Principal Scientist Deviation Management Lilly Medicine Foundry

Role: Principal Scientist leading deviation and OOS investigations within Lilly's GMP Analytical Labs at the Medicine Foundry, supporting quality and compliance. Responsibilities: manage investigation lifecycle (protocols, root cause analysis, CAPA, change control), author reports, troubleshoot analytically, and serve as a quality champion on the ACE team. Collaborate cross-functionally with Manufacturing, QA, and Engineering to verify investigations and implement improvements. Requirements: BS in Chemistry, Biochemistry, Engineering, or related; 6+ years GMP lab or manufacturing experience, with expertise in deviation/OOS investigations, root cause analysis, and CAPA development; proven technical writing skills. HighValue: GMP analysis, deviation management, root cause analysis (5-Why, fishbone), CAPA, regulated environment, cGMP/data integrity, electronic QMS (TrackWise, Veeva), troubleshooting analytical/testing equipment. WorkSetup: Indianapolis/Lebanon, Indiana; travel 0-10%; first shift, with occasional off-hours support.