Lead Validation Engineer Responsibilities:

• Lead second shift CQV execution activities across multiple systems and workstreams
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines
• Interface with QA, Engineering, and Operations to resolve issues in real time
• Oversee execution of IQ/OQ protocols and operational verification activities
• Support and review: 
  • Drawing walkdowns
  • Equipment and component verification
  • Materials of Construction (MOC) and weld verification
• Provide oversight for temperature mapping and validation activities
• Support SIP/CIP and related cycle development activities as needed
• Ensure all documentation meets GMP/GDP and audit-ready standards
• Drive deviation identification, escalation, and resolution

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 8+ years of CQV/validation experience in pharma or biotech
• Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
• Proven experience leading validation teams or shift-based execution efforts
• Strong GMP/GDP knowledge
• Experience with eVal (required), ValGenesis a plus
• Experience with temperature mapping (Ellab a plus)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

This role requires the ability to be on-site, full-time in Devens, MA.

Senior Validation Engineer Responsibilities:

• Execute IQ/OQ protocols and support operational verification activities
• Perform Drawing walkdowns (P&IDs, system verification)
• Perform Equipment/component verification
• Perform MOC and weld verification
• Support temperature mapping activities using data loggers and validation tools
• Assist with SIP/CIP execution and cycle development activities
• Identify and document deviations and support investigations
• Ensure accurate and complete documentation in compliance with GMP/GDP standards
• Work collaboratively with engineering, QA, and operations teams

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 3–8 years of CQV/validation experience
• Hands-on experience executing validation for process equipment
• Strong GMP/GDP fundamentals
• Experience with IQ/OQ execution and field verification activities
• Experience with eVal (required), ValGenesis a plus
• Exposure to temperature mapping (Ellab a plus)
• Experience with bioprocess equipment preferred (bioreactors, filtration, chromatography, UF)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

This role requires the ability to be on-site, full-time in Devens, MA.

About Every Cure:   

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker,  New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H. 

 Our approach:  

• AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.  
• Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.  
• High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.  
• Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.  
• Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement  and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

• Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
• Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
• Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

• Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
• Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
• Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
• Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

• Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
• Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
• Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

• Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
• Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
• Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

• Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
• Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
• Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
• Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education 

• MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

• Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
• Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
• Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
• Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
• Experience working across more than one therapeutic research area.
• Experience with small-sample trial designs and natural history or registry data.
• Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

• 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills 

• Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
• Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
• Exceptional communication and presentation abilities.
• Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
• Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
• Strategic thinker with a focus on urgency, efficiency, and impact.
• Passionate about Every Cure’s mission and values.
• Highly adaptable, thriving in a fast-paced, start-up environment.
• Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits: 

• Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually. 
• Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses. 
• Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future. 
• Relax and recharge: Generous time off, including paid time off and paid holidays. 
• We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times. 

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.  

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

Job Title:  Senior Product Marketing Manager
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $145,000 - $175,000 + variable + equity options
*compensation may be negotiated based on experience level

The role

As a Senior Product Marketing Manager, you'll define and scale how the world understands Ketryx and ensure our story translates into sales wins and customer advocacy. You'll be a master communicator and writer who transforms complex technology into clear, compelling narratives. You'll be the strategic partner our sales team relies on to win deals and the voice that turns our customers into champions.

You'll be joining a company tackling one of the hardest challenges in technology: helping life sciences teams safely and compliantly build regulated products fast. Our platform sits at the intersection of AI, developer tooling, and regulatory infrastructure, serving customers whose products impact hundreds of millions of patients each year. That responsibility and complexity demand excellence, and your job is to demonstrate that Ketryx is the only platform that delivers.

This is a high-visibility, high-impact role where success means transforming complexity into clarity, enablement into revenue, and customers into advocates. You'll work directly with the CMO, Product leadership, Sales leadership, and Customer Success to ensure our narrative is clear, our sales team is equipped to win, and our customers become our best marketers.

About you

You're an exceptional communicator and writer first and foremost. You communicate with precision, clarity, and impact across every format and make complex ideas simple, memorable, and actionable. You think strategically and build frameworks that scale. You're analytical and structured, comfortable leading without authority and influencing senior stakeholders. Your assets are the ones sales teams actually use and customers actually read.

You're a sales enablement expert who knows how to equip teams to win. You've built training programs, battlecards, and playbooks that measurably improved sales performance. You're also skilled at customer marketing and love creating compelling customer stories, building reference programs, and activating advocates.

If you want to shape how the world understands a category-defining product, equip a sales team to win, and turn customers into champions through exceptional communication, we'd love to meet you.

