Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry

About the role

The Principal Scientist, GMP EM serves as the technical owner for cleanroom EM and utility monitoring programs supporting GMP manufacturing operations within the Medicine Foundry Analytical GMP Laboratory. This role oversees daily EM team operations, ensures timely and compliant monitoring execution across classified manufacturing areas, and supports contamination control and production readiness.

Responsibilities

• Own the Cleanroom EM Program: Serve as the site's technical SME for cleanroom and utility monitoring programs — shaping sampling strategy, risk assessments, alert/action limits, and alignment with the site's contamination control strategy from the ground up.
• Be a Visible Partner on the Manufacturing Floor: Coordinate shift-based EM activities in classified production areas, support manufacturing operations directly, and respond in real time to production needs and environmental concerns.
• Drive Readiness for a First-of-Its-Kind Facility: Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities that get manufacturing started — and keep it running at GMP standard.
• Ensure Data Integrity Across Systems: Review and approve EM and lab records, SOPs, and controlled documents, keeping data accurate and audit-ready in systems like MODA and LabVantage.
• Keep Equipment and Methods Inspection-Ready: Own instrument qualification, calibration, maintenance, and method readiness so testing never misses a beat.
• Lead Investigations That Matter: Drive root cause investigations for environmental excursions and manufacturing deviations, partnering across Manufacturing, QA, QC, and Facilities to close CAPAs on time.
• Champion Inspection Readiness: Keep practices and data aligned with cGMP, FDA, EMA, EU GMP Annex 1, USP , ISO 14644, and 21 CFR 210/211 — and be the one who confidently presents EM data during regulatory inspections.
• Build the Team: Train, mentor, and develop EM analysts and technicians, instilling aseptic best practices and a "Right First Time" quality culture.
• Optimize How the Work Gets Done: Plan staffing and resources to meet production schedules, manage budget, and drive continuous improvement in efficiency and cost.
• Lead by Example on Safety: Ensure all lab, cleanroom, and manufacturing support work is performed safely and in full GMP compliance.

Requirements

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field.
• 5+ years experience in GMP pharmaceutical microbiology or EM experience including experience interacting with regulatory agencies.

Qualifications

• Minimum qualifications: BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field. 5+ years experience in GMP pharmaceutical microbiology or EM experience including experience interacting with regulatory agencies.