Late-Stage Drug Product & Process Development Lead
Job in
Charleston, Kanawha County, West Virginia, 25329, 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
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. seeks Associate Director, Drug Product & Process Development to lead late-stage development from Phase 2/3 through commercialization.
You will drive formulation optimization, process validation readiness, and robust, regulatory-compliant drug product processes. The role requires deep CMC expertise, cross-functional leadership, and strategic oversight of NDA/MAA filings and post-approval lifecycle management, with a focus on QbD and scalable manufacturing
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