Analytical GMP Strategy & Compliance Leader 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.

Organization and Position Overview: 

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 (2025 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 Analytical GMP Strategy & Compliance Director role, a technical-track position, seeks a collaborative, inclusive, and energetic leader who will be accountable for providing strategic direction/leadership to ensure that analytical activities within the Lilly Medicine Foundry to support the production of synthetic and biologic drug substance processes comply with Good Manufacturing Practices (GMP) regulations. This role will partner effectively with customer groups/business partners and act as a resource to identify and implement best practices, resolve and/or remediate complex/multi-site/cross-functional issues, and implement solutions that will help foster a laboratory GMP mindset.  

In addition, the Director will be responsible for establishing and maintaining a comprehensive GMP framework for analytical operations, ensuring compliance with relevant regulations and guidelines. The Director will supervise and manage a staff of technical GMP team members and will ensure the quality and reliability of analytical data used for product development, manufacturing, and regulatory submissions. This position will be key to ensuring a strong GMP culture and establishing a safety, quality and continuous improvement focused mindset within the organization. 

Responsibilities: 

• Drive implementation of GMP analytical strategies to enable drug substance production at the Lilly Medicine Foundry. 

• Work with business SMEs and stakeholders to define, develop, and implement business processes to help ensure effective use of GMP analytical solutions; Refine business requirements in collaboration with SMEs and stakeholders. 

• Represent business requirements in vendor discussions. 

• Strategic deployment of GMP analytical solutions. 

• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, PAT, and modeling and simulation).