Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Standing for full shift
Job DescriptionThis position is part of Chemistry, Manufacturing and Controls (CMC) Development team and part of Manufacturing Science and Technology (MSAT).
Job Title: Staff Scientist - Process Validation & Technology TransferLocation: US - Massachusetts - Plainville | 100% onsite
Division Specific Information: Pharma Services | Large Molecule
How will you make an impact? As Staff Scientist, you will own process validation strategy and lifecycle execution for biologics and viral vector programs at our Plainville site, and serve as technology transfer lead for incoming client and internal programs. In this role, you will:
- Provide technical and organizational leadership for Process Validation (PV), Continued Process Verification (CPV), technology transfer, and lifecycle management.
- Own validation strategy execution, regulatory compliance, documentation readiness, and operational support for both clinical and commercial programs.
- Partner cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Supply Chain to drive compliant, efficient, and scalable process validation and documentation practices.
- Establish and maintain site SOPs, policies, and standards aligned with global procedures and regulatory requirements.
- Provide technical oversight for validation impact assessments and risk-based process decisions.
- Author, execute, and approve validation deliverables including Stage 1 process characterization and control strategy documents, PPQ protocols and reports, hold-time and mixing studies, aseptic process simulations, and shipping validation.
- Partner with Process Engineering and Manufacturing to support deviation investigations, change controls, and lifecycle management activities.
- Support regulatory submissions and responses through technical documentation review and validation justification.
- Serve as technology transfer lead for programs moving from internal process development or client sites into GMP manufacturing
- Manage validation documentation timelines to ensure on-time delivery aligned with program milestones.
- Collaborate cross-functionally and with clients to align on validation strategy and technical direction.
- Manage multiple concurrent program lifecycles and ensure prioritization aligned with business objectives.
- Communicate technical risks, mitigation strategies, and performance metrics to senior leadership and client.
- Lead initiatives to enhance validation efficiency, reduce documentation cycle times, and improve CPV data visibility.
Education & ExperienceB.S. in Chemistry, Biochemistry, Chemical or Biochemical Engineering, or a related field with 8+ years of industry experience; M.S. with 6+ years; or Ph.D. with 4+ years.
Experience must include process validation in a cGMP biologics or cell and gene therapy environment, with at least 2 years in a technical leadership or program-lead capacity. CDMO experience preferred.
Knowledge, Skills, Abilities- Demonstrated expertise in process validation and CPV program development.
- Deep understanding of biologics and viral vector (AAV, lentiviral) manufacturing processes across upstream, downstream, and drug product, including single-use technologies and aseptic fill/finish.
- Strong working knowledge of FDA, EMA, and ICH guidance and cGMP requirements, including FDA Process Validation guidance, ICH Q8-Q11, EU GMP Annex 1, and applicable cell and gene therapy guidance.
- Expertise in lifecycle process validation (Stage 1-3), CPV, and control strategy development.
- Working proficiency in statistical methods and tools used for validation and CPV - sampling plan justification, capability indices, control charting, and trending in JMP, Minitab, or equivalent.
- Excellent resource management and prioritization skills
- Executive-level written and verbal communication skills, with the ability to present validation strategy and risk to senior leadership, clients, and regulatory inspectors.
- Outstanding ability to analyze, interpret, and synthesize data; define problems; establish facts; draw valid conclusions; and make decisions.
- Excellent troubleshooting skills with the ability to resolve complex technical issues.
Work Environment/Physical Requirements- This position requires working regular business hours and, when needed, outside business hours (including evenings, weekends, and holidays).
- Ability to apply Good Manufacturing Practice (GMP) principles and knowledge of pharmaceutical processes, equipment, instrumentation, and procedures.
- Presence on the manufacturing floor with strict adherence to GMP cleanroom guidelines.
- Occasional travel to other Thermo Fisher sites or client locations may be required.
Compensation and BenefitsThe salary range estimated for this position based in Massachusetts is $103,100.00-$154,700.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
