Associate Director - GMP Analytical Operations Lilly Medicine Foundry

Position Summary

The GMP Operations Associate Director position seeks a collaborative, inclusive, and energetic leader who will be accountable for overseeing startup, scale-up, and steady-state operations, ensuring laboratory capability, GMP compliance, and digital enablement. The position requires strategic leadership, operational excellence, and a strong quality culture to support manufacturing and regulatory commitments. The GMP Operations group will consist of high level technical members focused on the implementation of laboratory instrument, new technologies and laboratory efficiency.

This position involves working cross-functionally within the site and across the network to develop strategic laboratory operations and will ensure appropriate capacity, capabilities and business processes are developed, implemented and sustained to ensure the laboratory staff can perform work activities in an efficient and compliant manner.

• Lead QC laboratory operations, capability buildout, and maintain continuous inspection readiness.

• Oversee instrumentation selection, URS development, and full lifecycle management (IQ/OQ/PQ, PM, calibration, troubleshooting, decommissioning).
• Ensure compliance with CQV/CSV and change control processes.

• Build and develop high-performing teams, lead hiring, onboarding, training, mentorship, and performance management.

• Foster a culture of safety, quality, and continuous improvement.

• Manage capacity planning, scheduling, and laboratory inventories.

• Ensure compliance with regulatory requirements, SOPs, GDP, and method standards.

• Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy.

• B.S. or M.S. in chemistry, chemical engineering, biology, or related field with 10+ years relevant foundational experiences in GMP laboratory equipment commissioning qualification validation.

• Extensive experience with analytical instrument 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.

• Demonstrated ability to drive and accept change.

• Good interpersonal skills and a sustained tendency for collaboration.

• Demonstrated success in persuasion, influence, and negotiation.

• Ability to prioritize multiple activities and manage ambiguity.
• Must possess strong communication (oral, written), organizational, and leadership skills.

• Initial location at Lilly Medicine Foundry Office in Carmel, Indiana.
• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
• 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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