Kevin Hu
- Role
- Associate Director- Cmc at Atea Pharmaceuticals, Inc
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Kevin Hu
As an experienced drug substance SME with over 20 years of related industrial experience…
Experience
Associate Director- Cmc
Oct 2020 — Present
API (DS) lead for AT-752, a clinical candidate for anti-viral applications. Responsible for process R&D; delivery of API to meet clinical needs; providing supporting documents for regulatory filing. Managing external vendors for process research and development; providing scientific and technical guidance; developing a practical, free-to-operate, and ready to commercialize 2nd generation route. Managing external vendors for API production to meet clinical needs; working with other functions(QA/QC) to ensure delivery on time. Working on Late-Stage Process Development for AT-527, an oral anti-viral drug targeted for COVID-19; solved critical scale-up problems and developed 2nd generation route. Supervising CMO to prepare radiolabelled API for clinical studies; Managing external CMO to prepare all labelled compounds for clinical studies; Establishing CDA, MSA; drafting technical transfer package and RFP; drafting segments for filing. Responsible fro evaluating process safety for all productions at CMOs.
Education
Donghua University
BS, Chemical Engineering
Florida State University
Postdoc, Process Chemistry Robert Holton's Group
1998 — 2001
Brigham Young University
Ph.D., Organic Chemistry
1992 — 1998
Skills
- Organic Chemistry
- Gas Chromatography
- Gc
- Technology Transfer
- Cdmo Management
- Process Chemistry
- Medicinal Chemistry
- Lead Change
- Biotechnology
- Process Validation
- Gmp
- Chemistry
- Lc-Ms
- Clinical Development
- CRO
- Hplc
- Cmc
- Nmr
- Organic Synthesis
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