overall CMC strategy and regulatory planning. 

• You will build strong partnerships across Regulatory Affairs, CMC, Quality Assurance, and external partners to ensure alignment on development and regulatory strategies. 

• As the analytical function grows, you may mentor and lead internal scientists or matrix teams, while establishing scalable processes and best practices. 

Your Background 

• You have earned an MS or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or a related discipline, with 10+ years of industry experience, including significant experience leading analytical development activities in a pharmaceutical or biotechnology environment. 

• You have deep expertise in analytical development, method validation, technology transfer, troubleshooting, and quality control for small molecule drug development. 

• You have experience developing analytical strategies across multiple phases of development, including IND-enabling and late-stage programs. 

• Experience supporting regulatory filings (IND, NDA, or equivalent) and interacting with global regulatory agencies such as the FDA, EMA, or PMDA is strongly preferred. 

• You possess strong technical expertise in analytical methods for small molecule drug substances and oral solid dosage forms. 

• You are an effective communicator who can collaborate successfully with cross-functional internal teams, contract laboratories, and manufacturing partners. 
• You are comfortable managing multiple programs and priorities in a dynamic development environment.

Estimated Salary Range: [$160,000 - $228,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1

The Role:

Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations.

This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs.

Responsibilities:

• Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
• Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
• Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
• Partner with or oversee CROs or Programming vendors to perform the tasks described above.
• Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
• Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
• Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).

Competencies Include:

•  Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
• Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
• Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
• Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

 Qualifications:

• Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field.
• 8+ years of (SAS) statistical programming experience in a clinical trial setting (industry/CRO).
• Advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures.
• Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards.
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.
• Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics and data handling in clinical development setting, and advanced knowledge of submission requirements and standards.
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
• Advanced understanding of statistical concepts in support of clinical data analysis.
• Advanced knowledge of programming standards and processes.
• Oncology experience is required.
• Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers.

Position Overview:

Beam is seeking a scientist with expertise in formulation and ligand conjugation. The candidate will work on formulation, ligand conjugation, and scale-up of lipid nanoparticles (LNPs) targeting different organs and cell types. They will work as part of a team to develop drug products with the goal of bringing in vivo base editing to patients.

We are looking for an ambitious candidate who wants to grow within the LNP Sciences group. This candidate will help shape the LNP platform and grow with the aspirations of the organization as we advance into later stages of development.  

Primary Responsibilities:

• Responsible for formulation design, development, characterization, and technology transfer to enable development of Beam sterile drug products.
• Accountable as an individual contributor to support formulation development as well as providing necessary guidance and support of drug product control strategy for drug candidates across all stages of development.
• Independently design, execute, analyze, and document experiments to optimize LNP potency, tolerability, biodistribution, and ligand conjugation.
• Design and execute experiments to enable a robust and reproducible process for manufacture of ligand conjugated LNPs at-scale. Interface closely with Analytical Development and Biotherapeutics teams to characterize different unit operations for the manufacturing of DP to understand process robustness.
• Provide support with tech transfer activities for manufacturing of drug products.
• Generate high quality documentation as per Beam SOPs and in support of regulatory filings.
• Communicate scientifically rigorous findings via verbal and written communications, and presentations both internally and externally.

Qualifications:

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with drug product and CMC development experience (PhD 4+ years or MS 12+ years).
• Deep understanding of sterile product development. Prior industry research experience, especially in nucleic acids and drug delivery, is required. Experience with development of antibody-drug conjugates and/or biologics is preferred.
• Knowledge of statistical techniques and concepts (regression, properties of distributions, statistical tests, and proper usage, etc.).
• Ability to adapt to increasing scope and complexity of work brought on by growth/change and help others manage through change.
• A successful candidate will have excellent computational, written, and verbal communication skills, strong organizational abilities, and an ability to work with a diverse group of scientists and engineers.
• Ability to work in a hybrid environment with sufficient on-site presence.

Principal Software Developer, Cognito Therapeutics, Inc.

Location: Cambridge, MA, USA, Full-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

About the Job

We are seeking a talented and motivated Principal Software Developer to join our dynamic and innovative team. As a Principal Software Developer, you will take the lead in designing, developing, and maintaining high-quality software solutions that meet our product and business needs.  You will collaborate closely with cross-functional teams, including product managers, designers, and quality assurance professionals, to deliver exceptional software products that drive our business forward.  You’ll take ownership of software projects in critical areas. As the company expands you will lead and guide peers and junior technical staff in your area(s) of expertise. 

