Advisor Projects & Strategy Analytical GMP Laboratories 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.

The Advisor/Sr Advisor of Project & Strategy for Analytical GMP Laboratories will lead clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry. This role drives phase‑appropriate, risk‑based analytical strategies from development through GMP execution, oversees strategic planning across CMC analytical deliverables, and partners cross‑functionally to align analytical strategy with compliance, capability build, and digital enablement.

• Define and lead phase‑appropriate, risk‑based analytical strategies to support clinical manufacturing.
• Develop integrated method readiness strategies, including validation and transfer across multiple modalities.
• Oversee CMC analytical activities, specifications, stability strategies, and lifecycle elements.

• Support digitalization initiatives and implementation of new technologies to enhance analytical workflows.
• Drive adoption of PAT, automation, and high‑throughput approaches for efficiency and compliance.

• Champion continuous improvement initiatives and analytical lifecycle performance metrics.
• Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle.

• Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercial objectives.
• Act as a key liaison for technology transfer and method strategy across Foundry operations.

• MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
• 10+ years of experience in analytical development, GMP laboratories, or CMC functions.
• Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks.

• Proven cross‑functional leadership experience.
• Experience across synthetic and biological modalities.
• Familiarity with PAT, automation, and high‑throughput workflows.
• Continuous improvement mindset with demonstrated CI experience.
• Strong strategic thinking, influence, and stakeholder management skills.

• 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.

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