Responsibilities

• Shape how Ketryx shows up in the market. Own messaging and positioning that transforms complex technology into clear, compelling narratives that differentiate and resonate.
• Build the sales enablement engine. Create battlecards, training programs, and playbooks that equip our sales team with the confidence and tools to win consistently.
• Drive customer marketing and advocacy. Develop compelling case studies, build reference programs, and activate customers as champions who amplify our story.
• Bring new products and features to life. Partner with Product, Sales, and Demand Gen to execute launches that create buzz, generate pipeline, and drive adoption.
• Keep us sharp on the market. Research customers, competitors, and industry trends to uncover insights that shape our messaging, product strategy, and positioning.
• Measure what matters. Track and report the impact of enablement, launches, and customer programs, connecting your work directly to revenue growth and market momentum.

Required Skills

• Exceptional writing and communication skills - ability to produce clear, compelling, and technically accurate content across formats (decks, web pages, case studies, training materials, battlecards, blogs).
• 7+ years of product marketing experience - ideally 5+ years in B2B SaaS, with demonstrated progression to senior or lead-level ownership.
• Sales enablement expertise - built and delivered enablement materials with clear, measurable impact on sales performance.
• Strong technical storytelling ability - translates complex, technical, or regulated concepts into simple, differentiated market narratives.
• Process-builder mindset - experience creating scalable product marketing frameworks, templates, and operating rhythms from scratch.
• Data-informed decision making - uses customer, market, and performance insights to refine messaging and go-to-market strategy.
• Execution ownership in high-velocity environments - consistent track record of driving projects end-to-end in startup or fast-growing companies.

Preferred Skills

• Strongly Preferred: STEM background or proven knowledge or experience in one of the following:
• Life Science SaaS
• Software/Product Lifecycle Management
• Software testing / Verification and Validation
• Artificial intelligence (AI/ML)
• Cybersecurity
• Medical device or software as a medical device (SaMD)
• Experience with sales enablement platforms (Highspot, Seismic, Gong, Chorus).
• Experience building customer advisory boards or reference programs at scale.
• Public speaking or webinar moderation experience.
• Experience working in an early stage, product-based start up.

Keywords: Technical product marketing, product marketing manager, healthcare technology, medical devices, AI/ML, FDA regulations, software validation, B2B SaaS marketing, solutions engineering, life sciences, medical device software, regulatory compliance, go-to-market strategy, healthcare software, biomedical engineering

Job Title: Product Marketing Manager
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $110,000 - $120,000 + variable + equity options
*compensation dependent on related experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

About the Role:

As a Product Marketing Manager, you’ll define how the world understands Ketryx. You’ll shape our story, translating complex technology into clear and compelling narratives that drive the go-to-market strategy, campaigns, and product launches. 

You’ll be joining a company tackling one of the hardest challenges in technology: helping life sciences teams safely and compliantly build regulated products fast. Our platform sits at the intersection of AI, developer tooling, and regulatory infrastructure, serving customers whose products impact hundreds of millions of patients each year. That responsibility and complexity demand excellence, and your job is to demonstrate that Ketryx is the only platform that delivers.

This is a high-visibility, high-impact role where success means transforming complexity into understanding, and understanding into adoption. By joining the product marketing team, you’ll have the support of a team of subject matter experts and the runway to build repeatable playbooks that scale as we grow.

Responsibilities:

• Shape how Ketryx shows up in the market. Transform complex concepts into clear, compelling messaging and positioning.
• Bring new products and features to life. Partner closely with Product, Sales, and Demand Gen to plan and execute launches that create real buzz and generate pipeline.
• Create content that drives action and thought leadership. Build the decks, one-pagers, web pages, webinars, and case studies that bring our story to life, fuel sales conversations, and strengthen Ketryx’s leadership.
• Empower our go-to-market teams. Build and deliver training, playbooks, and enablement materials that give BDRs and AEs confidence, clarity, and the tools to win.
• Keep us sharp on the market. Research customers, competitors, and industry trends to uncover insights that shape our messaging, product strategy, and positioning.
• Measure what matters. Track and report the impact of launches, content, and enablement initiatives, connecting your work directly to revenue growth and market momentum.

