Director, Drug Product

Role: Lead drug product development and manufacturing strategy for small molecule programs in a remote setting. Primary objectives include overseeing formulation and process development, technology transfer, process validation, and lifecycle management from early clinical stages through commercialization. Responsibilities encompass managing external CDMOs, ensuring compliance with GMP, developing robust control strategies, authoring regulatory documentation, and supporting clinical supply planning. The role requires close collaboration with CMC, Analytical, Quality, Regulatory, and Clinical teams to ensure product quality, scalability, and regulatory alignment. Qualifications: Master’s or higher in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field with 10+ years in pharmaceutical or biotech industry; extensive experience in formulation and process development, scale-up, validation, and GMP manufacturing support; proven success managing external partners and regulatory submissions. High-Value: Small molecule therapeutic area, drug development from early clinical to commercialization, cGMP compliance, global regulatory frameworks (FDA, EMA, ICH), technical oversight of outsourced manufacturing, and expertise in analytical testing, stability, and control strategies. Work setup: fully remote, reporting to SVP, CMC and Supply Chain.