Scientist III, Downstream, Manufacturing Sciences and Technology

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.

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