Eli Lilly and Company
Director, Environmental Monitoring & Microbiology GMP Laboratories Lilly Medicin
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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.
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** Ensure all EM and microbiology operations comply with cGMP, regulatory requirements, EHS standards, and global quality expectations.**Minimum** **Qualifications** 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 **Additional Skills and Preferences:** Experience interacting with regulatory agencies during inspections, audits, and technical discussions. Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr
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** Ensure all EM and microbiology operations comply with cGMP, regulatory requirements, EHS standards, and global quality expectations.**Minimum** **Qualifications** 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 **Additional Skills and Preferences:** Experience interacting with regulatory agencies during inspections, audits, and technical discussions. Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr