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.

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock 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 AR^ON 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 Senior Manager, Supply Chain will lead the end-to-end operational management of investigational product (IP) and clinical trial materials across global Phase I–III studies. This role is responsible for ensuring timely, compliant, and efficient delivery of clinical supplies, while partnering cross-functionally with Clinical Operations, Quality, Regulatory, CMC, and external vendors to support study execution.

• Develop and maintain study-level supply plans and forecasts aligned with enrollment, protocol design, and site activation timelines
• Coordinate packaging, labeling, release, and global distribution of investigational products and ancillary materials
• Oversee inventory across depots and study sites, proactively mitigating risks to avoid shortages or excess
• Serve as business owner of the IRT system, including setup, configuration, validation, and ongoing management
• Partner cross-functionally to align supply strategy with clinical and regulatory requirements and ensure seamless execution
• Author and maintain supply-related documentation, including SOPs, Pharmacy Manuals, and study-specific materials
• Ensure compliance with GxP, GDP, and ICH-GCP standards, supporting audits and inspection readiness
• Manage global logistics, vendor oversight, and third-party partners to ensure uninterrupted supply across regions

What you’ll need to be successful:

• Bachelor’s degree in Supply Chain, Life Sciences, or related field (Master’s preferred)
• Minimum 5 years of global clinical supply chain experience within biotech, pharma, or medical device
• Hands-on experience with IRT/IXRS systems (e.g., 4G Clinical, Almac, Endpoint)
• Experience supporting global Phase I–III clinical trials (commercial launch experience preferred)
• Proficiency with Microsoft Office and inventory/ERP systems
• Strong understanding of GxP, GDP, and ICH-GCP regulations
• Proven ability to manage complex global supply operations and mitigate risk
• Strong analytical, organizational, and problem-solving skills
• Effective cross-functional collaboration and communication across internal teams and external partners
• Experience drafting SOPs, Pharmacy Manuals, and clinical supply documentation preferred
• Familiarity with cold chain and temperature-controlled distribution preferred
• APICS/CSCP or PMP certification a plus
• Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus
• Able to work on-site and attend in-person meetings
• Ability to travel up to 15%

Core Values

Parabilis 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 target for this position is $153,000-$180,000 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 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

Your Impact at LILA

We’re seeking a Head of Supply Chain & Strategic Sourcing to design and scale the function that keeps our scientific platform moving. You’ll own sourcing, procurement, vendor management, inventory, and payments with responsibility for hundreds of millions in annual spend across scientific equipment, lab operations, consumables, and technology infrastructure.

This role sits at the intersection of science, engineering, and finance. You’ll work closely with R&D, engineering, and AI research teams to ensure material availability, supplier performance, cost optimization, and operational resilience. If you’ve built procurement functions in environments where the stakes are high and the pace is fast whether in biotech, AI infrastructure, advanced materials, or hardware this is the role for you.

What You'll Be Building

• Design and scale the end-to-end Procure-to-Pay (P2P) process: sourcing strategy, purchasing channels, vendor governance, and payment operations.
• Lead strategic sourcing: supplier selection, contract negotiations, and ongoing vendor management.
• Build scalable supply chain infrastructure to support complex labs, capital equipment programs, specialized materials, and evolving R&D needs.
• Implement and optimize ERP/P2P systems, automation, and operations (procurement tools, AP workflows, controls).
• Create KPIs and dashboards to drive cost savings, supplier performance, and working capital optimization.
• Establish governance, policies, internal controls, and scalable systems for compliance and audit readiness.
• Centralize procurement operations to align purchasing, payments, leasing, and working capital management.

What You’ll Need to Succeed

• 10+ years of progressive leadership in procurement, supply chain, or P2P operations.
• Experience building or transforming supply chain/P2P in a high-growth setting.
• Experience in biotech, life sciences, AI, advanced materials, or hardware-enabled environments.
• Deep knowledge of ERP and procurement systems (examples: NetSuite, Coupa, Ariba, Ramp; familiarity with Prendo if applicable).
• Proven success negotiating complex supplier agreements and driving cost optimization.
• Experience leading cross-functional teams through rapid growth in spend and headcount.
• Experience implementing modern procurement or ERP systems to replace legacy infrastructure.
• Experience overseeing leasing and equipment financing aligned with capital strategy.

