Eli Lilly and Company

Director, Environmental Monitoring – Microbiology GMP Laboratories

Eli Lilly and Company

full-time

Posted on:

Location Type: Hybrid

Location: Indianapolis • United States

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Salary

💰 $148,500 - $257,400 per year

Job Level

Lead

About the role

  • Define and execute the vision for GMP microbiology and EM programs
  • Provide microbiology SME guidance for site commissioning & qualification (C&Q) activities
  • Serve as the microbiology SME for the Contamination Control Strategy (CCS)
  • 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
  • Lead two core operational arms: Environmental Monitoring Program and Microbiology Testing Operations
  • Partner with Manufacturing, QA, Engineering, Technical Services, and C&Q teams
  • Lead and develop teams across both microbiology testing and EM operations
  • Develop and present EM and microbiology performance metrics and quality risk indicators to site leadership

Requirements

  • B S/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
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
microbiologyenvironmental monitoringGMPrapid microbiological methodsautomated trendingreal-time EM reportingcontamination controlfacility qualificationcleanroom designdigital microbiology
Soft Skills
leadershipteam developmentcommunicationcollaboration
Certifications
PhD in MicrobiologyBS/MS in BiologyBS/MS in Biochemistry