Lead Scientist, GMP Environmental Monitoring

Eli Lilly and Company; Indiana; On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly is seeking a Principal Scientist, GMP EM to own the cleanroom EM program and lead a team ensuring compliant monitoring across classified manufacturing areas. You will guide testing, investigations, and data integrity while partnering with Manufacturing, QA, QC, and Facilities to maintain inspection readiness.

Leadership includes developing EM technicians, ensuring equipment qualification, and driving readiness for a first-of-its-kind facility, all within cGMP and regulatory expectations.

Qualifications

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related life science field.
• 5+ years in GMP pharmaceutical microbiology or EM with regulatory interactions.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Own the Cleanroom EM program and shape sampling strategy and alignment with contamination control.
• Coordinate shift-based EM activities in classified production areas and respond to needs.
• Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities.
• Review EM records, SOPs, and controlled documents for audit readiness.
• Own instrument qualification, calibration, maintenance, and method readiness.
• Lead investigations for environmental excursions and CAPA closure with cross-functional teams.
• Ensure data integrity and compliance with cGMP, FDA, and EMA standards.
• Train and mentor EM analysts and technicians, promoting aseptic best practices.
• Plan staffing and resources to meet production schedules and budgets.
• Maintain safety and full GMP compliance across activities.
• Present EM data confidently during regulatory inspections.

Skills

GMP experience

Environmental monitoring

Microbiology

Regulatory interaction

Education

BS or MS in Microbiology

Tools

MODA

LabVantage

Metasys

TrackWise

Veeva Vault

Job description

Lilly is seeking a Principal Scientist, GMP EM to own the cleanroom EM program and lead a team ensuring compliant monitoring across classified manufacturing areas. You will guide testing, investigations, and data integrity while partnering with Manufacturing, QA, QC, and Facilities to maintain inspection readiness.

Leadership includes developing EM technicians, ensuring equipment qualification, and driving readiness for a first-of-its-kind facility, all within cGMP and regulatory expectations.