Required Skills:

• 5+ years of experience in product marketing or product management with 3+ years in B2B SaaS environment
• Experience developing clear, audience-specific messaging and product narratives that translate complex, technical, or regulated concepts into simple, compelling stories.
• Experience designing and delivering effective sales enablement, including competitor battlecards, objection handling, sales presentations, and training.
• Proven track record using data and market insights to refine messaging and strategy
• Hands-on experience building a range of marketing assets, sales presentations, demo videos, 1-pagers, web pages, blogs, and webinar content.
• Consistent track record in defining/driving project execution in a start-up environment.

Preferred Skills:

• Strongly Preferred: STEM background or proven knowledge or experience in one of the following:
• Life Science SaaS
• Software/Product Lifecycle Management
• Software testing / Verification and Validation
• Artificial intelligence (AI/ML)
• Cybersecurity
• Medical device or software as a medical device (SaMD)
• Experience working in an early stage, product-based start up.

Keywords: Technical product marketing, product marketing manager, healthcare technology, medical devices, AI/ML, FDA regulations, software validation, B2B SaaS marketing, solutions engineering, life sciences, medical device software, regulatory compliance, go-to-market strategy, healthcare software, biomedical engineering

Position Summary:

The Director of Scientific Communications & Evidence Generation will be responsible for developing a plan for disseminating the company’s scientific data (manuscripts, abstracts, posters, presentations); as well as identifying clinical evidence gaps, overseeing non-registrational research, and collaborating with cross-functional teams to generate real-world evidence (RWE), health economics and outcomes research (HEOR), and investigator-sponsored research (ISR) to support product value and safety profiles. This role requires strong scientific writing skills, advance understanding of industry best practices related to publication-related and research-related compliance, as well as cross-functional leadership savvy.

Key Responsibilities:

Scientific Communications & Publication Planning

• Develop and maintain and 18-month publication plan and lead the publication review process (abstracts, posters, oral presentations, manuscripts, review articles, etc) in compliance with GPP (Good Publication Practice) and ICMJE authorship criteria, as well as data transparency, and fair balance.
• Utilize innovative formats (micro‑learning, interactive pathways, patient‑friendly visuals) and ensure accessibility for diverse audiences
• Maximize the scientific impact of company data via the strategic selection of journals and congresses
• Collaborate with internal/external expertsand vendors to draft content and ensure the scientific accuracy of all data to be presented.
• Maintain the enterprise scientific lexicon and core claims matrix; ensure consistency across materials and channels.

Data Generation: 

• Lead the development of an integrated evidence generation plan (IEGP) aligned with overall medical affairs goals to address unmet needs in collaboration with Clinical Development, Regulatory, HEOR, and Commercial teams to avoid duplicative efforts. 
• Evaluate and acquire new data sources (clinical trials, RWD, registries) to support evidence plans.
• Create processes for synthesizing feedback from various sources, including field insights and advisory boards and analyze the data to uncover trends and actionable insights to guide scientific communication and strategic decision-making designed to effect change.
• Conceptualize and execute non‑promotional education for multidisciplinary audiences (hematology, BMT/transplant, apheresis, transfusion medicine, genetic counseling, nursing), including webinars, symposia, workshops, and digital learning modules.
• Establish content measurement frameworks (reach, engagement, knowledge lift, practice intent) and continuous improvement loops.
• Provide operational management for Medical Affairs-led research, including RWE, HEOR, and ISR, including monitoring the contractual commitments of vendors and collaborators to ensure quality and timeline adherence.
• Ensure all evidence generation activities follow ICH-GCP guidelines, SOPs, and compliance requirements for post-marketing research.

Cross‑Functional Partnership

• Collaborate within Medical Affairs and with Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, and Patient Advocacy to ensure accuracy and balance across communications.
• Develop and deliver scientific training programs for internal teams (e.g., onboarding for MSLs/field medical; refresher modules on gene therapy mechanisms, safety monitoring, LTFU requirements)..

Associated Responsibilities:

• Own Med Affairs content as well as related SOPs and work processes.
• Ensure adherence to policies and procedures via audits.
• Develop and deliver monthly and quarterly updates to track progress and align on key priorities.
• Develop and manage department budget
• Lead or co‑lead medical review for scientific materials; partner with Legal/Compliance/Regulatory on clear SOPs and guardrails.

Qualifications:

• MD, PharmD, PhD in a biomedical field; experience in hematology or Oncology or cell and gene therapy strongly preferred.
• 8+ years in Medical Affairs/Scientific Communications within biopharma, including publication planning and medical education leadership.
• Understanding of hemoglobinopathies (SCD, β‑thalassemia), cell‑based gene therapy modalities, safety monitoring (including long‑term follow‑up), and registry/RWE experience is preferred
• Experience building omnichannel education programs.
• Fluency with compliance frameworks (GPP, ICMJE, ACCME, OIG, PhRMA Code) and medical review processes.
• Exceptional scientific writing, editorial judgment, and stakeholder management; comfortable engaging with KOLs, investigators, and advocacy leaders.

