Associate Director, Late-Stage Drug Product & Process

Otsuka Pharmaceutical Companies (U.S.); United States; Sur place; USD 169 000 - 253 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

401(k) match

Paid holidays & leave

Résumé du poste

Otsuka Pharmaceutical Companies (U.S.) is seeking an Associate Director of Drug Product & Process Development to provide technical and strategic leadership for late-stage drug product development programs, overseeing formulation optimization, process validation readiness, and robust, scalable manufacturing processes from Phase 2/3 through commercialization and beyond.

The role leads CMC regulatory filings, collaborates with Regulatory Authorities, and drives lifecycle management, post‑approval

Qualifications

• PhD with 5+ years of industry experience or MS/BS with extensive experience in drug product/process development
• Experience in late-stage drug product development (Phase 3 to commercial)
• Direct involvement in NDA/CMC submissions and regulatory agency interactions
• Strong knowledge of CMC regulatory requirements and global frameworks
• Hands-on experience with lifecycle management, change control, and post-approval changes

Responsabilités

• Lead late-stage drug product development activities from Phase 2/3 to commercial launch
• Oversee scale-up, tech transfer, PPQ, and validation
• Align development strategy with QbD principles and control strategies
• Prepare and review development plans, process descriptions, reports, and validation summaries
• Serve as CMC lead for NDA filings and regulatory interactions

Connaissances

Late-stage development

CMC regulatory

Cross-functional leadership

Technical writing

Scale-up & tech transfer

Formation

PhD in Pharmaceutics

MS in related field

Description du poste

Otsuka Pharmaceutical Companies (U.S.) is seeking an Associate Director of Drug Product & Process Development to provide technical and strategic leadership for late-stage drug product development programs, overseeing formulation optimization, process validation readiness, and robust, scalable manufacturing processes from Phase 2/3 through commercialization and beyond.

The role leads CMC regulatory filings, collaborates with Regulatory Authorities, and drives lifecycle management, post‑approval