Eli Lilly and Company
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Lilly is a global healthcare leader focused on discovering and delivering medicines to improve people’s lives. We are headquartered in Indianapolis, Indiana, with employees worldwide who work to advance science, manage disease, and support communities through philanthropy and volunteerism. We are looking for people who are determined to make life better for others.
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 enable Lilly to further develop innovative solutions to optimize manufacturing processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact. In the Project Delivery Phase and Startup Phase (2025 to 2028), roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, and implement the necessary systems and business processes required to support GMP operations. This will require collaboration, creativity, and resilience as the Lilly Medicine Foundry progresses from design to start-up and steady-state operations. Role
The Analytical GMP Strategy & Compliance Director is a technical-track position that seeks a collaborative, inclusive, and energetic leader who will be accountable for providing strategic direction and leadership to ensure analytical activities within the Lilly Medicine Foundry comply with Good Manufacturing Practices (GMP). This role will partner effectively with customer groups and business partners, identify and implement best practices, resolve complex issues, and foster a laboratory GMP mindset. It will also establish and maintain a comprehensive GMP framework for analytical operations, supervise a staff of technical GMP team members, and ensure the quality and reliability of analytical data used for product development, manufacturing, and regulatory submissions. The position will promote a strong GMP culture and a safety, quality, and continuous improvement 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 ensure effective use of GMP analytical solutions; refine requirements in collaboration with SMEs and stakeholders. Represent business requirements in vendor discussions. Strategically deploy GMP analytical solutions. Demonstrate learning agility and the ability to apply scientific concepts across multiple areas (e.g., chemistry, PAT, modeling and simulation). Identify opportunities for process improvement 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; promote continued technical and professional growth, excellence, and knowledge sharing. Plan and manage short- and long-term development activities; develop and review technical agendas and timelines; allocate resources to accomplish projects and communicate progress. Incorporate diverse perspectives to create new solutions. Ensure work and team activities align with development quality, regulatory, HSE, GLP, and GMP requirements. Basic Requirements
Ph.D. in chemistry, biology, or a related field with 6+ years of relevant pharmaceutical experience; OR a B.S. or M.S. with 15+ years of experience. Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization; proven skills in 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. Strong communication (oral and 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 through 2025 and 2026. On-site presence required: 8-hour days, five days per week, with possible support during shutdowns, weekends, etc. 0-10% travel required. Lilly is committed to helping individuals with disabilities participate in the workforce and to providing equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for assistance. This is for accommodation requests related to the application process; other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) support and connect employees and are open to all. Current groups include Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network, Lilly India Network, Organization of Latinx at Lilly, PRIDE, Veterans Leadership Network, and Women’s Initiative for Leading at Lilly. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and geographic location. Anticipated wage range: $144,000 – $250,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program, including 401(k) eligibility, pension, vacation, health benefits, flexible spending accounts, life insurance, time off, and well-being benefits. Lilly reserves the right to amend, modify, or terminate compensation and benefit programs as needed. #WeAreLilly
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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 enable Lilly to further develop innovative solutions to optimize manufacturing processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact. In the Project Delivery Phase and Startup Phase (2025 to 2028), roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, and implement the necessary systems and business processes required to support GMP operations. This will require collaboration, creativity, and resilience as the Lilly Medicine Foundry progresses from design to start-up and steady-state operations. Role
The Analytical GMP Strategy & Compliance Director is a technical-track position that seeks a collaborative, inclusive, and energetic leader who will be accountable for providing strategic direction and leadership to ensure analytical activities within the Lilly Medicine Foundry comply with Good Manufacturing Practices (GMP). This role will partner effectively with customer groups and business partners, identify and implement best practices, resolve complex issues, and foster a laboratory GMP mindset. It will also establish and maintain a comprehensive GMP framework for analytical operations, supervise a staff of technical GMP team members, and ensure the quality and reliability of analytical data used for product development, manufacturing, and regulatory submissions. The position will promote a strong GMP culture and a safety, quality, and continuous improvement 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 ensure effective use of GMP analytical solutions; refine requirements in collaboration with SMEs and stakeholders. Represent business requirements in vendor discussions. Strategically deploy GMP analytical solutions. Demonstrate learning agility and the ability to apply scientific concepts across multiple areas (e.g., chemistry, PAT, modeling and simulation). Identify opportunities for process improvement 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; promote continued technical and professional growth, excellence, and knowledge sharing. Plan and manage short- and long-term development activities; develop and review technical agendas and timelines; allocate resources to accomplish projects and communicate progress. Incorporate diverse perspectives to create new solutions. Ensure work and team activities align with development quality, regulatory, HSE, GLP, and GMP requirements. Basic Requirements
Ph.D. in chemistry, biology, or a related field with 6+ years of relevant pharmaceutical experience; OR a B.S. or M.S. with 15+ years of experience. Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization; proven skills in 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. Strong communication (oral and 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 through 2025 and 2026. On-site presence required: 8-hour days, five days per week, with possible support during shutdowns, weekends, etc. 0-10% travel required. Lilly is committed to helping individuals with disabilities participate in the workforce and to providing equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for assistance. This is for accommodation requests related to the application process; other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) support and connect employees and are open to all. Current groups include Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network, Lilly India Network, Organization of Latinx at Lilly, PRIDE, Veterans Leadership Network, and Women’s Initiative for Leading at Lilly. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and geographic location. Anticipated wage range: $144,000 – $250,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program, including 401(k) eligibility, pension, vacation, health benefits, flexible spending accounts, life insurance, time off, and well-being benefits. Lilly reserves the right to amend, modify, or terminate compensation and benefit programs as needed. #WeAreLilly
#J-18808-Ljbffr