Job Description
The Associate Director, Drug Product & ProcessDevelopment,will provide technical and strategic leadership forlate‑stagedrug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), andpost‑approvallifecycle management (LCM). This role will serve as a key CMC contributor tocross‑functionalprogram teams, ensuring robust, scalable, andregulatory‑compliantdrug product processes from Phase 2/3 through commercialization and beyond.
Key Responsibilities
Drug Product & Process Development
Leadlate‑stagedrug product development activities(Phase 2/3 through commercial launch), including formulation optimization, process validation readiness, and robustness studies.
Provide technical oversight fordrug product manufacturing processes, includingscale‑up, tech transfer, PPQ, and commercial manufacturing support.
Ensure developm...
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Submit ApplicationJob Details
- Location United States, United States
- Job Type Full time
- Category Operations Specialties Managers
- Posted Date July 04, 2026
- Application Deadline August 13, 2026