MS&T Drug Product Manager (Viral Vector Services)

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Job description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Location/Division Specific Information

Supporting the Viral Vector Services team in Plainville, MA

How will you make an impact?

The Drug Product MS&T manager will lead a team of engineers responsible for tech transfer, process validation, and manufacturing support of clinical and commercial programs.

What will you do:

• Enable team to provide on-the-floor technical and scientific support for critical manufacturing operations through schedule balancing and coaching.
• Own complex process/product impacting investigations.
• Facilitate design of experimental plans and studies across multiple disciplines and oversee the completion based on the defined deliverables.
• Oversee and drive strategy for advanced data management and analysis.
• Technical lead and owner for tech transfers and validation readiness across multiple products.
• Own control strategies and author technical documentation including protocols and reports.
• Identify and drive large and complex continuous improvement projects.

Education and experience:

• B.S. required in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 8 years experience.
• M.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 6 years experience.
• PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 3 years experience.
• Exceptional talent for clear technical communication to diverse internal and external stakeholders to drive decision making.
• Highly developed project management skills including proven ability to lead large matrix teams to deliver projects.
• Expert in viral vector or biologics manufacturing including advanced technical topics in drug product.
• Extensive experience in FDA, EMA oversight including investigations, CAPA, and audits.
• Proven ability to troubleshoot complex technical issues and lead cross-functional teams in analysis and decision making.
• Team player with proven ability to build consensus, drive performance, and own decisions made by teams of diverse stakeholders.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .