Sr. Director, Analytical GMP Testing Capabilities

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.

Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader with headquarters 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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

Organization and Position Overview:

Product Research & Development (PRD) advances the CMC development of Lilly’s diverse and expanding portfolio, covering both established and emerging therapeutic modalities across various disease areas. Our team blends innovation with technical excellence to transform scientific discoveries into life-changing medicines.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new PRD 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.

We are seeking a collaborative, inclusive, and visionary leader to serve as Senior Director, Analytical GMP Testing Capabilities. This role will shape and lead centralized GMP testing strategies and operations within Product Research and Development (PRD), supporting Lilly’s expanding pipeline across a broad range of molecular modalities. The successful candidate will work cross-functionally and in close partnership with the Lilly Medicine Foundry to establish and continuously improve processes that enable robust, reliable analytical capabilities. The successful candidate will be a key member of the Analytical Development leadership team.

Key Responsibilities:

• Define and implement GMP testing capabilities for clinical trial materials, ensuring alignment with PRD strategy and strategic investments such as the Medicine Foundry.
• Collaborate across PRD to deliver testing solutions that support a diverse and evolving portfolio of biological and synthetic modalities.
• Lead continuous improvement efforts and drive an integrated GMP testing strategy.
• Oversee laboratory operations with a strong focus on safety, regulatory compliance, and inspection readiness.
• Maintain a safe, compliant work environment by ensuring adherence to all applicable regulations.
• Integrate emerging technologies, new scientific insights, and evolving regulatory requirements into team practices and decision-making.
• Foster a high-performance team culture through coaching, mentoring, performance management, and career development; contributes to talent assessment and succession planning.
• Deliver testing capabilities that are both flexible and reliable, meeting the speed and quality expectations of a dynamic clinical development portfolio.

Basic Requirements:

• Ph.D. in analytical chemistry, biophysics, biochemistry, molecular/cell biology, or a related field, with relevant experience in the pharmaceutical industry; alternatively, B.S. or M.S. with 15+ years of experience equivalent to a Ph.D.-level chemist or biochemist.
• Proven leadership experience in establishing and managing GMP laboratories supporting clinical trials across multiple molecular modalities.

Additional Skills/Preferences:

• Strong foundational knowledge of cGMP and GLP compliance requirements.
• Deep understanding of quality and regulatory standards for analytical laboratories.
• Demonstrated creativity and innovation in developing improved products and