Principal Scientist GMP Microbiology Lilly Medicine Foundry

Role: Principal Scientist, GMP QC Microbiology at Lilly supports microbiological testing and batch disposition for clinical GMP manufacturing at the Lilly Medicine Foundry. Responsibilities: perform and oversee sterility, bioburden, endotoxin, microbial limits, and water testing; lead method validation, transfers, and investigations; author change controls and SOPs; support regulatory compliance and audit readiness; mentor junior analysts; contribute to continuous improvement and safety in a GMP environment. Requirements: BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, with 3+ to 5+ years of cGMP microbiology experience; proficiency in microbiological tests, investigations, and regulatory standards; experience with sterile drug operations preferred. HighValue: GMP microbiology, clinical-stage (preclinical or Phase 1/2), microbiological testing, method validation, investigations, regulatory audits, sterile manufacturing, data systems (MODA, LabVantage, TrackWise), microbial identification techniques, greenfield lab experience. WorkSetup: initial location in Carmel, IN, with occasional work in Indianapolis; permanent in Lebanon, IN; <5% travel; controlled cleanroom environment; may require off-hours support.