Associate Director, Drug Product Development

Role: Associate Director, Pharmaceutical Development, leading formulation, process development, scale-up, technology transfer, and manufacturing for small molecule drug programs. Objectives include optimizing drug product development for clinical and commercial phases, ensuring regulatory compliance, and managing external partners. Responsibilities encompass directing formulation and process activities, interpreting manufacturing and analytical data, overseeing GMP manufacturing investigations, and collaborating with Quality, Supply Chain, and Regulatory teams to shape development and regulatory strategies. Qualifications: 10+ years in pharma/biotech with demonstrated expertise in drug product development, GMP manufacturing, and process validation; advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field; experience supporting clinical and commercial manufacturing preferred. Skills include strong analytical data interpretation, regulatory knowledge (FDA, EMA, ICH), CDMO management, and cross-functional communication. High-value specifics: experience with small molecules, both clinical and commercial stages, GMP compliance, and global regulatory interactions. Work setup involves some teleconferences outside standard hours, with up to 30% travel; salary range: $200,000-$215,000.