Director, Environmental Monitoring & Microbiology GMP Laboratories Lilly Medicine Foundry

Role Summary

The Director of Environmental Monitoring (EM) & Microbiology provides strategic and operational leadership across all microbiology, EM, and contamination control functions within Analytical GMP Laboratories. This role oversees two major operational arms: the EM program and microbiology testing operations, ensuring full alignment with cGMP expectations and Lilly site/global quality objectives. The Director also serves as the microbiology SME supporting site C&Q activities, facility and utility monitoring strategies, and implementation of the Contamination Control Strategy (CCS).

The role ensures a state of continuous inspection readiness, drives modernization of EM and microbiology capabilities, and strengthens contamination control measures across manufacturing operations.

• Define and execute the vision for GMP microbiology and EM programs, aligning with site and global quality strategies.
• Provide microbiology SME guidance for site commissioning & qualification (C&Q) activities, ensuring facility, utility, and equipment designs meet microbiological and contamination-control expectations.
• Serve as the microbiology SME for the Contamination Control Strategy (CCS), contributing to design, risk assessment, and lifecycle management of contamination control elements.
• Develop modernization strategies including rapid microbiological methods, automated trending, and real-time EM reporting.
• Ensure all EM and microbiology operations comply with cGMP, regulatory requirements, EHS standards, and global quality expectations.
• Maintain inspection readiness for EM and microbiology areas; lead microbial focused audits and regulatory inspections.
• Oversee microbiology related deviations, investigations, CAPA effectiveness, and support ALCOA+ data integrity principles.
• Lead two core operational arms:
  Environmental Monitoring Program;
  Microbiology Testing Operations, including routine and non-routine sampling, data trending, and testing method qualification/verification.
• Oversee facility and utility monitoring programs, ensuring appropriate monitoring strategies for clean rooms, water systems, compressed gases, and critical utilities.
• Ensure readiness and qualification/calibration of EM and microbiology instrumentation (air samplers, incubators, particle counters, LIMS/MODA systems).
• Partner with Manufacturing, QA, Engineering, Technical Services, and C&Q teams to strengthen contamination control strategies and ensure EM/microbiology expectations are embedded into facility design and operations.
• Support technology transfers and global microbiology initiatives, representing the microbiology function in global forums.
• Lead and develop teams across both microbiology testing and EM operations; manage staffing, training, qualification, and competency programs.
• Foster a culture of safety, quality, ownership, and continuous improvement.
• Develop and present EM and microbiology performance metrics, dashboards, contamination control KPIs, and quality risk indicators to site leadership.
• Contribute to strategic planning for microbiology capabilities, including laboratory and cleanroom infrastructure, modernization projects, and long-range capability investment.

• BS/MS/PhD degree in Microbiology, Biology, Biochemistry, or related scientific discipline.
• Ph.D. with 5+ years or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles.
• Minimum 5 years of experience in GMP microbiology, EM programs, or related QC functions within the pharmaceutical or biotechnology industry.
• Strong working knowledge of cGMPs, global regulatory expectations, and contamination control principles.
• Demonstrated experience leading EM and/or microbiology laboratory functions in a regulated environment.
• Experience supporting facility and utility qualification, cleanroom design, and contamination control strategy implementation.
• Expertise with rapid microbiological methods, digital microbiology, and/or automated EM technologies.

• Proven track record of leading cross functional teams and influencing decisions in a matrix organization.
• Experience interacting with regulatory agencies during inspections, audits, and technical discussions.
• Strong leadership capabilities with demonstrated success in talent development and building high performing teams.

• BS/MS/PhD degree in Microbiology, Biology, Biochemistry, or related scientific discipline.

• Initial location at Lilly Technology Center, Indianapolis.
• Permanent location at the Lilly Medicine Foundry in Lebanon, Indiana.
• Flexibility to work from Indianapolis (or other Lilly sites) may be required throughout 2026 and 2027.
• Position requires on-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.
• 0-10% travel required.