Associate Director, Regulatory Starting Material

Role: Associate Director, Regulatory Starting Material at Centessa (Lilly subsidiary), leading strategy and justification of RSM selection for drug substance manufacturing supporting late-stage clinical and commercial programs. Responsibilities: define and defend synthetic routes, manage supply and scale-up, author regulatory submissions, lead health authority interactions, evaluate manufacturing processes with Process Chemistry and Analytical teams, oversee technology transfer and process changes, manage CMO relationships, monitor regulatory guidance, support due diligence, and mentor a team. Qualifications: PhD in chemistry or chemical engineering, 7+ years in CMC, process chemistry, or drug substance development, with proven experience in late-stage clinical or commercial programs, supporting regulatory strategy for RSM and manufacturing, including authoring submissions and managing external partners. High-Value: focus on drug substance, late-stage clinical or commercial phases, CMC regulatory strategy, process chemistry expertise, global regulatory guidance, and cross-functional collaboration. WorkSetup: US-based with occasional travel (~10-20%).