Scientist III, Downstream, Manufacturing Sciences and Technology

Thermo Fisher Scientific • Plainville, MA

4d • Onsite

About The Position

The Scientist III in Manufacturing Sciences and Technology (MSAT), Downstream, provides technical leadership for complex viral vector and gene therapy manufacturing programs at Thermo Fisher Scientific’s Plainville, Massachusetts site, supporting Viral Vector Services. The role works at the intersection of process development and GMP manufacturing, leading technology transfer, new product introduction, process validation, manufacturing support, process optimization, and continuous improvement.

As the MSAT technical lead for assigned client programs, the Scientist III drives work from initial process assessment and facility fit evaluation through manufacturing implementation, process performance qualification (PPQ), and continued process verification (CPV). The role develops technical strategies, identifies and mitigates process risks, and ensures that manufacturing processes are scientifically sound, robust, reproducible, and compliant with applicable regulatory requirements.

The position serves as a downstream subject matter expert and functional technical lead across chromatography, filtration, and tangential flow filtration (TFF/UFDF). It supports transfer, scale-up, and troubleshooting of downstream processes for viral vector manufacturing, including AAV, lentiviral vectors, and other gene therapy modalities, and contributes to standardized practices and continuous improvement across downstream manufacturing operations.

The role is a primary technical contact for clients, leading technical discussions, presenting process and validation strategies, communicating risks and recommendations, and resolving complex technical challenges. It leads cross-functional technical activities with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, Validation, and Program Management to support program execution and manufacturing readiness.

The Scientist III leads MSAT technical work for process validation, including PPQ readiness, process risk assessments, control strategy development, protocol authoring and review, execution support, deviation assessment, and validation report preparation. The role also leads complex technical investigations, evaluates process performance and trends using statistical and analytical tools, and implements scientifically justified improvements. It requires technical independence, sound scientific judgment, and the ability to manage multiple complex programs and competing priorities. The position authors and reviews critical GMP documentation, mentors junior scientists, provides technical training and guidance, and collaborates with Thermo Fisher Scientific’s global network of technical experts while maintaining quality, regulatory compliance, and customer satisfaction.

Requirements

• Advanced degree plus a minimum of 3 years of relevant experience, or a bachelor’s degree plus a minimum of 5 years of relevant experience.
• Demonstrated professional experience in downstream biopharmaceutical manufacturing, process development, or MSAT, including chromatography, filtration, and/or TFF/UFDF.
• Strong technical expertise in process development, scale-up, and technology transfer, with demonstrated ability to lead technical activities for complex manufacturing programs.
• Experience with process validation, including PPQ preparation, execution, protocol/report development, and/or continued process verification.
• Expert knowledge of cGMP regulations, regulatory expectations, and pharmaceutical quality systems.
• Ability to lead complex technical investigations, perform root cause analysis, evaluate process risks, and implement effective corrective and preventive actions.
• Strong understanding of downstream process parameters, process performance, and manufacturing control strategies.
• Advanced project management, technical documentation, and organizational skills, including the ability to manage multiple programs and competing priorities.
• Strong analytical and statistical analysis capabilities, including proficiency with relevant statistical software and Microsoft Office applications.
• Excellent written and verbal communication skills, including the ability to lead technical discussions and present scientific information to clients and cross-functional teams.
• Ability to work independently and collaboratively in a dynamic, matrixed environment.
• Experience mentoring colleagues, providing technical guidance, and supporting technical training and knowledge transfer.
• Strong problem-solving skills, attention to detail, and commitment to continuous improvement.
• Ability to provide technical support to manufacturing operations as needed, including occasional weekend or off-hours coverage.
• Ability to travel up to 20% as required.

Nice To Haves

• Preferred fields of study include Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.
• Experience in viral vector or gene therapy manufacturing, including AAV or lentiviral vector processes, is strongly preferred.
• Additional language skills may be beneficial.

Responsibilities

• Lead assigned client programs as the MSAT technical lead, from process assessment and facility fit evaluation through manufacturing implementation, PPQ, and CPV.
• Develop and execute technical strategies; identify and mitigate process risks; and ensure processes are scientifically sound, robust, reproducible, and compliant with applicable regulatory requirements.
• Provide downstream technical leadership in chromatography, filtration, and TFF/UFDF.
• Support transfer, scale-up, and troubleshooting of downstream viral vector manufacturing processes, including AAV, lentiviral vectors, and other gene therapy modalities.
• Contribute to standardized practices and continuous improvement initiatives across downstream manufacturing operations.
• Serve as a primary technical point of contact for clients; lead technical discussions, present process and validation strategies, communicate risks and recommendations, and drive resolution of complex technical challenges.
• Lead cross-functional technical activities with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, Validation, and Program Management to support program execution and manufacturing readiness.
• Lead MSAT technical aspects of process validation, including PPQ readiness, risk assessments, control strategy development, protocol authoring and review, execution support, deviation assessment, and validation report preparation.
• Lead complex technical investigations, evaluate process performance and trends using statistical and analytical tools, and implement scientifically justified improvements.
• Author and review critical GMP documentation.
• Mentor junior scientists and provide technical training, guidance, and knowledge transfer.
• Provide technical support to manufacturing operations as needed, including occasional weekend or off-hours coverage.
• Travel up to 20% as required.

Benefits

• 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 of paid time off (PTO) and 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.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• May be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

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