Principal Scientist GMP Microbiology Lilly Medicine Foundry

Role: Principal Scientist supporting GMP microbiology testing at Lilly's Medicine Foundry, focusing on analytical quality and compliance for clinical manufacturing. Responsibilities: execute and oversee microbiological assays (sterility, bioburden, endotoxin, water testing), lead method validation and change controls, investigate OOS/OOT issues, author and maintain GMP documentation, support audit readiness, and mentor junior analysts. Requirements: BS or MS in Microbiology, Biology, Biochemistry, or related field; 5+ years (BS) or 3+ years (MS) in cGMP pharmaceutical microbiology, including compendial methods and investigations; experience with sterile manufacturing (fill-finish, lyophilization), data systems (MODA, LabVantage, TrackWise, Veeva), and microbial identification (MALDI-TOF, Vitek). Preferred: experience in startup labs, RMM platforms, LIMS, ELN; knowledge of microbiology in biologics or sterile drug products. HighValue: GMP microbiology, clinical-stage biologics, method validation, regulatory compliance, inspection readiness, laboratory build-out, training, and mentorship. WorkSetup: on-site at Carmel and Lebanon, IN; less than 5% travel; controlled cleanroom environment; occasional off-hours support.