Manager, Manufacturing Science and Technology

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
Viral Vector Services team located in Cambridge, MA
How will you make an impact?
The MST Manager is a professional in technical management and execution for late stage clinical and commercial gene therapy manufacturing. From new product introduction through process performance qualification, MST Managers lead a team responsible for all technical details of the manufacturing process. Success in this role means that patients will receive an entire new generation lifesaving gene therapy medications.
What will you do?
• Provide technical leadership to process engineers, scientists, and associates for late stage clinical, process validation and commercial stage gene therapy products.
• Grow and direct a team of 4-6 process engineers in a fast-paced and technically exciting environment.
• Coordinate process validation and continued process verification and associated documentation in a heavily regulated environment.
• Guide technical documentation including tech transfer, investigations, and data analysis to support deviations and change controls.
• Collaborate with partners to drive program success.
• Be an authority in environment, health & safety.
How will you get here?
Collaborative leadership in a fast-paced and highly technical environment. Driving performance to meet ambitious first-to-market clinical/commercialization timelines while developing team knowledge and abilities to adapt to challenges of maturing program.
Education and experience
• B.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field is required + 6 years experience
• M.S. or PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field is preferred + 4 years experience
• Experience to include 4+ years directly in FDA and EMA regulated manufacturing. Experience in manufacturing operations, engineering, MST roles is highly valued.
Knowledge, Skills, Abilities
• Clear technical communication to diverse internal and external partners.
• Strong organizational skills, proven people management and leadership in a fast-paced, technically sophisticated, collaborative environments.
• Expertise in biologics manufacturing and/or virology including technical topics and working understanding of FDA, EMA regulations.
• Highly developed troubleshooting and analysis skills with ability to lead teams in solving complex technical issues.
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 www.thermofisher.com.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.