Bonus Points For

• Familiarity with public-company readiness, SOX compliance, and audit environments.
• Experience developing equipment leasing and financing strategies to optimize capital deployment and cash flow.
• Relevant certifications (e.g., MBA, CPIM, CPSM) or equivalent experience.

Your Impact at LILA

The Staff/Principal DevOps Engineer will drive the design, implementation, and optimization of our infrastructure and delivery platforms. This role bridges platform engineering, site reliability, and DevOps practices, building scalable, automated systems that enable fast, reliable software delivery across cloud and Kubernetes environments. You will collaborate with software engineers, lab scientists, and ML engineers to build infrastructure that powers automated scientific analysis, experiment orchestration, and more.

What You'll Be Building

• Build Kubernetes-based infrastructure supporting scientific services, ML pipelines, and platform workloads; including production hardening, RBAC, network policies, and Pod Security Standards
• CI/CD pipelines with GitHub Actions/GitLab CI implementing best practices: build attestations, SBOM generation, dependency scanning, and container image hardening
• Infrastructure-as-code with Terraform and Helm; policy-as-code guardrails (OPA/Kyverno/Checkov) with drift detection
• AWS cloud infrastructure: EKS clusters, IAM least privilege, VPC/PrivateLink networking, KMS/Secrets Manager, ECR, S3, and centralized logging/monitoring
• Platform tooling to streamline deployment, observability, and developer workflows, enabling self-service with secure defaults
• Reliability engineering: SLOs/SLIs, incident response, capacity planning, and performance optimization throughout the stack
• Software supply chain practices: artifact signing, registry governance and vulnerability management
• QA and testing infrastructure: static analysis and code quality gate enforcement in CI pipelines, automated end-to-end and browser-based regression test suites, ephemeral test environments for PR-based validation, and pre-merge quality checks
• Automation and tooling in Python or Go to improve infrastructure operations and integrate telemetry with observability platforms

What You’ll Need to Succeed

• Expertise in DevOps, SRE, or Platform Engineering in large scale cloud environments
• Expertise in deploying to cloud environments (AWS, GCP, etc) using infrastructure-as-code (Terraform, Helm) and containerization
• Deep experience with CI/CD systems (GitHub Actions, GitLab CI, or Jenkins) and GitOps practices
• Strong proficiency in Python/scripting languages for automation and tooling
• Strong understanding of Kubernetes operations: deployments, networking, storage, observability, and troubleshooting

Bonus Points For

• Experience with GitOps tools (ArgoCD, Flux)
• SRE practices: observability platforms, chaos engineering, incident management
• Securing ML/AI pipelines (model registries, training clusters, inference gateways)
• Experience in regulated/audit-heavy environments (SOC 2, ISO 27001)
• Supply chain security maturity: SBOMs, image signing, SLSA concepts
• Administering static analysis platforms (custom quality profiles, security hotspot triage) and scaling browser-based test suites across parallel CI environments
• Prior startup/high-growth experience balancing velocity with reliability

Your Impact at LILA

As a Principal Security Engineer focused on AI Security, you will define and drive the technical strategy for securing how AI is used across Lila's enterprise. You will operate as a senior individual contributor, partnering with IT and business teams to ensure safe and compliant adoption of AI tools and platforms.

While Lila builds AI-powered systems, this role is primarily focused on securing the use of third-party and internally deployed AI tools across the enterprise — ensuring sensitive data, intellectual property, and scientific workflows are protected as AI becomes deeply embedded in how work gets done.

