Principal Scientist GMP Microbiology Lilly Medicine Foundry
Eli Lilly and Company
August 13, 2026
On-site
Lebanon, IN
Operations
Principal Scientist, GMP QC Microbiology
What You’ll Do
- 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.
- Lead method validations, transfers, and verifications; author protocols/summary reports and change controls for test 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 closure with QA.
- Maintain documentation for inspection readiness; serve as SME during inspections/audits; update SOPs to reflect evolving standards.
- Train and mentor junior analysts on test methods, aseptic technique, and cGMP; maintain training/competency records.
- Ensure safe execution of lab/cleanroom/manufacturing support activities per approved procedures, cleanroom behaviors, and GMP.
Minimum Qualifications
- BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related field.
- BS: 5+ years; MS: 3+ years cGMP pharmaceutical microbiology experience (compendial methods, investigations, mentoring).
- Authorized to work in the US full-time; Lilly does not sponsor visas.
Additional Skills and Preferences
- Aseptic manufacturing/sterile drug product experience (fill–finish, lyophilization).
- EM data systems (MODA, LabVantage, Metasys) and QMS (TrackWise, Veeva Vault).
- RMM platforms (BacT/ALERT, Bactec, Milliflex, NAT/PCR sterility) and LIMS/ELN experience.
- Microbial ID techniques (MALDI-TOF, Vitek, Gram stain).
- Start-up/greenfield lab experience (build-out, SOP authoring, equipment qualification, quality culture).
Compensation/Benefits (as stated)
- Anticipated wage: $65,250–$169,400; eligible for company bonus and comprehensive benefits (incl. 401(k), medical/dental/vision, life/disability, time off/leave, well-being).
What You’ll Do
- 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.
- Lead method validations, transfers, and verifications; author protocols/summary reports and change controls for test 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 closure with QA.
- Maintain documentation for inspection readiness; serve as SME during inspections/audits; update SOPs to reflect evolving standards.
- Train and mentor junior analysts on test methods, aseptic technique, and cGMP; maintain training/competency records.
- Ensure safe execution of lab/cleanroom/manufacturing support activities per approved procedures, cleanroom behaviors, and GMP.
Minimum Qualifications
- BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related field.
- BS: 5+ years; MS: 3+ years cGMP pharmaceutical microbiology experience (compendial methods, investigations, mentoring).
- Authorized to work in the US full-time; Lilly does not sponsor visas.
Additional Skills and Preferences
- Aseptic manufacturing/sterile drug product experience (fill–finish, lyophilization).
- EM data systems (MODA, LabVantage, Metasys) and QMS (TrackWise, Veeva Vault).
- RMM platforms (BacT/ALERT, Bactec, Milliflex, NAT/PCR sterility) and LIMS/ELN experience.
- Microbial ID techniques (MALDI-TOF, Vitek, Gram stain).
- Start-up/greenfield lab experience (build-out, SOP authoring, equipment qualification, quality culture).
Compensation/Benefits (as stated)
- Anticipated wage: $65,250–$169,400; eligible for company bonus and comprehensive benefits (incl. 401(k), medical/dental/vision, life/disability, time off/leave, well-being).