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

About the Opportunity

We are seeking a highly skilled Machine Learning Scientist to drive the development and translation of cutting-edge ML models that have a direct impact on the care pathway for heart disease diagnosis and prognosis. In this role, you will collaborate with ML scientists, data engineers, biostatisticians, regulatory experts, and senior leadership to understand clinical requirements, develop innovative solutions, and support product development and regulatory approvals. You will also engage in high-impact research collaborations with world-renowned academic and medical institutions.

Responsibilities

• Research and develop state-of-the-art machine learning models for coronary CT angiography imaging applications.
• Conduct rigorous analysis and validation of machine learning algorithms and prototypes.
• Explore novel methods for processing and analyzing large, complex medical imaging datasets.
• Collaborate with engineering teams to deploy ML algorithms in clinical practice.
• Present research findings, insights, and recommendations to internal stakeholders and external collaborators.
• Author scientific publications and contribute to patent development.
• Manage collaborative research projects with leading academic partners.

Requirements

• Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field; OR an M.S. with 5+ years of relevant experience.
• Strong theoretical and practical expertise in image science, applied mathematics, machine learning, and deep learning.
• Research experience in applying ML and deep learning techniques to medical image processing, including segmentation, registration, classification, reconstruction, and detection.
• Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis).
• Proficiency in Python, with experience handling large datasets, implementing ML pipelines, and visualizing analysis results.
• Ability to translate complex clinical requirements into machine learning solutions.
• Strong critical thinking, problem-solving, and project management skills.
• Excellent interpersonal, cross-functional, and cross-cultural collaboration skills.

Preferred Qualifications: 

• 2+ years of postdoctoral research or industry experience.
• Hands-on experience in developing and applying advanced deep learning models, including vision transformers, semi-supervised/self-supervised/unsupervised learning, incremental learning, and continuous learning techniques.
• Strong domain knowledge in CT imaging and its clinical applications.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $186,000 - $212,000
• TTC: $214,000 - $245,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Job Title: Associate Director / Director, Device Development (Prefilled Syringes & Auto-Injectors)

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered. 

Position Summary

We are seeking an experienced and driven Associate Director or Director of Device Development to lead the end-to-end development of drug delivery systems, with a focus on prefilled syringes and auto-injectors for late-stage programs and commercialization.

This role will be responsible for integrating medical device engineering, human-centered design, and human factors engineering into combination product development, ensuring safe, effective, and patient-friendly delivery solutions. The ideal candidate brings deep expertise in biomedical engineering, device development, and regulatory requirements for combination products, along with a track record of advancing programs from clinical stages through commercial launch.

Key Responsibilities

Device & Combination Product Development

• Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization
• Define and execute device development strategies, including design, verification, validation, and lifecycle management
• Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies

Human-Centered Design & Human Factors Engineering

• Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs
• Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies
• Ensure compliance with FDA, EMA, and global HFE/usability requirements

Technical Leadership

• Provide subject matter expertise in biomedical engineering and device technologies
• Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing
• Independently manage external partners, including device manufacturers, design firms, and testing laboratories

MSAT & Manufacturing Support

• Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages
• Serve as Person-in-Plant (PIP) during manufacturing campaigns, ensuring on-site technical oversight and rapid issue resolution
• Lead and support manufacturing campaigns, including engineering runs, clinical, PPQ, and commercial production
• Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up
• Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing

Regulatory & Quality

• Support regulatory submissions (e.g., IND, BLA) with device-related content
• Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971)
• Partner with Quality to ensure design controls and risk management processes are implemented effectively

Qualifications

Education

• PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field

Experience

• Associate Director: 8+ years of relevant experience
• Director: 12+ years of relevant experience
• Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors
• Proven track record supporting late-stage development and commercialization

Technical Expertise

• Strong knowledge of:
• Medical device design and development processes
• Human factors engineering / usability engineering
• Risk management
• Design controls and validation requirements
• MSAT and manufacturing support for combination products
• Experience with biologics delivery systems preferred

Leadership & Collaboration

• Demonstrated ability to lead cross-functional, matrixed teams
• Strong communication skills with experience influencing senior leadership and external partners
• Strategic mindset with the ability to balance technical depth and business objectives

