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Thermo Fisher Scientific Process Engineer III, MST Drug Product in Cambridge, Massachusetts

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:

Cambridge, MA

How will you make an impact?

The Process Engineer III 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.

Participates in cross functional technology transfer teams for ENG /cGMP Drug product (or Fill finish) manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer.

What will you do?

  • Provide on-the-floor technical and scientific support for critical manufacturing operations.

  • Designs and executes experimental plans and studies within discipline based on the defined deliverables.

  • Expertise and ownership of complex process/product impacting investigations.

  • Oversee strategy for data management and analysis.

  • Technical lead for tech transfers and validation readiness.

  • Own control strategies and other technical documentation including protocols and reports.

  • Identify and drive large and complex continuous improvement projects.

How will you get here?

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.

Education and Experience

  • B.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 5 years experience

  • M.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 2 years experience

  • PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 1 year experience.

  • Experience in manufacturing operations, engineering, MST roles is highly valued.

Knowledge, Skills, Abilities

  • Expert in clear technical communication to diverse internal and external stakeholders.

  • Highly developed project management skills including proven ability to deliver large technical projects on aggressive timelines

  • Expert in biologics manufacturing or virology including technical topics in Aseptic Manufacturing and Sterile Fill-Finish

  • Direct experience in cGMP, FDA, EMA oversight including quality records and audits.

  • Proven ability to troubleshoot complex technical issues and perform advanced data analysis in a cross-functional team

  • Team player with proven ability to build consensus and drive performance with diverse stakeholders

  • Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing

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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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