Parin Shah
MS&T | CMO/CDMO Management | Product Development, Scale-up & LCM | Technology Transfer & Process Optimization | Team Leadership & Development | End-to-End Product Development
- Role
- Associate Director, Process Development (Msat) at Harmony Biosciences
- Location
- Dayton, NJ, US
- LinkedIn followers
- 500 followers
About Parin Shah
As a pharmaceutical R&D executive with over a decade of experience, I specialize in…
Experience
Associate Director, Process Development (Msat)
Jan 2026 — Present · NJ, US
Lead technology transfer, scale-up, and process validation activities for late-stage pharmaceutical development programs.• Provide technical and operational oversight of multiple CDMOs to ensure reliable clinical and commercial drug product supply.• Manage clinical drug product manufacturing and packaging while supporting cross-functional teams across Regulatory, Quality, Supply Chain, and Clinical.• Serve as SME for manufacturing processes, troubleshooting issues, and supporting regulatory submissions (INDs, NDAs, IMPDs).• Drive process robustness and continuous improvement through data analysis, validation studies, and on-site support at manufacturing partners.
Education
Sharda Mandir VInay Mandir
12th Grade
1995 — 2002
Long Island University
Master of science in Industrial Pharmacy
2007 — 2010
Gujarat University
Bachelor of Pharmacy
2002 — 2006
Rutgers University-New Brunswick
Doctor of Philosophy (Ph.D.)
2015 — 2020
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