Director of Drug Product Development

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