Advisor – GMP Testing Group Lilly Medicine Foundry

Role Summary

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.

• Provide scientific and technical leadership for GMP analytical testing activities.
• Ensure analytical methods are fit-for-purpose 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 science-based, timely documentation.
• Champion high-quality data review, batch record review, and adherence to Good Documentation Practices.
• Lead day-to-day GMP testing operations, ensuring on-time 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 cross-training 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 long-term laboratory infrastructure.
• Use data-driven insights to optimize operations, improve predictability, and elevate testing performance.

• Required:
  
  BS/MS/PhD in Chemistry, Biology, Chemical Engineering, or related scientific discipline.
• Required:
  
  Ph.D. with 5+ years…