More jobs:
Lead, Drug Product & Process Development; Late-Stage CMC
Job in
Des Moines, Polk County, Iowa, 50319, USA
Listed on 2026-07-10
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-10
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing, Pharmaceutical Science/ Research
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. seeks an Associate Director, Drug Product & Process Development to provide technical and strategic leadership for late‑stage drug product programs, including process characterization and regulatory filings from Phase 2/3 through commercialization.
You will guide cross‑functional teams and ensure robust, scalable processes aligned with QbD. Responsibilities include overseeing scale‑up, tech transfer, PPQ, and post‑approval changes, and leading NDA/MAA filings
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