Scientist III, Downstream, Manufacturing Sciences and Technology
Thermo Fisher Scientific
Summary
Join our team at Thermo Fisher Scientific as a Scientist III in Manufacturing Sciences and Technology (MSAT), Downstream, where you will provide technical leadership for complex viral vector and gene therapy manufacturing programs. Working at the intersection of process development and GMP manufacturing, you will lead technology transfer, new product introduction, process validation, and manufacturing support activities while driving process optimization and continuous improvement.
Job description
In this senior technical role, you will serve as the MSAT technical lead for assigned client programs, driving activities from initial process assessment and facility fit evaluation through manufacturing implementation, process performance qualification (PPQ), and continued process verification (CPV). You will develop and execute technical strategies, identify and mitigate process risks, and ensure manufacturing processes are scientifically sound, robust, reproducible, and compliant with applicable regulatory requirements.
As a downstream subject matter expert and functional technical lead, you will provide technical leadership across critical downstream unit operations, including chromatography, filtration, and tangential flow filtration (TFF/UFDF). You will support the transfer, scale-up and troubleshooting of downstream processes for viral vector manufacturing, including adeno-associated virus (AAV), lentiviral vectors, and other gene therapy modalities. You will also contribute to the development of standardized practices and continuous improvement initiatives across downstream manufacturing operations.
You will serve as a primary technical point of contact for clients, leading technical discussions, presenting process and validation strategies, communicating technical risks and recommendations, and driving the resolution of complex technical challenges. Working closely with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, Validation, and Program Management, you will lead cross-functional technical activities to ensure successful program execution and manufacturing readiness.
You will lead the MSAT technical aspects of process validation activities, including PPQ readiness, process risk assessments, control strategy development, protocol authoring and review, execution support, deviation assessment, and validation report preparation. You will also lead complex technical investigations, evaluate process performance and trends using statistical and analytical tools, and implement scientifically justified improvements that strengthen process robustness, quality, and manufacturing efficiency.
This position requires a high degree of technical independence, sound scientific judgment, and the ability to manage multiple complex programs and competing priorities. You will author and review critical GMP documentation, mentor junior scientists, provide technical training and guidance, and collaborate across Thermo Fisher Scientific's global network of technical experts while maintaining our high standards of quality, regulatory compliance, and customer satisfaction.
Requirements
- Advanced degree plus a minimum of 3 years of relevant experience, or bachelor's degree plus a minimum of 5 years of relevant experience
- Preferred fields of study: Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline
- 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
- Experience with process validation, including PPQ preparation, execution, protocol/report development, and/or continued process verification
- Experience in viral vector or gene therapy manufacturing, including AAV or lentiviral vector processes, strongly preferred
- Expert knowledge of cGMP regulations, regulatory expectations, and pharmaceutical quality systems
- Proven ability to lead complex technical investigations, perform 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
- Strong analytical and statistical analysis capabilities, including proficiency with relevant statistical software and Microsoft Office applications
- Excellent written and verbal communication skills
- Demonstrated 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
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- 401(k) Retirement Savings Plan
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.