Director, Environmental Monitoring & Microbiology GMP Laboratories Lilly Medicine Foundry

Lilly•Lebanon, IN

2d•Onsite

About The Position

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. Position 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.

Requirements

BS/MS/PhD degree in Microbiology, Biology, Biochemistry, or related scientific discipline.
Ph.D. with 5+ 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.

Nice To Haves

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.

Responsibilities

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 — 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 cleanrooms, 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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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