Senior Director, Drug Product CMC

Role: Senior Director of Drug Product within the CMC group, leading nonclinical and clinical formulation development for small molecule drug candidates supporting Phase I-III studies. Responsibilities: manage external CROs/CDMOs for physiochemical characterization, pre-formulation, stability, and formulation of oral, subcutaneous, and intravenous drugs; oversee protocol and report review; provide CMC input at cross-functional meetings; coordinate shipments and support regulatory documentation for IND/CTA submissions. Requirements: Ph.D. in Chemistry, Pharmaceutical Sciences, or related field; 10+ years in drug product/formulation development, with expertise in poorly soluble compounds, dosage forms, and cGMP compliance; proficiency in analytical techniques like HPLC, XRPD, DSC; experience managing external partners and leading multiple programs. High-Value: small molecules, Phase I-III, nonclinical/clinical formulation, cGMP, regulatory support, global vendor management. WorkSetup: US-based, with domestic and international travel; full-time, exempt.