Staff Scientist – Process Validation & Technology Transfer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Standing for full shift

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Thermo Fisher Scientific – large molecule is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking experienced individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.

This 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 Transfer

Location: 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 & Experience

B.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