Eli Lilly and Company
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundr...
Eli Lilly and Company - Lebanon, Indiana, United States, 46052
Work at Eli Lilly and Company
Overview
- View job
Overview
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
Join to apply for the
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
role at
Eli Lilly and Company Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
4 days ago Be among the first 25 applicants Join to apply for the
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
role at
Eli Lilly and Company 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). 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any 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) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$144,000 - $250,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Finance and Sales Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Eli Lilly and Company by 2x Sign in to set job alerts for “Compliance Lead” roles.
Manager, Regulatory Affairs - Hybrid - 134458
Vice President, Head of Regulatory Legal
Indiana, United States $247,500.00-$363,000.00 1 week ago Long-Term Recovery Grant Program and Compliance Specialist
Indiana, United States $74,200.00-$79,120.00 10 hours ago Corporate Denials and Appeals Specialist
SBA Post-Closing Compliance Specialist I
Vice President of Operational Excellence
Carmel, IN $93,000.00-$110,000.00 4 days ago Fishers, IN $100,000.00-$125,000.00 2 weeks ago Vice President, Head of Regulatory Legal
Indiana, United States $247,500.00-$363,000.00 2 weeks ago Indiana, United States $75,000.00-$90,000.00 2 weeks ago Noblesville, IN $100,000.00-$120,000.00 2 months ago Fishers, IN $90,000.00-$100,000.00 1 week ago Garfield, IN $90,000.00-$130,000.00 1 day ago Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
Lebanon, IN $144,000.00-$250,800.00 1 day ago Export Compliance Specialist (10814-2025233)
Indiana, United States $47,000.00-$67,000.00 2 days ago Indiana, United States $117,600.00-$161,700.00 2 weeks ago Indiana, United States $43.00-$48.70 1 week ago Cyber Senior Manager – Privileged Access Management
Indiana, United States $133,500.00-$302,400.00 22 hours ago Senior Patient Recruitment and Engagement Lead
Indiana, United States $75,000.00-$126,000.00 4 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Join to apply for the
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
role at
Eli Lilly and Company Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
4 days ago Be among the first 25 applicants Join to apply for the
Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
role at
Eli Lilly and Company 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). 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any 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) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$144,000 - $250,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Finance and Sales Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Eli Lilly and Company by 2x Sign in to set job alerts for “Compliance Lead” roles.
Manager, Regulatory Affairs - Hybrid - 134458
Vice President, Head of Regulatory Legal
Indiana, United States $247,500.00-$363,000.00 1 week ago Long-Term Recovery Grant Program and Compliance Specialist
Indiana, United States $74,200.00-$79,120.00 10 hours ago Corporate Denials and Appeals Specialist
SBA Post-Closing Compliance Specialist I
Vice President of Operational Excellence
Carmel, IN $93,000.00-$110,000.00 4 days ago Fishers, IN $100,000.00-$125,000.00 2 weeks ago Vice President, Head of Regulatory Legal
Indiana, United States $247,500.00-$363,000.00 2 weeks ago Indiana, United States $75,000.00-$90,000.00 2 weeks ago Noblesville, IN $100,000.00-$120,000.00 2 months ago Fishers, IN $90,000.00-$100,000.00 1 week ago Garfield, IN $90,000.00-$130,000.00 1 day ago Analytical GMP Strategy & Compliance Leader Lilly Medicine Foundry
Lebanon, IN $144,000.00-$250,800.00 1 day ago Export Compliance Specialist (10814-2025233)
Indiana, United States $47,000.00-$67,000.00 2 days ago Indiana, United States $117,600.00-$161,700.00 2 weeks ago Indiana, United States $43.00-$48.70 1 week ago Cyber Senior Manager – Privileged Access Management
Indiana, United States $133,500.00-$302,400.00 22 hours ago Senior Patient Recruitment and Engagement Lead
Indiana, United States $75,000.00-$126,000.00 4 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr