Thermo Fisher Scientific Manager, Manufacturing Sciences & Technology in Cambridge, Massachusetts
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 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.
Recruit and develop direct reports in a fast-paced and technically complicated environment.
Oversee process validation and continued process verification and associated documentation in a heavily regulated environment.
Manage authoring and review of technical documentation including investigations and data analysis to support deviations and change controls.
Work cross-functionally with internal and external partners to drive program success.
Be a leader in environment, health & safety best practices.
How will you get here?
Education and experience
B.S. in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 6 years experience
M.S. or PhD in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field + 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
Skilled at clear technical communication to diverse internal and external stakeholders.
Strong organizational skills, proven people management, and demonstrated leadership in a fast-paced, technically complicated, cross-functional environment.
Expertise in biologics manufacturing including technical topics and working understanding of FDA, EMA and other regulatory bodies.
Highly developed troubleshooting and analysis skills with ability to lead others in solving complex, poorly defined technical issues using formal methods.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.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 .
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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