Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry
Eli Lilly and Company
August 13, 2026
On-site
Indianapolis, IN
Operations
About The Role
Principal Scientist, GMP EM is the technical owner for cleanroom EM and utility monitoring programs supporting GMP manufacturing at the Medicine Foundry Analytical GMP Laboratory. Oversees daily EM operations, ensures compliant monitoring execution in classified areas, supports contamination control/production readiness, provides technical guidance, leads cleanroom/environmental excursion escalation, and partners with Manufacturing, QC, Facilities, and QA for inspection readiness. Leads/supports root cause investigations and ensures adherence to cGMP/ALCOA+ and applicable quality/regulatory requirements.
What You'll Do
- Own cleanroom/utility EM program (sampling strategy, risk assessments, alert/action limits).
- Coordinate shift-based EM activities; respond to real-time environmental/production needs.
- Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation.
- Ensure data integrity (review/approve EM & lab records, SOPs, controlled documents in MODA/LabVantage).
- Keep equipment/methods inspection-ready (qualification, calibration, maintenance).
- Lead root cause investigations; drive CAPA closure.
- Maintain inspection readiness and present EM data during regulatory inspections.
- Train/mentor EM analysts and technicians; promote aseptic best practices/“Right First Time”.
- Optimize staffing/resources, budget, and continuous improvement.
- Lead by example on safety and full GMP compliance.
Minimum Qualifications
- BS/MS in Microbiology/Biology/Biochemistry/Pharmaceutical Sciences or related.
- 5+ years GMP pharmaceutical microbiology or EM experience, including regulatory interaction.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Preferred Skills
- Aseptic/sterile drug operations (fill–finish, lyophilization).
- EM/quality systems (MODA, LabVantage, Metasys, TrackWise, Veeva Vault).
- EM sampling instruments (e.g., Met One, Climent, Air Ideal, MAS 100, Lighthouse).
- Microbial ID (MALDI-TOF, Vitek, Gram stain) and bioburden/endotoxin testing.
- Experience with qualification curricula/training plans; greenfield/start-up GMP.
Additional Information
- Location: Parkwood West (Carmel, IN) initially; permanent at Lilly Medicine Foundry (Lebanon, IN). Travel <5% domestic.
- Regular ISO 5–8/Grade A–D gowning; possible off-hours/weekend/on-call.
Compensation/Benefits (as stated)
- Anticipated base pay: $65,250–$169,400.
- Eligible for company bonus (full-time equivalent).
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time-off/leave, well-being (EAP/fitness/clubs).
Principal Scientist, GMP EM is the technical owner for cleanroom EM and utility monitoring programs supporting GMP manufacturing at the Medicine Foundry Analytical GMP Laboratory. Oversees daily EM operations, ensures compliant monitoring execution in classified areas, supports contamination control/production readiness, provides technical guidance, leads cleanroom/environmental excursion escalation, and partners with Manufacturing, QC, Facilities, and QA for inspection readiness. Leads/supports root cause investigations and ensures adherence to cGMP/ALCOA+ and applicable quality/regulatory requirements.
What You'll Do
- Own cleanroom/utility EM program (sampling strategy, risk assessments, alert/action limits).
- Coordinate shift-based EM activities; respond to real-time environmental/production needs.
- Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation.
- Ensure data integrity (review/approve EM & lab records, SOPs, controlled documents in MODA/LabVantage).
- Keep equipment/methods inspection-ready (qualification, calibration, maintenance).
- Lead root cause investigations; drive CAPA closure.
- Maintain inspection readiness and present EM data during regulatory inspections.
- Train/mentor EM analysts and technicians; promote aseptic best practices/“Right First Time”.
- Optimize staffing/resources, budget, and continuous improvement.
- Lead by example on safety and full GMP compliance.
Minimum Qualifications
- BS/MS in Microbiology/Biology/Biochemistry/Pharmaceutical Sciences or related.
- 5+ years GMP pharmaceutical microbiology or EM experience, including regulatory interaction.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Preferred Skills
- Aseptic/sterile drug operations (fill–finish, lyophilization).
- EM/quality systems (MODA, LabVantage, Metasys, TrackWise, Veeva Vault).
- EM sampling instruments (e.g., Met One, Climent, Air Ideal, MAS 100, Lighthouse).
- Microbial ID (MALDI-TOF, Vitek, Gram stain) and bioburden/endotoxin testing.
- Experience with qualification curricula/training plans; greenfield/start-up GMP.
Additional Information
- Location: Parkwood West (Carmel, IN) initially; permanent at Lilly Medicine Foundry (Lebanon, IN). Travel <5% domestic.
- Regular ISO 5–8/Grade A–D gowning; possible off-hours/weekend/on-call.
Compensation/Benefits (as stated)
- Anticipated base pay: $65,250–$169,400.
- Eligible for company bonus (full-time equivalent).
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time-off/leave, well-being (EAP/fitness/clubs).