Manager, Manufacturing Sciences

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
*How will you make an impact?*
Serve as the front lines of technical management and execution for late stage clinical and commercial gene therapy manufacturing. From new product introduction through process performance qualification, manage a team responsible for all technical details of the manufacturing process. Success in this role means that patients will receive an entire new generation of lifesaving gene therapy medications.
*What will you do?*

* Enable team to provide on-the-floor technical and scientific support for critical manufacturing operations through schedule balancing and coaching.

* Facilitate design of experimental plans and studies across multiple disciplines and oversees the completion based on the defined deliverables.

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

* Oversee and define strategy for advanced data management and analysis.

* Lead teams in developing and owning control strategies and other technical documentation including protocols and reports.

*How will you get here?*
*Education and experience*

* B.S. 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.

* 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*

* 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 and grow project management skills in teams.

* Expert in biologics or vector manufacturing including technical topics in upstream and downstream.

* Extensive experience and leadership 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.

* Leader with proven ability to grow and retain teams. Emphasis on building consensus, driving performance, and owning decisions made by teams of diverse stakeholders.

* Experience with gowning and cleanroom behaviors within a GMP manufacturing space.

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.