Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job DescriptionTitle: MSAT Scientist II, Drug ProductLocation/Division Specific InformationThermo Fisher Scientific - Viral Vector Services (VVS) is a multifaceted gene therapy contract development and manufacturing organization (CDMO) that seeks sharp 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.
Pharma Services |Viral Vectors | 5 Commerce Drive, Plainville, MA |100% Onsite Days Discover Impactful Work: The Drug Product Scientist, Manufacturing Science and Technology (MSAT), provides advanced scientific and technical leadership for commercial and clinical drug-product manufacturing processes. This role serves as a subject-matter expert for formulation, compounding, filtration, filling, visual inspection, and associated manufacturing operations.
A Day in The Life: - The Scientist II is responsible for technology transfer, process validation, continued process verification, manufacturing investigations, and lifecycle management.
- The role works cross-functionally with Manufacturing, Process Development, Quality, Engineering, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure processes are scientifically sound, compliant, robust, and capable of consistently delivering products that meets established quality requirements.
Responsibilities:- Drug-Product Process Support: Provide scientific and technical support for drug-product manufacturing operations
- Technology Transfer and Process Introduction: Lead or support technology transfers of drug-product processes for clinical and commercial programs.
- Process Validation: Develop process-validation strategies and author or review process-performance qualification protocols, reports, and support documentation.
- Investigations and Technical Problem-Solving: Lead or support complex deviation investigations, nonconformance investigations, product-impact assessments, and root-cause analyses.
- Process Monitoring and Lifecycle Management: Develop and maintain process-monitoring and continued process verification programs.
Keys to Success: Education/Experience- Advanced Degree with no prior experience required, OR Bachelor's Degree plus 2 years of experience in GMP manufacturing, process development, or related technical role required.
- Preferred Fields of Study: Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Molecular Biology, or related scientific field.
- Experience authoring or reviewing GMP documentation, including protocols, reports, deviations, change controls, risk assessments, and technical assessments.
- Experience authoring or reviewing GMP documentation, including protocols, reports, deviations, change controls, risk assessments, and technical assessments.
- Demonstrated experience with one or more of the following:
- Formulation and compounding
- Sterile filtration
- Aseptic filling
- Visual inspection
- Container-closure systems
- Single-use manufacturing systems
- Process characterization and validation
Knowledge, Skills and Abilities- Strong data-analysis and technical-writing capabilities.
- Ability to manage multiple priorities and operate effectively in a fast-paced, matrixed manufacturing environment.
- Significant experience supporting drug-product process development, manufacturing, technology transfer, validation, or commercial lifecycle management.
- Strong understanding of pharmaceutical manufacturing principles and current Good Manufacturing Practices.
Work Environment/Physical Requirements (adjust as required)- Standard office environment with some interaction in GMP manufacturing and laboratory settings.
- May require occasional standing, walking, and use of PPE during client visits or facility tours.
- This role is based 100% onsite at the Plainville, MA facility.
BenefitsWe offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Compensation and BenefitsThe salary range estimated for this position based in Massachusetts is $66,000.00-$99,000.00.
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
