Director - Operations GMP Laboratories Lilly Medicine Foundry

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

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.

In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations. This will require significant collaboration, creativity and resilience as the Lilly Medicine Foundry goes from design, to start-up, and to steady-state operations.

Position Summary

The Director of Operations for Analytical GMP Laboratories will lead all aspects of GMP analytical operations at the Lilly Medicine Foundry. This role oversees 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.

• Strategic Leadership & Operational Oversight – Lead QC laboratory operations, capability buildout, and maintain continuous inspection readiness; drive lab design, commissioning, workflow optimization, and implementation of 5S systems; own GMP compliance, quality systems, and data integrity standards across all analytical operations.
• Team Development & Leadership – Build and develop high-performing teams; lead hiring, onboarding, training, mentorship, and performance management; foster a culture of safety, quality, and continuous improvement.
• Equipment & Technology Management – 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.
• Operational Excellence – Manage capacity planning, scheduling, and laboratory inventories; oversee sample intake, chain of custody, and timely result release; ensure robust deviation management, investigations, and CAPA implementation.
• Safety & Compliance – Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation; ensure compliance with regulatory requirements, SOPs, GDP, and method standards.
• Cross-Functional Collaboration – Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy.

• 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.

• Experience with product development, including technical transfer of analytical methods into manufacturing operations.
• 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…