Roles & Responsibilities:

• Develop high-quality software solutions: Design, code, test, and debug software applications using programming languages and frameworks such as Java, C, C++, Python, or JavaScript, ensuring adherence to coding standards and best practices.
• Collaborate with cross-functional teams: Work closely with product managers, designers, and other stakeholders to understand requirements, provide technical insights, and contribute to the overall product vision.
• Lead through the full software development life cycle: Contribute to all phases of the software development process, including requirements gathering, design, implementation, testing, deployment, and maintenance.
• Perform code reviews and ensure software quality: Review code written by team members, provide constructive feedback, and conduct thorough testing to identify and fix bugs, ensuring software quality and reliability.
• Stay up-to-date with industry trends: Continuously learn and stay current with the latest tools, technologies, and programming languages relevant to software development, and propose innovative solutions to enhance our software products.
• Troubleshoot and resolve technical issues: Investigate and address software defects, performance bottlenecks, and other technical issues, collaborating with the team to find effective solutions.
• Collaborate in an Agile environment: Run Agile ceremonies, such as sprint planning, daily stand-ups, and retrospectives, fostering a collaborative and iterative approach to software development.
• Lead Projects: Manage small technical teams, and interface with peers and superiors to reach outcomes important to the company.
• Mentor Junior Staff: Provide technical and career guidance to more junior software staff, fostering an environment of collaboration, technical excellence and growth.
• Document and Communicate: Create and maintain technical documentation, including design specifications, user manuals, and API documentation, and effectively communicate complex technical concepts to both technical and non-technical stakeholders. 

Who You Are 

Join our team as a Principal Software Developer and contribute to the development of innovative software solutions that drive our organization's success. Together, we can make a meaningful impact and create exceptional software products that exceed our customers' expectations.

Minimal Qualifications

• Bachelor's degree in Computer Science, Software Engineering, or a related field. Equivalent work experience may be considered.
• 8+ years of Software Development experience
• Demonstrated experience leading complex technical projects or systems, with expertise in one or more programming languages and frameworks.
• Strong problem-solving skills and ability to analyze complex problems, propose creative solutions, and implement them effectively.
• Solid understanding of software development principles, practices, and methodologies, including Agile/Scrum.
• Familiarity with version control systems (e.g., Git), software testing, and debugging tools.
• Excellent teamwork and communication skills, with the ability to collaborate effectively with cross-functional teams and articulate technical concepts to non-technical stakeholders.
• Experience leading small technical teams, where you remain a highly engaged individual contributor.
• Strong attention to detail and a commitment to delivering high-quality software solutions. Strong technical opinions driven by experience and expertise.
• Continuous learning mindset and a passion for staying up-to-date with emerging technologies and industry trends.
• Software Development Life Cycle experience is a plus
• Medical Device Experience is a plus
• Programming with mobile applications is a plus
• Embedded device experience is a plus
• FDA Cybersecurity compliance experience is a plus
• Cloud application development is a plus
• Leading a team of software developers.

The Opportunity

The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterprise‑level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP‑relevant computerized systems, with a strong emphasis on the Veeva Quality Suite. This role ensures that digital quality solutions and supporting systems meet global regulatory requirements (FDA, EMA, ICH, GAMP 5), maintain data integrity, and enable a sustainable, inspection‑ready state across the organization.

This person will partner closely with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, lead new system implementations and major enhancements, and drive harmonized, risk‑based validation practices. This role also oversees quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely closure, trend analysis, and effective governance through leadership of key forums including Quality Management Review and cross‑functional compliance meetings.

Responsibilities

Strategic Leadership & Governance

• Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System (QMS) objectives.
• Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
• Oversee enterprise-wide governance programs, ensuring standardized, risk‑based approaches to system implementation and maintenance.
• Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity.

