Director, Drug Product Development – NDA‑ OSD
Job in
Frankfort, Franklin County, Kentucky, 40601, 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, Pharma Engineer
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. seeks a Director of Drug Product Development to lead late-stage development and NDA‑enabling activities for oral solid dosage forms. You will drive formulation, process development, scale‑up, validation, and regulatory deliverables to support NDA submission and commercial launch.
You will act as the Drug Product CMC lead, collaborating with cross-functional teams and external CDMOs to ensure robust, compliant products and inspection readiness across programs.
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