Advisor – GMP Testing Group Lilly Medicine Foundry

Lilly•Lebanon, IN

3d•Onsite

About The Position

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 (2026 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. Overview The Advisor/Sr Advisor– GMP Testing is a key technical and people leader within the Analytical GMP Laboratories at the Lilly Medicine Foundry. This role is responsible for delivering high quality, timely, and compliant GMP analytical testing in support of clinical and commercial manufacturing, development programs, and quality operations. The role provides scientific leadership, operational oversight, and strategic direction to ensure method readiness, robust analytics, inspection readiness, and a high performing testing organization. The ideal candidate is an inclusive leader who brings deep technical expertise, a strong quality mindset, and the ability to develop talent, drive operational excellence, and introduce new analytical technologies.

Requirements

BS/MS/PhD in Chemistry, Biology, Chemical Engineering, or related scientific discipline.
Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles.
Experience leading GMP analytical testing teams.
Demonstrated skill in managing investigations, deviations, CAPAs, and regulatory interactions.
Strong technical understanding of analytical method lifecycle requirements under GMP.

Nice To Haves

Experience with product development, including technical transfer of analytical methods into manufacturing operations.
Track record of implementing new technologies and driving operational excellence.
Excellent communication, organizational, and leadership skills.
Demonstrated ability to drive and accept change.
Good interpersonal skills and a sustained tendency for collaboration.
Ability to prioritize multiple activities and manage ambiguity.

Responsibilities

Provide scientific and technical leadership for GMP analytical testing activities.
Ensure analytical methods are fitforpurpose and aligned with regulatory and lifecycle expectations.
Lead method readiness activities including method qualification, validation, transfer, troubleshooting, and ongoing lifecycle management.
Stay current with emerging analytical technologies and implement improvements to enhance efficiency, robustness, and compliance.
Ensure all laboratory testing operations comply with cGMP, GDP, and internal quality standards, including data integrity principles (ALCOA+).
Maintain a constant state of inspection readiness; lead or support internal, external, and regulatory audits.
Own and manage quality events (deviations, investigations, CAPAs, change controls) within the testing function, ensuring sciencebased, timely documentation.
Champion highquality data review, batch record review, and adherence to Good Documentation Practices.
Lead daytoday GMP testing operations, ensuring ontime test execution and timely delivery of accurate, compliant results.
Oversee sample management, chain of custody, workflow prioritization, and coordination to meet manufacturing and supply timelines.
Manage instrument and equipment lifecycle: procurement, installation, qualification (IQ/OQ/PQ), calibration, maintenance, and retirement.
Drive continuous optimization of workflows, turnaround time, and resource utilization.
Forecast, plan, and allocate personnel, equipment, and consumables to meet routine and nonroutine testing demands.
Manage laboratory inventory and ensure uninterrupted availability of critical materials, reagents, and supplies.
Use metrics and capacity models to anticipate future needs and support Foundry planning.
Lead, coach, and develop a team of analysts and scientists, promoting a culture of safety, quality, collaboration, and continuous improvement.
Oversee hiring, onboarding, training curricula, and qualification matrices.
Implement crosstraining to broaden team capability, strengthen flexibility, and increase operational resilience.
Provide performance feedback, career development support, and succession planning.
Drive deployment of new instruments, digital tools, and advanced analytical technologies within the GMP testing function.
Ensure laboratory instruments and data systems comply with data integrity, cybersecurity, and validation requirements.
Champion adoption of modern tools that improve data quality, testing efficiency, and operational reliability.
Partner with QA, Manufacturing, Analytical Development, and Technical Services to support product release, stability programs, investigations, and regulatory submissions.
Act as a liaison for analytical method transfers within the Lilly network and coordination with external testing partners.
Align analytical priorities across functions to ensure seamless support for site operations.
Prepare and present operational metrics, dashboards, and performance indicators to site leadership and governance bodies.
Contribute to strategic planning for analytical capabilities, instrumentation growth, and longterm laboratory infrastructure.
Use datadriven insights to optimize operations, improve predictability, and elevate testing performance.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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