About the role
Work Schedule First Shift (Days) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office Job Description About Thermo Fisher Scientific 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 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. Location / Division Specific Information This position is based at our Plainville, Massachusetts site, supporting Viral Vector Services (VVS). Our team supports the development, technology transfer, clinical manufacturing, process validation, and commercialization of viral vector-based gene therapies, helping clients advance innovative treatments for patients with serious and rare diseases. Description 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. 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 Education and Experience 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, 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. Experience in viral vector or gene therapy manufacturing, including AAV or lentiviral vector processes, strongly preferred. Knowledge, Skills, and Abilities 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 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, with 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. 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. Additional language skills may be beneficial for Compensation and Benefits The salary range estimated for this position based in Massachusetts is –. 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