Associate Director - GMP Analytical Operations Lilly Medicine Foundry

Associate Director - GMP Analytical Operations Lilly Medicine Foundry page is loaded## Associate Director - GMP Analytical Operations Lilly Medicine Foundry locations:
US, Lebanon INtime type:
Full time posted on:
Posted Todayjob requisition :
R-101450

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 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.
** Key Responsibilities
**** Strategic Leadership & Operational Oversight
*** 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.
** Cross-Functional Collaboration
*** Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy.
** Qualifications
* ** 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.
** Additional Skills and Preferences:
*** 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.
** Other Information:
*** 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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