Director, Environmental Monitoring & Microbiology GMP Laboratories Lilly Medicin
Scorpion Therapeutics, Indianapolis, Indiana, us, 46262
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. 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; 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 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. Qualifications
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. Skills
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. Education
BS/MS/PhD degree in Microbiology, Biology, Biochemistry, or related scientific discipline. Additional Requirements
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.
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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. 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; 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 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. Qualifications
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. Skills
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. Education
BS/MS/PhD degree in Microbiology, Biology, Biochemistry, or related scientific discipline. Additional Requirements
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.
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