Principal Scientist, GMP Microbiology – Critical Utilities Qualification & Monitoring

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry — the first-ever facility to combine research and manufacturing in a single location, expanding capacity for clinical trial medicines while reducing costs and environmental impact.

Analytical GMP Laboratories (AGL) supports GMP testing across the Lilly Medicine Foundry (LMF) and the broader Product Research & Development (PRD) network, spanning environmental monitoring, microbiology, GMP testing, raw materials, and cleaning/investigations. AGL sits at the intersection of science and quality — this role offers the opportunity to shape the analytical compliance program from the ground up and help drive quality culture at a cutting-edge facility.

The Scientist, GMP Microbiology supports the qualification and routine monitoring of critical utility systems (WFI, PW, clean steam, compressed air, and process gases) at the Lilly Medicine Foundry, ensuring they consistently meet microbiological, chemical, and particulate requirements. The role partners with Utilities, PT&E, Manufacturing, and Quality, serves as an escalation point for utility excursions, and supports root cause investigations in line with cGMP and ALCOA+.

• Build the Utility Monitoring Program: Develop sampling plans, point-of-use maps, and risk-based alert/action levels aligned with the contamination control strategy.

• Drive Qualification Readiness: Author, execute, and summarize protocols and reports for phased water and gas system qualification (USP, EP, JP, ISPE, Lilly GQS).

• Execute Routine Monitoring: Oversee utility sampling and testing (bioburden, endotoxin, TOC, conductivity, microbial , particulates, steam quality, gas testing) within hold times and aseptic technique.

• Turn Data into Insight: Trend results, identify adverse trends early, and prepare periodic trend and system review reports.

• Ensure Data Integrity: Support LIMS (MODA) configuration and review records, SOPs, and controlled documents to keep data audit-ready.

• Lead Investigations That Matter: Support deviation, OOS/OOT, excursion, CAPA, and change control activities with Utilities, PT&E, and Quality.

• Champion Inspection Readiness: Keep practices aligned with cGMP, FDA, EU GMP Annex 1, and USP /, and present utility data during audits and inspections.

• Build the Team: Train sampling personnel and coordinate contract lab partners, instilling a "Right First Time" culture.

• BS or MS in Microbiology, Biology, Chemistry, or a related life science discipline.

• 3+ years of experience in GMP microbiology or utility monitoring, including water and/or process gas sampling and investigations/CAPA.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Greenfield or start-up GMP facility experience, including commissioning and qualification.

• Hands-on experience…