Associate Director, Drug Product CMC

Role: Associate Director of Drug Product in Lilly's CMC group, supporting early-stage development of small molecule neurotherapeutics targeting sleep-wake disorders, including narcolepsy and hypersomnia. Responsibilities: oversee nonclinical formulation development, manage CROs and CDMOs, guide physiochemical characterization, design formulations (oral, subcutaneous, IV), and support clinical formulation projects; collaborate across discovery, nonclinical, clinical, and regulatory teams; prepare regulatory documentation for IND submissions. Requirements: BS/MS in Pharmaceutical Sciences or related; 7+ years in small molecule formulation development, with experience supporting Phase I-III programs, expertise in poorly soluble compounds, and proficiency with analytical techniques (HPLC, XRPD, DSC, TGA, DVS). Preferred: PhD, strong project management, strategic problem-solving skills, and experience managing external vendors. High-Value: small molecule, early-phase clinical development, nonclinical and clinical formulation, cGMP knowledge, cross-functional collaboration. Work setup: US-based role with domestic and international travel (~5-10%).