What You'll Be Building

• Enterprise AI Security Strategy — Define and implement security controls and guardrails for the use of AI tools (e.g., LLM APIs, SaaS AI platforms, and internal AI services) across the organization.
• AI Gateway & Agentic Gateway Security — Design and implement AI gateway controls to manage and monitor access to external and internal AI systems. Secure agentic workflows by enforcing identity, authorization, tool-use constraints, and policy controls for autonomous or semi-autonomous agents.
• AI Red Teaming & Adversarial Testing — Conduct red teaming and adversarial testing focused on enterprise AI usage, including prompt injection, data exfiltration, jailbreaks, and abuse of connected tools and plugins.
• Data Protection for AI Usage — Develop and enforce controls to prevent sensitive data leakage through AI systems, including input/output filtering, data classification, tokenization, and secure handling of prompts, embeddings, and outputs.
• Multi-Layer AI Security (Network, Endpoint, Data) — Integrate AI security into existing enterprise security layers: network visibility and control over AI service access, API traffic inspection, and zero trust enforcement; endpoint security for developer machines, research environments, browsers, and plugins; data layer controls ensuring proper handling of sensitive data when interacting with AI systems.
• AI Threat Modeling (Enterprise Context) — Develop threat models focused on enterprise AI usage, including risks such as data leakage, prompt injection, model misuse, supply chain risks from AI vendors, and unauthorized agent actions.
• Vendor & Platform Security — Assess and guide secure adoption of third-party AI vendors and platforms, including evaluating data handling practices, model behavior, and integration risks.
• Incident Response for AI Usage — Define and support response approaches for AI-related incidents, such as sensitive data exposure, policy violations, or misuse of AI tools.
• Cross-Functional Technical Leadership — Partner with Legal, Compliance, IT, and Engineering to align AI usage with regulatory requirements, data governance policies, and responsible AI practices.
• Security Enablement — Contribute to internal guidance and education on safe AI usage, including secure prompting, data handling, and appropriate use of AI tools.
• Security Tooling & Implementation — Evaluate and implement tooling for AI security, including AI gateways, DLP integrations, monitoring solutions, and policy enforcement mechanisms.

What You’ll Need to Succeed

• 8+ years of experience in information security, with strong expertise in enterprise, cloud, or application security.
• Hands-on experience designing and implementing security controls in enterprise environments.
• Familiarity with AI/ML systems and how modern AI tools (LLMs, copilots, APIs) are used in practice.
• Experience with cloud platforms (AWS/GCP), SaaS security, and zero trust architectures.
• Experience with data protection technologies (e.g., DLP, data classification, access controls).
• Practical experience with threat modeling, red teaming, or adversarial testing.
• Strong communication and influence skills across technical and non-technical stakeholders.

Bonus Points For

• Experience securing enterprise use of LLMs, copilots, or generative AI platforms.
• Familiarity with AI gateways, prompt filtering, or model interaction controls.
• Experience evaluating or securing third-party AI vendors and APIs.
• Background in regulated environments (biotech, healthcare, defense, or government).
• Experience with browser security, endpoint controls, or SaaS security platforms.
• Knowledge of privacy-enhancing technologies or confidential computing.
• Contributions to AI/ML security research or community.

Your Impact at LILA

Lila is building AI Science Factories (AISFs) — highly automated, AI-directed labs that generate the proprietary experimental data powering our AI platform. As we scale from one AISF to many, the operational infrastructure that keeps those factories running is a first-class strategic capability.

The Director of Lab Operations & Maintenance Management (LOMM) owns the physical and logistical foundation of Lila's science operations: consumables and reagent supply chains, equipment asset management, CMMS management, waste coordination, space readiness, preventative maintenance (PM), first response equipment/instrument demand maintenance, and multi-shift logistics continuity.

This role will build out and manage Lila's Maintenance Management (MM) function from the ground up — hiring the initial team, developing best practices, and establishing the operational handoff as we mature and scale.

But this role is as much about building these systems as running them — you'll define the LOMM operating model, lead its expansion to new sites, drive AI-enabled innovation in how we manage lab resources, and author the standards that travel with every AISF we open.

You'll operate as a recognized authority on lab operations within Lila, partnering directly with VPs and senior leaders across Autonomous Science Platform (ASP), Finance, EHS, and Facilities. You'll be a principal contributor to the Blueprint program — the global deployment framework that defines how Lila builds and runs AI Science Factories at scale.

What You'll Be Building

Lab Operations Strategy & Operating Model

• Define and own the LOMM operating model across Lila sites — from single-shift pilot to multi-site, continuous operations
• Establish the systems, org structure, staffing model, and governance framework that enable LOMM to scale reliably
• Set and track operational KPIs (inventory accuracy, stockout rate, PM scheduling compliance, asset data integrity, ticket resolution time); use data to drive structured improvement cycles and report trends to ASP leadership

Consumables, Reagents & Supply Chain

• Own end-to-end supply chain continuity for all lab consumables, reagents, and PPE across all shifts and sites
• Design and govern the par-level inventory system, reorder triggers, cold storage management, and expiry tracking infrastructure
• Lead dual-source qualification strategy for high-risk consumables; build the satellite site supply chain playbook for future AISFs in support of the Blueprint project

