Director of Drug Product Development

Job Summary

Leading late-stage development and NDA enabling activities for oral solid dosage forms, the full-time Director of Drug Product Development will manage formulation, process development, scale-up, and regulatory deliverables while collaborating with cross-functional teams and external manufacturing partners in a remote environment.

Key Responsibilities

• Lead late-stage development of oral solid dosage forms, finalizing commercial formulations and manufacturing processes
• Execute drug product CMC activities for NDA submissions and ensure compliance with FDA and ICH standards
• Provide technical oversight of CDMOs and support technology transfer to commercial manufacturing sites

Required Qualifications

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline
• 10-12+ years of experience in oral solid dosage form drug product and process development
• Demonstrated experience supporting late-stage development and at least one NDA submission
• Strong expertise in OSD formulation and unit operations
• Proven ability to lead cross-functional project teams and manage timelines effectively