Associate Director, Drug Development

Job Summary

Providing technical and strategic leadership for late-stage drug product development programs, the full-time Associate Director, Drug Product & Process Development will manage process characterization, regulatory filings, and lifecycle management while working remotely.

Key Responsibilities

• Lead late-stage drug product development activities, including formulation optimization and process validation readiness
• Serve as the CMC drug product lead for NDA filings and support Health Authority interactions
• Oversee post-approval lifecycle management activities and drive continuous improvement initiatives

Required Qualifications

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+ years of relevant industry experience, or MS with 8+ years / BS with 10+ years of progressive experience
• Demonstrated experience in late-stage drug product development from Phase 3 to commercialization
• Direct involvement in NDA CMC submissions and regulatory agency interactions
• Proven expertise in drug product manufacturing processes, scale-up, and tech transfer
• Strong understanding of CMC regulatory requirements and global regulatory frameworks