Advisor Projects & Strategy Analytical GMP Laboratories Lilly Medicine Foundry

Role Summary

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. Initial location at Lilly Technology Center, Indianapolis;

permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. Some travel (0–10%) may be required.

• 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.

• Required:
  
  10+ years of experience in analytical development, GMP laboratories, or CMC functions.
• Required:
  
  Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks.
• Preferred:
  Proven cross-functional leadership experience.
• Preferred:
  Experience across synthetic and biological modalities.
• Preferred:
  Familiarity with PAT, automation, and high-throughput workflows.
• Preferred:
  Continuous improvement mindset with demonstrated CI experience.
• Preferred:
  Strong strategic thinking, influence, and stakeholder management skills.

• Initial location at Lilly Technology Center, Indianapolis.
• Permanent location at the 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.