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. 

Key Responsibilities 

Technical Leadership & Analytical Strategy 

• 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. 

Compliance, Quality, & Inspection Readiness 

• 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. 

Operational Management 

• 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. 

Resource & Capacity Planning 

• 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. 

People Leadership & Talent Development 

• 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. 

Instrumentation, Digital Systems & Technology Enablement 

• 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. 

CrossFunctional & Network Collaboration 

• 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. 

Governance, Metrics & Reporting 

• 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. 

Minimum Qualifications 

• 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. 

Additional Skills and Preferences: 

• 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. 

Other Information:  

• Initial location at Lilly Technology Center, Indianapolis.    

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

• Flexibility to work from Indianapolis (or other Lilly sites) may be required throughout 2026 and 2027.  

• 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.