Computer System Validation & Lifecycle Oversight

• Lead planning, execution, review, and approval of validation deliverables across GxP systems.
• Oversee system lifecycle activities including impact assessments, change management, periodic reviews, audit trails, user access reviews, and system retirement.
• Promote and reinforce CSA‑aligned, risk‑based validation practices to streamline compliance and maximize efficiency.
• Ensure documentation quality and consistent application of SDLC principles across projects.

Veeva Systems Expertise & Optimization

• Serve as the Quality SME for the Veeva Quality Suite, providing expert guidance on configuration, workflow optimization, and release readiness.
• Lead implementation, enhancement, and optimization of Veeva Vault modules and cross‑functional integrations.
• Drive automation and digitization initiatives that improve usability, compliance, and system performance.
• Partner with IT and Veeva administrators to maintain robust, compliant change control processes.

Quality & Regulatory Compliance

• Ensure all computerized systems maintain compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
• Author, revise, and own Quality System policies and procedures related to electronic systems and validation.
• Represent Quality during internal audits, external regulatory inspections, and vendor assessments.
• Lead timely remediation, effectiveness checks, and continuous improvement initiatives.
• Provide oversight and trending for Quality Events related to system performance or compliance.

Required Qualifications

• Bachelor’s degree in a relevant scientific or technical discipline.
• 8+ years of experience in the life sciences industry with strong GxP system experience.
• Extensive leadership experience in cross functional implementation and validation of GxP computerized systems.
• Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training, etc.).
• Strong knowledge of global regulatory expectations and data integrity frameworks.
• Demonstrated ability to lead enterprise programs, influence stakeholders, and drive compliant decision making.

Preferred Qualifications

• Expertise with SaaS/cloud architectures and database compliance expectations.
• Understanding of clinical data collection technologies and supporting data processes.
• Familiarity with SDLC, Agile methodologies, CSV vs. CSA principles and automated testing platforms.
• Experience developing and interpreting Quality metrics such as KPIs and KQIs.
• Excellent communication skills with the ability to collaborate, negotiate, and influence at all organizational levels.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
• You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location.

Summary

DivcoWest is seeking a knowledgeable and responsible building operations & engineering professional to join our Property Management Team. As the Operations Manager, you will plan, implement, coordinate, and manage all mechanical operations, maintenance, communications, energy management, and engineering staff programs for the assigned properties owned/managed by DivcoWest. You will be responsible for oversight of third-party engineering as well as physical operational oversight at the properties. You will be working in daily collaboration with the on-site property management teams and asset management team. You will be working with and reporting directly to the local Associate Director (Property Management - Operations).

This is a full-time role requiring five (5) days on-site at our Cambridge, Massachusetts properties.  Attendance at or remote availability in the evenings or weekends may be required for projects and/or emergency situations. 

The ideal candidate must take the initiative to lead projects and ongoing efforts and give direction but must also be comfortable collaborating with multiple stakeholders working on the properties. Problem-solving and communication abilities are equally important.

Responsibilities

• Accountable for all aspects of engineering and technology activities at the assigned properties to ensure business objectives are met.
• Serves as the primary technical authority and technical interface for engineering team, property management and asset management at the properties.
• Recommend and make strategic supervisory decisions in conjunction with the national Senior Director and the local Associate Director.
• Assists in creating and ensuring compliance with departmental policies, standards, and procedures.
• Coordinate activities of third-party engineering staff and collaborate on appropriate engineering staffing levels.
• Evaluate repair/maintenance/upgrade contractor qualifications and recommendations and ensure proposals have sound solutions, schedules, drive affordability.
• Provides status updates to the property team of contractor activities.
• Ensure contracts under their purview are administered.
• Supervise and review all technical operations of MEP/LS systems and equipment including but not limited to air handling & distribution, water pumping & distribution, hot water & steam boilers, district steam, domestic hot water, chillers and cooling towers, water quality & treatment, building management/automation systems, electrical power and control systems, teldata & networking, fire alarm & fire protection systems, and other commercial building systems of various configurations and vintages.
• Manage all facets of inspections and surveys, including energy audits and analysis, HVAC, electrical and plumbing systems, environmental compliance, and third-party.
• Develop and provide ongoing improvement of preventive maintenance and engineering procedures & programs, hazardous materials communications plan, and indoor air quality programs.
• Responsible for maintaining regulatory requirements and rectifying building, code or fire violations.
• Oversee implementation of programs to ensure compliance with life safety programs and procedures, evacuation plans, domestic water quality control and water treatment programs, and environmental and workplace safety Leads an emergency response program when necessary and appropriate.
• Recommend and estimate property repairs and improvements for inclusion in the annual operating and capital budgets.
• Evaluate and recommend building automation, energy management and automatic temperature control.
• Conduct assessment of physical property, mechanical, electrical, and other building systems as needed or requested.
• Coordinate & fully communicate with tenant maintenance teams to ensure transparency with maintenance activities of all building equipment.
• Review, assess and provide recommendations on property.
• Oversee execution of deferred maintenance and MEP enhancement capital.
• Oversee tenant-related construction and renovation activities to ensure building integrity, including pre-construction review of drawings with the project management and property management teams.
• Ensure a high level of customer service is being delivered to the tenants and interactions are handled professionally, ethically and with poise, diplomacy, and courtesy.
• Utilize and implement technology to engage the operations of the property.
• Maintain up-to-date records.
• Assist with due diligence and building evaluations for possible acquisitions or development.
• Perform other duties as assigned.