CMMS & Equipment Asset Management

• Own CMMS strategy, selection, implementation, and long-term governance — accountable for data accuracy across all commissioned instruments and mobile assets
• Define asset tagging standards and location tracking protocols in alignment with Blueprint's asset taxonomy
• Own PM coordination across sites; ensure calibration access and instrument readiness for production operations

Maintenance Management— Build & Oversight

• Build out the Maintenance Management function from scratch in collaboration with Hardware & Controls Engineering (HCE) team: define the team structure, hire initial MM staff, and establish the operating model for instrument PM, calibration, and first-response troubleshooting
• Stand up a dedicated L1 (Level 1) maintenance support team as the first line of response for lab-floor issues across shifts: triage incoming requests, execute standard work (resets, swaps, basic mechanical/electrical checks, consumables replenishment for instruments as defined), and escalate efficiently to HCE- L2/L3 Sustaining Engineering, vendors, or Integration Automation Engineering when deeper troubleshooting or design changes are required
• Establish the escalation and handoff protocols between MM, LabOps, Research Operations (production team), and HCE/Automation; define the boundary between maintenance of commissioned instruments that are best serviced by MM and engineering modifications
• Explore and define the HCE onboarding/training model for MM technicians, including potential rotational program for cross-training and augmentation

AI Integration & Continuous Improvement

• Lead Lila's thinking on AI-enabled lab operations — evaluate, pilot, and scale intelligent solutions across inventory management, predictive reordering, asset tracking, and operational reporting
• Build a continuous improvement culture within LOMM: baseline metrics, run structured improvement cycles, and bring external best practices from the biotech/life sciences industry into Lila's operating model
• Define the innovation roadmap for LOMM in partnership with engineering and operations teams

Vendor & Logistics Management

• Own vendor relationships for all lab supplies and logistics within approved frameworks; partner with Finance on contract strategy for key suppliers
• Oversee lab-side receiving, intake, space readiness for new instrument deployments, waste and hazmat scheduling, gas management, and cold storage operations
• Manage LOMM support ticket system as the single intake for all lab supply, equipment, and space requests

Team Leadership

• Lead, grow, and develop the LOMM team across shifts and sites, scaling with each new site and shift expansion
• Build and lead the MM team as a direct report function — from first hire through a fully operational multi-site MM capability
• Define staffing models, hiring roadmaps, and capability development plans for both functions as they mature
• Build a team culture defined by operational rigor, proactive problem-solving, and continuous improvement

Blueprint Contribution & Multi-Site Scaling

• Author and own the LOMM chapter of Blueprint — documenting processes, system requirements, staffing models, and vendor frameworks so LOMM scales reliably to every new AISF
• Pilot the Site Launch Readiness Scorecard for each new facility; feed findings back into Blueprint standards
• Define the LOMM readiness criteria and pre-commissioning checklist for all future site launches

What You’ll Need to Succeed

• 12–15+ years of lab operations experience in a biotech or life sciences environment, with demonstrated strategic impact at the program or portfolio level
• Proven track record of defining and scaling lab operations systems — not just inheriting and running them; you've built operating models, established governance, and led functions through significant growth
• Deep expertise in CMMS selection, implementation, and governance — you've owned platform decisions and data accuracy programs, not just used the tool
• Experience building and leading teams across multiple functions, shifts, or sites — including hiring from scratch and developing operational capability in parallel with day-to-day execution
• Experience owning and successfully defending ISO 9001:2015 audits related to preventive maintenance (PM) and calibration programs (e.g., evidence packages, CAPAs, and auditor-facing readiness)
• Recognized as an authority in lab operations within your organization; comfortable operating as a peer to VPs and senior leaders and representing your function externally
• Strong strategic and systems-level thinking — you anticipate org-wide operational challenges and define the structures to solve them, not just the immediate fix

