Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry

Role: Principal Scientist, GMP Environmental Monitoring (EM) at Lilly's new Medicine Foundry, focusing on cleanroom EM and utility monitoring programs supporting GMP manufacturing. Responsibilities: own and develop the site's EM program, oversee daily operations in classified areas, support contamination control, and maintain inspection readiness; lead investigations into environmental excursions; review and approve data; ensure instrument qualification and calibration; train and mentor EM staff; collaborate with Manufacturing, QC, Facilities, and QA; and support qualification and validation activities for GMP compliance. Requirements: BS or MS in Microbiology, Biology, or related; 5+ years GMP microbiology or EM experience, including regulatory interactions; authorized to work in the U.S. without sponsorship. Preferred skills: aseptic manufacturing experience, proficiency with EM data systems (MODA, LabVantage), hands-on knowledge of sampling instruments, microbial identification techniques, and experience in greenfield GMP environments. HighValue: GMP microbiology, environmental monitoring, cleanroom qualification, contamination control, sterile operations, data integrity, inspection readiness, and training in a pioneering facility. WorkSetup: permanent in Lebanon, IN, with occasional work in Indianapolis; <5% travel; controlled cleanroom environment. Physical activities include gowning, standing, and walking in GMP settings.