Qualifications

• 5+ years of facilities engineering and operations experience required.
• Strong technical knowledge of building systems, plumbing, fire life safety, electrical, mechanical, HVAC, etc.
• Knowledge and understanding of all applicable practices and techniques, laws, project controls and environmental regulations to include safety regulations.
• Experience with life science, medical office, laboratory buildings, data centers and/or critical infrastructure preferred.
• NFPA FPPM Certification Preferred.
• Proficiency in problem-solving, organized, task and detail-oriented, and able to work in a fast-paced environment.
• Business acumen includes financial planning and
• Excellent interpersonal, communication, negotiation, and presentation
• Ability to develop and maintain effective working relationships with vendors, contractors, employees and coworkers.
• Proven experience with sustainability and energy conservation programs in commercial or institutional buildings. LEED accreditation is desirable.
• Computer literate including proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint). Familiarity with CADD, BMS systems, work order and maintenance management
• Ability to read construction drawings and schematics.
• Communicate effectively both verbally and in writing and able to effectively collaborate with engineering, contractors, property management and asset management.
• Strong written, verbal and presentation skills to comprehend, analyze, and interpret complex and technical matters.
• Effectively communicate to various stakeholders, including but not limited to engineering teams, property management teams, engineering vendors and senior leadership. 
• Must be flexible to travel.

The person in this position must be able to:

• Remain in a stationary position for 75% of the time working on a computer and attending virtual meetings.
• Occasionally move about the office to access file cabinets, office technology, and attend meetings etc.
• Constantly operate a computer and other office productivity machinery, such as a printer and presentation displays as well as operate marketing tools to capture photos and video.
• Move about outside the office to tour properties, including mechanical/electrical spaces and roofs.
• Occasionally use and manipulate building equipment and tools to alter building operating conditions.
• Set up for marketing initiatives such as events, photo shoots, property tours, etc. and occasionally lift objects up to 20 lbs.

Compensation

• $95,000-$115,000
• Annual bonus opportunity
• Full benefits 
• 401k match
• Flexible vacation policy
• Weekly lunch stipend

The Lead Building Engineer leads and oversees the day-to-day operations and maintenance of building systems, ensuring efficient and safe building performance while supervising engineering staff and contractors.

Essential Duties and Responsibilities:

• Monitor the operating condition of all HVAC, plumbing, and electrical equipment.
• Coordinate preventive maintenance and emergency repairs for the building.
• Oversee service contractors while ensuring compliance with building standards.
• Supervise and mentor junior Engineers and Technicians; assist in setting staff performance goals and evaluating progress.
• Collaborate with tenants, contractors, and property managers to ensure reliable building operations and resolve tenant issues.
• As assigned, work with vendors to identify scopes of work and oversee compliance with contract terms and quality control.
• Conduct regular building inspections and proactively address deficiencies
• Manage preventive maintenance schedules and ensure they are executed effectively.
• Record equipment readings and ensure assigned building systems are operating according to standards.
• Follow company safety protocols and wear appropriate PPE; ensure compliance with OSHA, NEC, NFC, NFPA regulations; report safety hazards; participate in safety inspections; ensure all staff follow safety protocols and comply with building codes and regulations; oversee safety training and maintain compliance logs.
• Communicate verbally and in writing with teammates, leadership team, vendors, tenants, and client employees in a professional manner, keeping the appropriate customer(s) informed/updated as needed.
• Perform other duties as assigned.

