MSAT Scientist II, Drug Product

Thermo Fisher Scientific • Plainville, MA

1d • Onsite

About The Position

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 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 - 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. 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. 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.

Requirements

• 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.
• Experience authoring or reviewing GMP documentation, including protocols, reports, deviations, change controls, risk assessments, and technical assessments.
• 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.

Nice To Haves

• Preferred Fields of Study: Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Molecular Biology, or related scientific field.
• 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

Responsibilities

• Provide scientific and technical support for drug-product manufacturing operations
• Lead or support technology transfers of drug-product processes for clinical and commercial programs.
• Develop process-validation strategies and author or review process-performance qualification protocols, reports, and support documentation.
• Lead or support complex deviation investigations, nonconformance investigations, product-impact assessments, and root-cause analyses.
• Develop and maintain process-monitoring and continued process verification programs.

Benefits

• competitive remuneration
• annual incentive plan bonus scheme
• healthcare
• 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
• short- and long-term disability
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level