Director, Environmental Monitoring & Microbiology GMP Laboratories Lilly Medicine Foundry

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

In the Project Delivery Phase and Startup Phase of the project (2026 to 2028), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations. This will require significant collaboration, creativity and resilience as the Lilly Medicine Foundry goes from design, to start-up, and to steady-state operations.

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 and drives modernization of EM and microbiology capabilities to strengthen contamination control across manufacturing operations.

Leadership & Strategy

• 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.

Compliance & Quality Systems

• 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.

Operational Management

• Lead two core operational arms:
• Environmental Monitoring Program — routine and non-routine sampling, data trending, alert/action management, EM readiness, and modernization initiatives.
• Microbiology Testing Operations — bioburden, endotoxin, identification, growth promotion, and microbial 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).

Cross Functional Collaboration

• Partner with Manufacturing, QA, Engineering, Technical Services, and C&Q teams to strengthen contamination control strategies and ensure EM/microbiology expectations are…