Staff Scientist – Process Validation & Technology Transfer

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 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.

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.

• 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 Q8Q11 EU GMP Annex 1 and applicable cell and gene therapy guidance.
• Expertise in lifecycle process validation (Stage 13) 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.

• 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 Benefits

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: Experience:

Staff IC