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

  1. Associate Director, Process Development (Msat)

    Harmony Biosciences

    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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Parin Shah — Associate Director, Process Development (Msat) at Harmony Biosciences in Dayton, NJ, US | Unifers