Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry
Eli Lilly and Company
August 13, 2026
On-site
Lebanon, IN
Operations
About The Role
Principal Scientist, GMP EM is the technical owner for cleanroom environmental monitoring (EM) and utility monitoring programs supporting GMP manufacturing operations within the Medicine Foundry Analytical GMP Laboratory. Oversees daily EM team operations, ensures timely/compliant monitoring execution across classified areas, supports contamination control/production readiness, provides technical guidance, develops EM staff, leads/supports root cause investigations and excursion/deviation escalations, and partners with Manufacturing, QC, Facilities, and QA to maintain inspection readiness while ensuring cGMP/ALCOA+ and quality/regulatory compliance.
What You’ll Do
- Own the Cleanroom EM Program (sampling strategy, risk assessments, alert/action limits)
- Coordinate shift-based EM activities on the manufacturing floor
- Support EMPQs, cleanroom/utility readiness, and validation for GMP startup and ongoing operations
- Ensure data integrity by reviewing/approving EM and lab records/SOPs in MODA and LabVantage
- Maintain inspection-ready equipment/method readiness (qualification, calibration, maintenance)
- Lead investigations for excursions/deviations and drive on-time CAPA closure
- Maintain inspection readiness; present EM data to regulators
- Train/mentor EM analysts and technicians; promote aseptic best practices and “Right First Time”
- Plan staffing/resources, manage budget, and drive continuous improvement
- Lead safety and GMP-compliant work
Minimum Qualifications
- BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related life science
- 5+ years GMP pharmaceutical microbiology or EM experience, including regulator interaction
- Authorized to work in the U.S. full-time; visa sponsorship not provided
Additional Skills/Preferences
- Aseptic manufacturing/sterile drug operations (fill–finish, lyophilization)
- EM data systems: MODA, LabVantage, Metasys; QMS (TrackWise, Veeva Vault)
- EM sampling instruments (e.g., Met One, Climent, MAS 100, Lighthouse, PMS)
- Microbial ID (MALDI-TOF, Vitek, Gram stain) and bioburden/endotoxin testing
- Qualification curricula/training plan development; greenfield/startup GMP experience
Location/Work Conditions
Parkwood West (Carmel, IN) initially; occasional work at Lilly Technology Center (Indianapolis, IN); permanent at Lilly Medicine Foundry (Lebanon, IN). <5% domestic travel; cleanroom ISO 5–8 gowning; possible off-hours/weekend/on-call.
Compensation/Benefits (as stated)
- Anticipated wage: $65,250–$169,400; company bonus for full-time equivalents (based on performance)
- Eligible for medical/dental/vision/prescription, 401(k), pension, vacation, flexible benefits, life insurance, time off/leave, and well-being benefits.
Principal Scientist, GMP EM is the technical owner for cleanroom environmental monitoring (EM) and utility monitoring programs supporting GMP manufacturing operations within the Medicine Foundry Analytical GMP Laboratory. Oversees daily EM team operations, ensures timely/compliant monitoring execution across classified areas, supports contamination control/production readiness, provides technical guidance, develops EM staff, leads/supports root cause investigations and excursion/deviation escalations, and partners with Manufacturing, QC, Facilities, and QA to maintain inspection readiness while ensuring cGMP/ALCOA+ and quality/regulatory compliance.
What You’ll Do
- Own the Cleanroom EM Program (sampling strategy, risk assessments, alert/action limits)
- Coordinate shift-based EM activities on the manufacturing floor
- Support EMPQs, cleanroom/utility readiness, and validation for GMP startup and ongoing operations
- Ensure data integrity by reviewing/approving EM and lab records/SOPs in MODA and LabVantage
- Maintain inspection-ready equipment/method readiness (qualification, calibration, maintenance)
- Lead investigations for excursions/deviations and drive on-time CAPA closure
- Maintain inspection readiness; present EM data to regulators
- Train/mentor EM analysts and technicians; promote aseptic best practices and “Right First Time”
- Plan staffing/resources, manage budget, and drive continuous improvement
- Lead safety and GMP-compliant work
Minimum Qualifications
- BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related life science
- 5+ years GMP pharmaceutical microbiology or EM experience, including regulator interaction
- Authorized to work in the U.S. full-time; visa sponsorship not provided
Additional Skills/Preferences
- Aseptic manufacturing/sterile drug operations (fill–finish, lyophilization)
- EM data systems: MODA, LabVantage, Metasys; QMS (TrackWise, Veeva Vault)
- EM sampling instruments (e.g., Met One, Climent, MAS 100, Lighthouse, PMS)
- Microbial ID (MALDI-TOF, Vitek, Gram stain) and bioburden/endotoxin testing
- Qualification curricula/training plan development; greenfield/startup GMP experience
Location/Work Conditions
Parkwood West (Carmel, IN) initially; occasional work at Lilly Technology Center (Indianapolis, IN); permanent at Lilly Medicine Foundry (Lebanon, IN). <5% domestic travel; cleanroom ISO 5–8 gowning; possible off-hours/weekend/on-call.
Compensation/Benefits (as stated)
- Anticipated wage: $65,250–$169,400; company bonus for full-time equivalents (based on performance)
- Eligible for medical/dental/vision/prescription, 401(k), pension, vacation, flexible benefits, life insurance, time off/leave, and well-being benefits.