Principal Scientist GMP Microbiology Lilly Medicine Foundry

Principal Scientist, GMP QC Microbiology — Analytical GMP Laboratories (AGL)

Responsibilities:

• Perform and oversee sterility, bioburden, microbial limits, and water system testing; serve as primary data reviewer for batch disposition.
• Conduct microbial identification; maintain site isolate library; support EM activities as back-up.
• Lead method validations, transfers, and verifications; author protocols, summary reports, and change controls for methods/specifications/SOPs.
• Support qualification of laboratory equipment; evaluate new rapid microbiological methods (RMM).
• Lead OOS/OOT and other laboratory investigations; author deviation reports; drive CAPA to closure with QA.
• Maintain inspection-ready documentation; serve as SME during inspections/audits; update SOPs for evolving requirements.
• Develop/deliver training for junior analysts (methods, aseptic technique, cGMP); maintain training records/competency matrices; partner on workflow and continuous improvement.
• Ensure safe execution of lab/cleanroom/manufacturing support activities per procedures and GMP expectations.

Minimum Qualifications:

• BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related.
• BS 5+ years or MS 3+ years in cGMP pharmaceutical microbiology (compendial execution, investigation authoring, mentoring).
• Authorized to work in the U.S. full-time; Lilly does not sponsor visas.

Preferred Skills:

• Aseptic/sterile drug operations (fill–finish, lyophilization).
• EM data systems (MODA, LabVantage, Metasys) and QMS (TrackWise, Veeva Vault).
• RMM platforms (BacT/ALERT, Bactec, Milliflex, NAT/PCR sterility) and familiarity with LIMS/ELN/QMS.
• Microbial ID techniques (MALDI-TOF, Vitek, Gram stain).
• Greenfield/start-up lab experience (SOPs from scratch, equipment qualification, building quality culture).

Benefits/Compensation (as stated):

• Anticipated wage: $65,250–$169,400; may be eligible for a company bonus.
• Comprehensive benefits include 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits.

Additional info (role logistics):

• Location: Parkwood West (initial) and Lilly Medicine Foundry (permanent); <5% domestic travel; work in ISO 5–8 controlled cleanrooms; occasional off-hours/on-call; physical gowning/standing/walking as required.