Bonus Points For

• Experience building or overseeing a Maintenance Management or instrument PM function — familiarity with IQ/OQ/PQ, calibration registries, MTBF tracking, and service vendor management
• Experience leading or partnering closely with field service / technical service teams (dispatch, SLAs, escalation models, parts logistics, and service performance management) in high-uptime environments
• Experience applying AI or intelligent automation to lab operations workflows (e.g., predictive inventory, automated asset tracking, AI-assisted reporting)
• Background in materials science, life science, and chemistry lab environments — familiarity with the specific consumables, reagents, handling requirements, and vendor landscape in those domains
• Experience supporting multi-shift or 24/7 lab operations
• Familiarity with QMS-adjacent environments (SOP document control, change control, training records)
• Experience contributing to a global site deployment or standardization program (playbook authorship, site launch readiness frameworks)

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

ABOUT PIONEERING MEDICINES

Pioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship’s innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship’s bioplatform companies. Within Flagship’s Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners’ R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.

Position Summary 

The Senior Director, Head of Toxicology will lead and build the toxicology function within Pioneering Medicines, defining and executing nonclinical safety strategies across a diverse and rapidly evolving portfolio. This role provides scientific and strategic leadership across both investigative and regulatory toxicology, supporting a broad range of therapeutic modalities. 

Working in a dynamic venture creation environment, you will collaborate closely with multidisciplinary teams to optimize candidate selection, guide preclinical development, and ensure regulatory readiness. This is a high-impact role requiring strong analytical thinking, scientific rigor, and clear communication, influencing programs from discovery through early clinical development. 

Key Responsibilities 

Functional Leadership & Capability Building 

• Lead, build, and scale the toxicology function, including internal team development and external partnerships  

• Define fit-for-purpose operating models spanning investigative and regulatory toxicology  

• Serve as the primary internal expert for nonclinical safety, ensuring quality, consistency, and scalability across the portfolio  

Portfolio & Program Strategy 

• Define and drive toxicology strategies across multiple programs and modalities   

• Translate findings into clear risk assessments, mitigation strategies, and IND/CTA-enabling plans  

• Enable transparent, data-driven decision-making by articulating risks, assumptions, and trade-offs to program teams  

• Oversee the design, execution, and interpretation of non-GLP and GLP toxicology studies  

• Partner cross-functionally (DMPK, pharmacology, CMC, clinical) to integrate safety into development strategy  

• Support diligence and evaluation of new programs within Flagship’s ecosystem  

External Partnerships & Regulatory 

• Build and manage a high-performing CRO and consultant network, ensuring quality, timelines, and cost efficiency  

• Leverage and contribute to the Flagship ecosystem, fostering knowledge sharing and collaboration across platform companies  

• Lead nonclinical regulatory strategy and documentation (INDs, IBs, briefing materials)  

• Ensure regulatory readiness through clear and scientifically robust safety narratives  

• Represent toxicology in regulatory interactions as appropriate  

Qualifications 

• PhD, DVM, or equivalent in Toxicology, Pathology, Pharmacology, or related field  

• ~10-15+ years of experience in nonclinical safety in biotech/pharma  

• Proven track record advancing programs through IND and into clinical development  

• Experience across multiple modalities preferred  

• Strong experience managing CROs and external collaborations  

• Experience leading or building a toxicology function or team, including management of internal scientists and/or external partners, is a plus  

Leadership Profile 

• Enterprise mindset; able to operate across a portfolio in a fast-paced, collaborative environment  

• Analytical and goal-oriented, with the ability to operate with urgency while maintaining high standards of scientific rigor and ethics  

• Strong communicator who can translate complex toxicology into clear, audience-appropriate risk assessments, from early-stage teams to large pharma partners  

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 - $280,000. 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.

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff!  This role will require onsite leadership in Cambridge, MA.

What you’ll do

• Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation.
• Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance.
• Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ).
• Establish and execute a comparability strategy for pivotal process changes.
• Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation.
• Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections.
• Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Development, Quality, Regulatory, Manufacturing, Clinical and Supply Chain) to execute on CMC deliverables for pivotal and commercial.
• Hire, mentor and develop a team of engineers, fostering a culture of trust, curiosity, scientific rigor, collaboration, and continuous improvement across a fast-paced performance driven environment.
• Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work.

