Eli Lilly
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
Eli Lilly, Lebanon, Indiana, United States, 46052
Lilly Medicine Foundry Analytical Gmp Strategy & Compliance Director
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 (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). Identify opportunities for process improvement and implementing changes to enhance efficiency and compliance. Implement procedures and controls to ensure the accuracy, reliability, and security of analytical data, including data acquisition, analysis, and reporting. Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. Welcome varied perspectives to create new solutions. Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP, and GMP requirements. Basic Requirements
Ph.D. in chemistry, biology, or related field with 6+ years relevant pharmaceutical experience; OR B.S. or M.S. with 15+ years of experience. Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods. Fundamental knowledge of cGMP compliance requirements and cGMP experience. Additional Preferences
Demonstrated ability to drive and accept change. Good interpersonal skills and a sustained tendency for collaboration. Demonstrated success in persuasion, influence, and negotiation. Ability to prioritize multiple activities and manage ambiguity. Must possess strong communication (oral, written), organizational, and leadership skills. Other Information
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 2025 and 2026. 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.
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 (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). Identify opportunities for process improvement and implementing changes to enhance efficiency and compliance. Implement procedures and controls to ensure the accuracy, reliability, and security of analytical data, including data acquisition, analysis, and reporting. Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. Welcome varied perspectives to create new solutions. Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP, and GMP requirements. Basic Requirements
Ph.D. in chemistry, biology, or related field with 6+ years relevant pharmaceutical experience; OR B.S. or M.S. with 15+ years of experience. Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods. Fundamental knowledge of cGMP compliance requirements and cGMP experience. Additional Preferences
Demonstrated ability to drive and accept change. Good interpersonal skills and a sustained tendency for collaboration. Demonstrated success in persuasion, influence, and negotiation. Ability to prioritize multiple activities and manage ambiguity. Must possess strong communication (oral, written), organizational, and leadership skills. Other Information
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 2025 and 2026. 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.