Principal Scientist Deviation Management Lilly Medicine Foundry

Role: Principal Scientist in Deviation Management at Lilly's GMP Analytical Labs supporting the Lilly Medicine Foundry, focusing on investigation leadership and quality compliance. Responsibilities: lead deviations and OOS investigations using root cause analysis; author and review investigative reports, CAPA plans, and change controls; troubleshoot hands-on to distinguish true deviations; serve as a quality champion on the ACE team; analyze investigation trends and mentor junior staff. Requirements: BS in Chemistry, Biochemistry, Engineering, or related; 6+ years GMP manufacturing/quality experience or MS with 3+ years; expertise in deviation/OOS investigations, root cause analysis, regulatory compliance, and technical report writing. HighValue: GMP, GxP, deviation & CAPA management, root cause analysis (5-Why, fishbone, fault tree), regulated environment, involvement in inspections, and familiarity with electronic quality systems (TrackWise, Veeva). WorkSetup: initial in Indianapolis, permanent at Lilly Medicine Foundry in Lebanon, Indiana; travel 0–10%; first shift with occasional off-hours support.