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
Cambridge, MA

How will you make an impact?
The Process Engineer II is a leader of technical support and execution for late stage clinical and commercial gene therapy manufacturing. From new product introduction through process performance qualification, process engineers are responsible for keeping technical deliverables on track and driving process improvements. Success in this role means that patients will receive an entire new generation lifesaving gene therapy medications.

What will you do?
2022 Provide on-the-floor technical and scientific support for critical manufacturing operations
2022 Support for complex process/product impacting investigations
2022 Oversee data management and analysis
2022 Subject matter expert for tech transfers and validation readiness
2022 Own control strategies and other technical documentation including protocols and reports
2022 Identify and drive continuous improvement projects

Technical expertise in a fast-paced and highly technical environment at the cutting edge of gene therapy manufacturing. Driving projects to meet aggressive first-to-market clinical/commercialization timelines while defining standards and driving improvements.

How will you get here?
Education
2022 B.S. (required) in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 4 years experience
2022 M.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 2 years experience
2022 PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field

Experience
2022 Experience expected to include 2+ years directly in FDA and EMA regulated manufacturing.
2022 Experience in manufacturing operations, engineering, MST roles is highly valued.

Experience in lab or commercial scale cell culture and transfection techniques

Knowledge, Skills, Abilities
2022 Expert in clear technical communication to diverse internal and external stakeholders
2022 Strong project management skills with proven ability to deliver technical projects
2022 Expert in biologics manufacturing
2022 Experience with FDA and EMA oversight
2022 Ability to troubleshoot complex technical issues and perform advanced data analysis
2022 Team player with proven ability to build consensus with 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 www.thermofisher.com.