Scientist III, Downstream, Manufacturing Sciences and Technology

Thermo Fisher Scientific • Plainville, MA

6d • 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 operates 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 MSAT technical lead for assigned client programs, the Scientist III drives activities 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 helps ensure processes are scientifically sound, robust, reproducible, and compliant with applicable regulatory requirements.

As a downstream subject matter expert and functional technical lead, the role supports chromatography, filtration, and tangential flow filtration (TFF/UFDF), including transfer, scale-up, and troubleshooting of processes for AAV, lentiviral vectors, and other gene therapy modalities. The Scientist III also serves as a primary technical client contact, leads cross-functional technical activities, and collaborates with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, Validation, and Program Management.

The position leads MSAT technical aspects of process validation, including PPQ readiness, process risk assessments, control strategy development, protocol authoring and review, execution support, deviation assessment, and validation report preparation. It also leads complex technical investigations, evaluates performance and trends using statistical and analytical tools, authors and reviews critical GMP documentation, mentors and trains junior colleagues, and collaborates with technical experts across the company’s global network. The role requires technical independence, sound scientific judgment, and management of multiple complex programs and competing priorities.

Requirements

• Advanced degree and at least 3 years of relevant experience, or a bachelor’s degree and at least 5 years of relevant experience.
• Relevant experience in downstream biopharmaceutical manufacturing, process development, or MSAT, including chromatography, filtration, and/or TFF/UFDF.
• Technical expertise in process development, scale-up, and technology transfer, with ability to lead technical activities for complex manufacturing programs.
• Experience with process validation, including PPQ preparation, execution, protocol or report development, and/or continued process verification.
• Expert knowledge of cGMP regulations, regulatory expectations, and pharmaceutical quality systems.
• Ability to lead complex technical investigations, conduct root cause analysis, evaluate process risks, and implement 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 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 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 manufacturing technical support, including occasional weekend or off-hours coverage.
• Ability to travel up to 20% as required.

Nice To Haves

• Experience in viral vector or gene therapy manufacturing, including AAV or lentiviral vector processes, is strongly preferred.
• A degree in Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline is preferred.
• Additional language skills may be beneficial; no specific language is stated.

Responsibilities

• Provide technical leadership for complex viral vector and gene therapy manufacturing programs.
• Serve as MSAT technical lead for assigned client programs, from initial process assessment and facility fit evaluation through manufacturing implementation, PPQ, and CPV.
• Develop technical strategies, identify and mitigate process risks, and support robust, reproducible, scientifically sound, and compliant manufacturing processes.
• Lead downstream technical activities involving chromatography, filtration, and TFF/UFDF.
• Support technology transfer, scale-up, and troubleshooting of downstream viral vector processes, including AAV and lentiviral vector processes.
• 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 technical challenges.
• Lead cross-functional technical activities with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, Validation, and Program Management.
• Lead MSAT technical aspects of process validation, including PPQ readiness, process risk assessments, control strategy development, protocol authoring and review, execution support, deviation assessment, and validation report preparation.
• Lead complex technical investigations, perform root cause analysis, assess process performance and trends, 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, including 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