Eli Lilly and Company

Director – Operations, GMP Laboratories

Eli Lilly and Company

full-time

Posted on:

Location Type: Office

Location: Indianapolis • United States

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Salary

💰 $148,500 - $257,400 per year

Job Level

Lead

About the role

  • Lead all aspects of GMP analytical operations at the Lilly Medicine Foundry
  • Oversee startup, scale-up, and steady-state operations, ensuring laboratory capability, GMP compliance, and digital enablement
  • Drive lab design, commissioning, workflow optimization, and implementation of 5S systems
  • Own GMP compliance, quality systems, and data integrity standards across all analytical operations
  • Build and develop high-performing teams; lead hiring, onboarding, training, mentorship, and performance management
  • Oversee instrumentation selection, URS development, and full lifecycle management (IQ/OQ/PQ, PM, calibration, troubleshooting, decommissioning)
  • Manage capacity planning, scheduling, and laboratory inventories
  • Ensure robust deviation management, investigations, and CAPA implementation
  • Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation
  • Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy

Requirements

  • Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline
  • Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles
  • Extensive experience with CQV/CSV, quality systems, and regulatory compliance
  • Strong strategic thinking, influence, and stakeholder management skills
  • Proficiency in digital QC systems (LIMS, QMS, Empower, SAP, ELN) and continuous improvement methodologies
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP complianceanalytical operationslaboratory capabilityworkflow optimizationinstrumentation selectioncapacity planningdeviation managementquality systemsregulatory compliancecontinuous improvement methodologies
Soft Skills
leadershipteam developmentstrategic thinkinginfluencestakeholder managementmentorshipperformance managementcommunicationproblem-solvingsafety culture
Certifications
PhD in ChemistryPhD in BiochemistryBS in ChemistryBS in BiochemistryMS in ChemistryMS in Biochemistry