Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry

Role: Principal Scientist, GMP Environmental Monitoring (EM) at Lilly's Medicine Foundry supporting GMP manufacturing operations. Responsibilities: serve as technical SME for cleanroom EM and utility monitoring, oversee daily operations, develop sampling strategies, support qualification and validation activities, review data for compliance and audit readiness, lead investigations of excursions, and mentor EM staff. Collaborate with Manufacturing, QC, Facilities, and QA to ensure inspection readiness and build a quality culture. Requirements: BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, with 5+ years GMP microbiology or EM experience, including familiarity with regulatory interactions. HighValue: GMP cleanroom EM programs, contamination control, sterile manufacturing (fill–finish, lyophilization), data systems (MODA, LabVantage, TrackWise), microbiological techniques (MALDI-TOF, Vitek), work in a greenfield GMP setting, occasional off-hours work, and less than 5% travel. WorkSetup: initial location at Parkwood West, Carmel, IN, with permanent base in Lebanon, IN; occasional work at Indianapolis, with controlled cleanroom environment exposure.