What we’re looking for

• Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline with a minimum of 10 years experience in cell therapy process development (including >5 years late stage development), with at least 5 years in a leadership role.
• Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy manufacturing.
• Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation, including raw material selection for GMP manufacturing.
• In depth knowledge and experience with application of engineering principles, DoE and QbD approaches to enable bioreactor scale up and scale down model development.
• Experience with risk and root cause analysis and tools (e.g. FMEA, Ishikawa).
• Knowledge of cGMP, and quality and regulatory expectations for commercial cell therapy and/or biologics products.
• Experience supporting regulatory submissions, Q&A and audits/inspections.
• Experience supporting tech transfer of a cell therapy process to manufacturing.
• Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities.
• Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization.

What will separate you from the crowd

• > 10 years direct experience developing cell therapy processes from pre pivotal to commercial.
• Experience with optimizing protocols to generate stem cell derived islets
• Experience with PSC differentiation at >10 L in bioreactors
• Knowledge of media development including analytical tools to evaluate spent media and regulatory expectations for raw materials.
• Knowledge of process analytical technology (PAT) and analytical methods for deep characterization of stem cell derived products
• Strong track record of identifying and implementing novel cell therapy manufacturing technologies into GMP.

What you should know

• The base pay range for this position at commencement of employment is expected to be between $250,000 and $300,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

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.   

The Opportunity

The Senior Director, Trade & Channel Operations will be responsible for building Amylyx’s U.S. distribution and channel model from the ground up in preparation for a future commercial launch of our lead product candidate. This individual will architect the distribution strategy, create the operational infrastructure necessary for launch, and partner cross functionally to ensure Amylyx is fully prepared to commercialize with excellence. As a key member of the Market Access team, this role will influence launch readiness, customer service delivery, and ongoing performance across distribution partners.

Responsibilities

• Design and build Amylyx’s U.S. distribution model across specialty pharmacy, specialty distributor, and 3PL channels to support product launch
• Lead contracting strategy for specialty pharmacies and distributors, including negotiating distribution and service agreements, fee schedules, data requirements, and service levels
• Integrate distribution channels with service programs and field initiatives to enable a seamless customer experience
• Collaborate with Supply Chain and Finance to support 3PL operations, including order‑to‑cash processes, inventory management, data exchange, shipping, returns, and chargeback management
• Establish and manage noncommercial and free‑goods pharmacy operations
• Forecast and model channel performance, assess specialty pharmacy throughput, and provide recommendations to ensure timely, reliable patient access
• Develop distribution analytics including inventory visibility, service metrics, dispense data, time to therapy, and partner scorecards; lead specialty pharmacy QBRs
• Partner cross‑functionally with Supply Chain, Quality, Compliance, Legal, Finance, Patient Services, and Commercial Operations to ensure operational alignment and launch readiness
• Serve as a senior leader within Market Access, contributing to launch planning, forecasting, patient access workflows, and overall distribution strategy
• Continuously optimize post‑launch distribution operations by driving root‑cause remediation, vendor KPI management, and process improvements informed by field and service feedback.

Required Qualifications

• Bachelor’s degree required
• 12+ years of experience in biopharmaceutical trade and distribution, including leadership of specialty pharmacy and distributor channel networks
• Prior product launch experience in the US market
• Experience designing and implementing channel strategies for product launches
• Proven ability to assess, manage, and influence channel partner performance to contractual expectations
• Hands‑on experience with 3PL operations, serialization, state licensing, and compliant distribution processes
• Demonstrated strength in contract negotiation, vendor management, and commercial channel operations
• Deep understanding of payer reimbursement, hub/patient support integration, channel economics, and order‑to‑cash workflows
• Proven leadership experience, including managing large pharmaceutical vendors, with demonstrated people management skills
• Excellent communication, vendor management, analytical, and project execution capabilities

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.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

The Role:

Reporting to the Associate Director, Formulation Sciences, the Senior Manager, Formulation Sciences will act as late-stage drug product subject matter expert and will support drug product process validation toward commercialization. The successful candidate needs to demonstrate a proven record of working in a virtual environment with CDMOs to deliver clinical and commercial supplies in support of fast-paced late-stage development programs. Using strategic thinking, the Senior Manager must be able to develop and execute process validation strategies for successful product commercialization.

This individual has responsibility for support of drug product process validation, scale up, and post-approval changes (SUPAC) and routine commercial manufacturing activities across Nuvalent’s contract research and manufacturing organizations. The primary accountability is being the steward for product development and manufacturing as these programs transition through development and into commercialization. The ultimate goal will be to ensure robust process and manufacture strategies for consistent commercial supply.

