Jason Wong
- Role
- Associate Director, Cmc Dossier Development, Global Research & Development at Sanofi
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Jason Wong
Biochemical engineer with over sixteen years of biopharmaceutical industry experience…
Experience
Associate Director, Cmc Dossier Development, Global Research & Development
Jan 2019 — Present
Provide expertise on all aspects (technical, scientific, and regulatory) of CMC product dossiers for Sanofi’s biologics research pipeline, develop solutions for explanations of scientific challenges, and lead teams to ensure timely submission of filings for global registrations throughout the value chain (first-in-human clinical studies to market authorization) consistent with current and evolving regulatory expectations. Partner with product development and regulatory teams to bring, interpret and address agency questions for successful regulatory submissions.
Skills
- Technology Transfer
- Purification
- Cell
- Gmp
- Cancer
- Protein Chemistry
- Cell Culture
- V&V
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