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Senior Drug Product & Process Development Director

Job in Carson City, Douglas County, Nevada, 89702, USA
Listing for: Otsuka America Pharmaceutical Inc.
Full Time position
Listed on 2026-08-17
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Pharmaceutical Manufacturing
  • Management
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 169222 - 253000 USD Yearly USD 169222.00 253000.00 YEAR
Job Description & How to Apply Below

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Drug Product & Process Development to lead late-stage drug product development from Phase 2/3 through commercialization, driving formulation optimization, process validation readiness, and robustness studies.

The role serves as a CMC leader for NDA filings, supports FDA/EMA interactions, and guides post-approval lifecycle management, including change control, tech transfer, and site transfers.

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Position Requirements
10+ Years work experience
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