Sr. Principal Scientist, Oral Drug Product Development

Role: Senior scientific leader responsible for strategic and technical oversight of small molecule oral drug product development from early to late stages. Responsibilities: lead formulation design, process development, manufacturability assessments, technology transfer, and clinical manufacturing; develop innovative formulation solutions for challenging compounds; serve as the senior cross-functional CMC representative influencing development, regulatory submissions, and portfolio decisions; oversee external partnerships and adopt new development technologies; mentor scientific teams. Requirements: PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field; 12+ years in oral drug development; proven track record in formulation, process scale-up, technology transfer, and regulatory documentation; experience with oral solid dosage forms, including poorly soluble or permeable compounds; knowledge of CMC, phase-appropriate strategies, and external manufacturing. Preferred: expertise in enabling technologies (e.g., amorphous dispersions, hot-melt extrusion), late-stage development, NDA/MAA support, manufacturing operations, digital tools, and external CMO management. HighValue: focus on small molecules, challenging formulations, early to late-stage development, regulatory engagement, and external partnerships. WorkSetup: unspecified; global leadership role.