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Senior Drug Product & Process Development Lead; Late-Stage

Job in Saint Paul, Ramsey County, Minnesota, 55199, USA
Listing for: Otsuka America Pharmaceutical Inc.
Full Time position
Listed on 2026-07-28
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Pharmaceutical Manufacturing, Pharmaceutical Science/ Research, Pharma Engineer
Salary/Wage Range or Industry Benchmark: 169222 - 253000 USD Yearly USD 169222.00 253000.00 YEAR
Job Description & How to Apply Below
Position: Senior Drug Product & Process Development Lead (Late-Stage)

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Drug Product & Process Development to lead late-stage drug product development from Phase 2/3 through commercialization and beyond, ensuring robust, scalable, regulatory-compliant processes.

The role shapes development from formulation optimization to process validation readiness. The ideal candidate will drive CMC strategy for NDA/MAA filings, oversee scale-up, tech transfer, and post-approval lifecycle management, and

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Position Requirements
10+ Years work experience
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