Responsibilities:

• Support drug product Process Validation activities, Scale up and post-approval changes (SUPAC) and routine commercial manufacturing at CDMOs.
• Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality.
• Draft, coordinate, execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions.
• Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc.
• Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes).
• Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables.
• Provide support for technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc.
• Familiar with statistical analysis software, such as JMP.
• Perform process capability analysis, identify risk, and make recommendations for process improvement.
• Manage documentation, change controls, material inventory, product complaints, and deviation resolution at CDMOs.
• Represent the drug product group as a Subject Matter Expert to support audits and regulatory inspections.

• Support authoring the relevant technical sections of regulatory filings.

• Support late-stage validation and post-approval readiness activities and commercial manufacture activities within a virtual working environment.

Competencies:

• Strong organizational, planning, and multitasking skills in a fast‑paced environment.
• Excellent relationship‑building and communication skills across diverse teams.
• Evidence of effective cross‑functional collaboration with both internal teams and external partners.
• Strong problem‑solving and analytical skills with the ability to break down complex issues.
• Results‑driven mindset with attention to quality and timelines. A strong understanding and knowledge of cGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required.
• Excellent organization and multi-tasking skills.
• Experience building positive and effective cross functional relationships and the ability to align stakeholders, both internally and externally to Nuvalent.

 Qualifications:

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering or related field with a minimum of 3+ years or MS with 6+ years /BS with 10+ years of industry experience.
• Proven track record on drug product process validation, scale up and manufacture for solid dosage form (tablets).
• Experience with QbD principles and DOE methodology preferred.
• Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals.
• Understanding of cGMP/ICH guidelines and the ability to apply them to development and manufacturing.

• Experience with solid dosage form (tablet) process development; exposure to late-stage validation is a plus.

• Ability to author and critically review relevant development reports as well as regulatory dossiers.
• Up to 25% travel is expected, both domestically and internationally.

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

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.

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As an MSAT Associate Director, you will report to the Executive Director of MSAT to support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead an MSAT team responsible for the pancreatic cell maturation and aggregation process to generate DP at an external manufacturing partner. You will define and execute the technology transfer strategy in alignment with program timelines. Your team will provide technical coverage at the external manufacturing partner throughout the phase I manufacturing campaign including people-in-plant, executed batch record review, investigations, and batch summaries. You will collaborate with internal partners across Quality, External Manufacturing, and Supply Chain to complete batch disposition. You will draft applicable CMC sections of regulatory documents (IND module 3).  You will provide your team members with technical guidance and mentorship.   

What you’ll do

• Lead a team of 1-2 individuals supporting phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical team to achieve phase I manufacturing readiness and address manufacturing challenges
• Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
• Draft CMC sections for regulatory filings (IND module 3) and other technical documents
• Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements
• Lead investigations and troubleshoot process execution challenges by applying root cause analysis
• Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• BSc. in Chemical, Biological, or Biomedical Engineering plus 8 yrs or equivalent combination of education and work experience
• >3 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and experience working in a regulated environment, including as person-in-plan and/or GMP operator/supervisor
• Experience operating perfusion bioreactors and with fill/finish unit operations
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >2 direct reports
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

What will separate you from the crowd

• Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials including PBS bioreactor
• Familiarity with cell therapy drug product development, including stability studies
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom
• Knowledge of single-use technologies applicable to cell therapies
• Experience with process closure and automation
• Understanding of analytical methods such as flow cytometry
• Familiar with data analysis tools such as R, Python, JMP and FlowJo software

What you should know

• Travel to the manufacturing site ~25% of the time (Texas)
• Some weekend work required
• Lift up to 25 lbs
• Work within a cleanroom environment
• The base pay range for this position at commencement of employment is expected to be between $170,000 and $210,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As an MSAT Director, you will report to the Executive Director of MSAT and support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead an MSAT team responsible for the PSC seed train and differentiation to beta cells at an external partner. You will define and execute the technology transfer strategy in alignment with program timelines and provide your team with technical mentorship. Your team will provide technical coverage at an external manufacturing partner throughout the phase I manufacturing campaign including people-in-plant, executed batch record review, investigations, and batch summaries. You will collaborate with internal partners across Quality, External Manufacturing, and Supply Chain to complete batch disposition. You will draft applicable CMC sections of regulatory documents (IND module 3). 