Qualifications:

• HS Diploma or GED required
• Five to seven years of industry-related experience or commensurate certification/trade experience
• At least one year of formal or informal supervisory, training, and/or mentoring experience
• CFC Certification preferred or willingness to obtain as requested; possess engineering and trade licenses required according to local, state, or national requirements
• In-depth knowledge of Microsoft Office products, energy management software systems, CMMS, and other building operational platforms
• Familiar with fire/life safety equipment/procedures
• Proven track record of delivering excellent internal and external customer service; ability to successfully interact/communicate with tenants/vendors/contractors as well as teammates and leadership team
• Familiarity with blueprints and code requirements
• Ability to work after hours, weekends, holidays, and during emergency situations as necessary to meet the needs of the client
• Possess competent knowledge of use and care of tools
• Ability to read and write English in order to understand manuals and procedures, and to write reports.
• Ability to demonstrate in-depth knowledge of building automation systems (BAS), HVAC, and electrical controls with skills in troubleshooting complex mechanical and electrical systems

Physical Requirements:

Ability to stand, walk, climb ladders, and lift up to 50 pounds; perform physically demanding tasks such as stooping, crouching, and kneeling.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

This position is 100% in-office. The role requires working in office during standard business hours. Remote work or telecommuting is not an option for this position.

#IND123

The Lead Building Engineer leads and oversees the day-to-day operations and maintenance of building systems, ensuring efficient and safe building performance while supervising engineering staff and contractors.

Essential Duties and Responsibilities:

• Monitor the operating condition of all HVAC, plumbing, and electrical equipment.
• Coordinate preventive maintenance and emergency repairs for the building.
• Oversee service contractors while ensuring compliance with building standards.
• Supervise and mentor junior Engineers and Technicians; assist in setting staff performance goals and evaluating progress.
• Collaborate with tenants, contractors, and property managers to ensure reliable building operations and resolve tenant issues.
• As assigned, work with vendors to identify scopes of work and oversee compliance with contract terms and quality control.
• Conduct regular building inspections and proactively address deficiencies
• Manage preventive maintenance schedules and ensure they are executed effectively.
• Record equipment readings and ensure assigned building systems are operating according to standards.
• Follow company safety protocols and wear appropriate PPE; ensure compliance with OSHA, NEC, NFC, NFPA regulations; report safety hazards; participate in safety inspections; ensure all staff follow safety protocols and comply with building codes and regulations; oversee safety training and maintain compliance logs.
• Communicate verbally and in writing with teammates, leadership team, vendors, tenants, and client employees in a professional manner, keeping the appropriate customer(s) informed/updated as needed.
• Perform other duties as assigned.

Qualifications:

• HS Diploma or GED required
• Five to seven years of industry-related experience or commensurate certification/trade experience
• At least one year of formal or informal supervisory, training, and/or mentoring experience
• CFC Certification preferred or willingness to obtain as requested; possess engineering and trade licenses required according to local, state, or national requirements
• In-depth knowledge of Microsoft Office products, energy management software systems, CMMS, and other building operational platforms
• Familiar with fire/life safety equipment/procedures
• Proven track record of delivering excellent internal and external customer service; ability to successfully interact/communicate with tenants/vendors/contractors as well as teammates and leadership team
• Familiarity with blueprints and code requirements
• Ability to work after hours, weekends, holidays, and during emergency situations as necessary to meet the needs of the client
• Possess competent knowledge of use and care of tools
• Ability to read and write English in order to understand manuals and procedures, and to write reports.
• Ability to demonstrate in-depth knowledge of building automation systems (BAS), HVAC, and electrical controls with skills in troubleshooting complex mechanical and electrical systems

Physical Requirements:

Ability to stand, walk, climb ladders, and lift up to 50 pounds; perform physically demanding tasks such as stooping, crouching, and kneeling.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

This position is 100% in-office. The role requires working in office during standard business hours. Remote work or telecommuting is not an option for this position.

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