Senior Director, Analytical Development CMC

Role: Senior Director of Analytical Development within Lilly's CMC group, focused on small molecule drug substance and oral solid dose formulations for neurological conditions. Objectives include leading analytical strategy, method development, validation, and characterization across multiple development stages, especially pre-IND through registration. Responsibilities encompass managing external CDMOs, ensuring compliance with cGMP/regulatory standards, reviewing validation and stability data, and supporting regulatory filings. Requirements: PhD in chemistry or pharmaceutical sciences; 10+ years in small molecule pharma, with deep expertise in analytical development, GMP validation, stability programs, and regulatory guidance. Preferred skills include experience managing outsourced analytical activities, leadership in CMC teams, and a strong technical background in physical/chemical characterization. High-value specifics include focus on small molecules, oral solid dosage forms, and early to late-stage development (preclinical to registration). The role involves cross-functional collaboration with Quality and Regulatory teams, and occasional domestic and international travel. Work location is in the US.