Associate Director, CMC, Drug Product

Role: Associate Director, CMC, Drug Product, overseeing early-stage formulation and manufacturing development of small molecule drug candidates for Phase 1 and 2 clinical programs. Responsibilities: lead formulation development, manage external CDMOs, coordinate clinical trial material manufacturing, author regulatory CMC submissions, and ensure compliance with cGMP standards. Collaborate with discovery and development teams, provide input on stability and packaging, and stay informed on industry science and regulations. Qualifications: PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 10+ years in pharma/biotech; experience in small molecule drug product development, including powders, capsules, tablets, and suspensions; proven CDMO management and regulatory documentation skills. High-Value: focus on small molecule drug development, early-phase clinical manufacturing, global regulatory submissions (IND, NDA), cGMP compliance, and cross-functional collaboration. Work setup: hybrid in Needham, MA, with potential international travel.