Preferred Qualifications

• Experience with regulatory interactions (FDA, EMA) for combination products
• Background in patient-centric design
• Experience with commercial device manufacturing and supply chain management

Additional Requirements

• Ability to travel up to 20%, including visits to manufacturing sites, external partners, and testing facilities

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

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

What You’ll Do:

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization
• Build and execute project plans with clearly defined risks and milestones
• Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements
• Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements
• Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
• Drive design verification and validation activities, including test method development, protocol execution, and documentation
• Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
• Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
• Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities
• Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
• Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing
• Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File
• Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366

Required Qualifications:

• Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role
• Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions
• Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
• Strong knowledge of applicable regulatory standards and guidance documents
• Excellent communication, leadership, and cross-functional collaboration skills

Preferred Qualifications:

• Experience working in a regulated pharmaceutical or biotech environment
• Familiarity with combination product regulations (21 CFR Part 4)
• Experience with supplier management of external development, testing, and manufacturing partners
• PMP certification or formal project management training is a plus

Education:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.

Staff Data Scientist, Graph ML

About Us Valo Health is a technology company applying human and machine intelligence to accelerate the creation of life-changing medical treatments. At the core of this vision is Valo’s computational platform: an end-to-end, integrated drug discovery and development engine built from the ground up. Valo hires the best and gives them first-class training and support. We approach our work fearlessly, learn quickly, improve constantly, and celebrate our wins. A centerpiece of our culture is our commitment to inclusion across race, gender, age, religion, identity, and experience. Diversity fuels the Valo experience and drives us every day. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

As Staff Data Scientist, Graph ML, you will develop and deploy graph ML solutions to synthesize and extract novel insights from Valo data in the context of a vast corpus of knowledge in medicine, molecular biology, human genetics, and drugs, to drive compute-enabled biological hypothesis generation. Our innovative platform leverages advanced computational techniques, starting with patient data, to bring better medicines to patients, faster. You will be responsible for developing and delivering graph ML and network biology-based analyses that generate and support drug target hypotheses on the path to discovery of new medicines. You will collaborate closely with a diverse group of data scientists and biologists to enable the contextualization of predicted drug targets within relevant patient subpopulations. You will also be accountable for communicating methodological approaches and key results to internal and external cross-functional stakeholders. Additionally, you will work with other data scientists, software engineers, and data engineers to continue building and improving Valo’s integrated graph platform to accelerate insights across multiple projects and applications.

A successful candidate brings deep technical expertise in graph machine learning, network analytics, and modern data science best practices, along with experience in biology research in the context of drug discovery, and curiosity and excitement to learn.

What You’ll Do…

•  Lead the design, implementation and application of graph ML and network biology approaches to target discovery from RWD and multi-omic datasets.
• Prototype new approaches aimed at enhancing and improving Valo’s graph platform, seeking out new scientific opportunities to increase the team’s impact.
• Work with world-class engineers to ensure that graph methodologies, graph construction, and underlying data are robustly integrated, to develop generalizable solutions to core scientific problems.
• Apply your technical knowledge and intuition to break down large problems into solvable pieces. Time is limited; you’ll need to prioritize which problems are critical-path today from those that can wait.
•  Be an agile and pro-active Data Science team member, providing regular updates on your work, and input into the work of your colleagues; championing data science best practices; participating in code, design, and analysis review.

What You Bring…

•  MS or PhD in a quantitative field with extensive experience at the intersection of machine learning and graph analytics
•  Experience in healthcare, medicine, molecular biology, computational biology, or life sciences.
•  Advanced knowledge of and experience with graph ML techniques such as Graph Neural Network (GNN) models applied to link prediction, node classification, and other biomedical-relevant computational tasks, as well as related explainability methods
• Experience or general knowledge of knowledge-graph building and graph databases
•  Familiarity with general graph algorithms and relevant Python libraries
• Strong experience in Python and machine learning and/or deep-learning frameworks (e.g., pytorch)
• Experience with data science best practices (data provenance, code versioning, reproducibility, git, etc), large-scale data analytics engines (e.g., Spark or Dask), and working in cloud environments (e.g., AWS)
• Strong data visualization, analytical, problem-solving, and communication skills, with demonstrated ability to condense, summarize, and synthesize results into informative and actionable presentations to experts from different fields.

Nice to have…

•  Experience with traditional drug discovery and development processes and approaches
• Domain expertise in neuroscience, immunology, and/or cardio-metabolic biology
•  Knowledge of related data science domains, including statistical genetics, multi-omics & real-world evidence