Director, Quality Analytical Technical Lead, Small Molecule

Role: The Analytical Technical Lead (ATL) at Director level is the global owner for analytical lifecycle management of assigned commercial small molecule products across major markets, supporting post-approval maintenance and expansion. Responsibilities: serve as the primary technical contact, oversee analytical strategies for drug substance, drug product, and raw materials; lead investigations into OOS/OOT, deviations, and method performance; ensure analytical control strategies align with product risk profiles; manage regulatory submissions and post-approval changes; govern external QC networks and support audits and inspections; influence lab capacity and capability planning. Qualifications: Bachelor's degree with 10+ years, Master's with 7+ years, or Doctorate with 5+ years in biopharmaceuticals, with extensive GMP QC and analytical sciences experience. Skills include expertise in small molecule methods (HPLC, UPLC, GC), validation, stability, and data integrity, along with strong stakeholder management and technical writing. High-value specifics: focus on small molecule lifecycle management, global regulatory support, GMP compliance, and analytical method lifecycle ownership. Work setup involves up to 20% travel; location specifics not detailed.