Associate Director, Stability Management

Role: Associate Director of Stability Management within Exelixis' CMC department, overseeing stability and reference standard programs for drug substance, drug product, and reference standards for both clinical and commercial projects. Responsibilities include establishing stability policies, managing stability studies according to ICH guidelines, authoring protocols and reports, overseeing CMO testing, analyzing stability data, investigating deviations, and leading stability review meetings. Supervises stability staff, providing direction and performance management. Requirements: BS/BA with 11+ years, MS/MA with 9+ years, or PhD with 5+ years in a related field; GMP experience preferred. Skills: strong technical, analytical, and scientific expertise in small molecules and solid oral dosage forms; experience with stability testing, data trending, and regulatory documentation. HighValue: stability management, GMP, ICH guidelines, small molecules, solid oral dosage, clinical and commercial stability, team leadership, 10% travel. Work setup: primarily office-based environment.