Director, Environmental Monitoring & Microbiology GMP Laboratories Lilly Medicin
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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. Key Responsibilities
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 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). 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 embedded into facility design and operations. Support technology transfers and global microbiology initiatives, representing the microbiology function in global forums. People Leadership
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. Governance & Reporting
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. Minimum Qualifications
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. Additional Skills and Preferences:
Proven track record of leading crossfunctional 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. Other Information:
Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
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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. Key Responsibilities
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 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). 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 embedded into facility design and operations. Support technology transfers and global microbiology initiatives, representing the microbiology function in global forums. People Leadership
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. Governance & Reporting
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. Minimum Qualifications
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. Additional Skills and Preferences:
Proven track record of leading crossfunctional 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. Other Information:
Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
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