What you’ll do

• Lead a team of 2-4 individuals supporting Phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical team to achieve manufacturing readiness and address technical challenges
• Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
• Author CMC sections for regulatory filings (IND module 3) and other technical documents
• Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements
• Lead investigations and troubleshoot process execution challenges including root cause analysis
• Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• BSc. in Chemical, Biological, or Biomedical Engineering plus 10 yrs or equivalent combination of education and work experience
• >5 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >3 direct reports
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

What will separate you from the crowd

• Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials including cryopreservation
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom
• Understanding of analytical methods such as flow cytometry
• Experience with cell therapy process closure and automation
• Knowledge of single-use technologies as applicable to cell therapies
• Familiar with data analysis tools such as R, Python, JMP and FlowJo software

What you should know

• Travel to the manufacturing site ~25% of the time (Canada)
• Some weekend work required
• Lift up to 25 lbs
• Work within a cleanroom environment
• The base pay range for this position at commencement of employment is expected to be between $200,000 and $250,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

An opportunity has arisen for a Supply Chain Operator within our Cambridge based Operations team. This role is responsible for delivering all aspects of an efficient end-to-end supply chain within Operations, including kit assembly, goods in/out, warehousing customer service and inventory management, whilst providing additional support to projects and continuous improvement initiatives.

What you’ll be doing for us

To work as part of a team in executing tasks as directed by the Finished Goods Supervisor including, but not limited to, the following activities:  

• Final product assembly
• Maintain Dangerous Goods and Dry Ice certification
• Print and reconcile version-controlled documents and labels confidently and independently
• Monitor and maintain tock levels of materials and reagents within the kit assembly area, identify and raise order requisitions and/or material requests for replenishment
• Oversee and ensure the maintenance of cleanliness and organisation of the kit assembly and dispatch areas, bench areas and fridge/ freezers
• Raise Material Transfer Form requests to replace stock as necessary
• Assist with Materials Management tasks as directed, including the selection, and picking of warehouse items using the MRP system
• Assist, when required, with creating packing sheets, adding stock entries and keying orders into the SAGE accounting system
• Provide support across various Supply Chain functions including kit packing, dispatch, goods in processing and general warehouse operations
• Liaise with Customer Services to ensure customer orders are fulfilled, prepared and dispatched on time
• Execute and document tasks using approved ISO compliant documentation
• Adhere to procedures documented in the Cytocell quality system and ensuring that any non-compliance noted is reported in a timely manner using approved procedures
• Ensuring safety related issues are reported, including completion of relevant documentation
• Write and update SOP’s BMR’s and other documentation as required
• Working within the dispatch area, liaising within Customer Services to ensure customer orders are fulfilled, prepared and dispatched on time
• Pro-actively seek out and identify opportunities for process improvements and make recommendations to Supervisory Team
• Collaborate with internal and external partners to drive the sustainable agenda along the entire supply chain
• Collaborate with cross-functional scientific, laboratory and R&D teams that include a diverse range of personalities and skills.

To provide support to other areas of operation as required:

• Complete tasks as commensurate with the level and nature of the post as delegated by the Finished Goods Supervisor
• Assist when required with warehouse goods-in and material transfer processes and update inventory systems accordingly
• Maintain accurate inventory records and ensure warehouse inventory levels are optimized to meet manufacturing demand while minimizing carrying costs
• Identify and investigate any inventory discrepancies or issues and implement corrective actions.

What we are looking for in you

Essential

• Knowledge and experience of working within ISO and GMP environments
• Growth mindset – actively searching out opportunities for improvement, simplification and reduction in waste
• Right first time - strong attention to detail and excellent organisational skills
• Effective written and verbal communication abilities
• Ability to work collaboratively in a team
• Ability to prioritize tasks and work well in a fast-paced environment
• Computer literacy
• Ability to be in the office 5 days per week.

Desirable

• Knowledge and experience of customer service, ERP export, dispatch and production processes
• Knowledge of requirements of ISO9001 & ISO13485.

In return you’ll receive:

• Competitive salary
• Pension Scheme (10% non-contributory)
• Private Health Insurance
• Private Dental Insurance
• Group Income Protection
• Group Life Assurance
• 25 days holiday plus UK bank holidays
• High Street Discount Scheme.