Mitesh Chauhan

Associate Director at Stealth BioTherapeutics

Role
Associate Director at Stealth Biotherapeutics
Location
Lowell, MA, US
LinkedIn followers
500 followers
Research & DevelopmentView LinkedIn profile

About Mitesh Chauhan

Experienced, Enthusiastic, collaborative and motivated leader in Pharmaceutical/ Biopharmaceutical industry with 11+ years of experience. Lead projects and team from early phase to commercialization. Expertise includes, Analytical method validation, Verification and transfers from CTL, CMO/to CMO and to Contract labs (CTO), cGMP and compliance auditor for Drug substance/Drug product. Regulatory author/review experience, IND, IMPD, NDA, ANDA, 505(b)2. Expertise in industry guidance such as ICH Q1, Q2, Q3, 210/211 Quality, c GMP, EU and FDA. laboratory instrumentation expertise HPLC, GC, USP-I, USP-II, UV, NIR, Raman, XRD, IR, USP/EP Wet Analysis.

Experience

  1. Associate Director

    Stealth Biotherapeutics

    Mar 2023 — Present

Education

  • Sardar Patel University

    B.pharm, Pharmacy

    2004 — 2008

  • Fairleigh Dickinson University-Florham Campus

    Master of Science, Pharmaceutical Chemistry

    2008 — 2010

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Mitesh Chauhan — Associate Director at Stealth Biotherapeutics in Lowell, MA, US | Unifers