Advisor – GMP Testing Group Lilly Medicine Foundry

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. 

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 Documentat