Principal Scientist GMP Microbiology Lilly Medicine Foundry
Eli Lilly and Company
August 13, 2026
On-site
Indianapolis, IN
Operations
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.
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.