BioSpace
Senior Director, CT Manufacturing and Materials Management
BioSpace, Indianapolis, Indiana, us, 46262
Position Title
Senior/Executive Director (M3/M3-2), CT Manufacturing and Materials Management
Reporting to
Associate Vice President (M4), Clinical Material Delivery
Organization Overview
Clinical Supply and Delivery (CSD) organization is accountable for delivering the right drug to the right patient at the right time, every time. This ever‑evolving global organization delivers clinical trial (CT) materials with the technical expertise, speed and agility required for the rapidly growing portfolio by ensuring capacity, capability and optimal flexibility. Within the CSD, Clinical Material Delivery is responsible for CMC Materials Management/Dispensing/Warehousing, CT drug product manufacturing, labeling, packaging, and CT global distribution/logistics functions. The CT manufacturing organization consists of three major components: Materials Management, CT Operations and CT Manufacturing Oversight. CT manufacturing is accomplished either externally at approved Third Party Contract Manufacturing sites or internally at Lilly manufacturing facilities. The Senior/Executive Director is accountable for the development, oversight and management of the pan‑R&D business systems for the management of raw material (both for Drug Substance and Drug Product), Drug Substance supply chains after DS manufacture, and materials management services. The Sr. Director provides leadership and oversight to challenge work paradigms and promote continuous improvement while ensuring GxP compliance, technical excellence and operational excellence.
Responsibilities
CT Site Sourcing and Materials Management:
Clinical Material Delivery applies a significant network of external partners and vendors that must be effectively handled to ensure reliable production and delivery across the supply chain. The CT manufacturing team is responsible for the execution of the site source evaluation process and ultimate site sourcing recommendation. Portfolio Programs can require site sourcing support at many points throughout the lifecycle. This process requires close partnership with Clinical Supply, CMC PM, SMDD, BRD, B358 Manufacturing, DDCS, Procurement and PRD Quality Assurance with additional partnership with Lilly commercial manufacturing for late Phase assets. The leader in this role will: Supervise and develop the overall supply network, with deep understanding of the capabilities of both internal and external partners. Help gather information and set strategy for site selection process working in close partnership with QA and the partners listed above. Gain leadership alignment on final selection. Interface regularly with external business partners through formal and informal meetings to actively handle relationships to ensure an effective and compliant working environment. Accountable for parts of Materials Management across the CT supply chain, including but not limited to sourcing, management and operational oversight for the raw materials and components applied in CMC development and clinical trial material production.
Operational Excellence, Quality Assurance and Safety:
Clinical Material Delivery is committed to Safety First, Quality Always and Operational Excellence; many activities and forums are established with this structure and philosophy. As such, the Sr./Executive Director will engage at a strategy level to ensure quality, continuous improvement and efficiency to meet the ever‑increasing clinical demands. Lead the establishment of an effective metrics strategy including metrics which span the deliverables of multiple departments to provide a more holistic understanding of effectiveness. Identify continuous improvement opportunities across the organization, drive improvement efforts. Ensure deviations are addressed and a corrective and preventative action programs supported. Accountable for staffing strategy to meet current and future needs of CT Manufacturing and Materials by understanding and anticipating required future skills. Build an environment that fosters and encourages cooperation, mutual respect, diversity, inclusion, thoughtful and informed decision making.
Strategic and Business Planning while Driving Alignment with Functional Area Partners:
In support of the portfolio, Clinical Material Delivery works closely with Senior Leadership and the partners listed previously including CSD functions to develop and improve clinical material delivery strategy. The includes the development of the business and strategic plans for Clinical Material Delivery. Partner with CSD and PRD Leadership to ensure alignment into broader objectives and initiatives when the roadmap for the CT Manufacturing and Materials organization. Build strong partnership with drug development partners. Partner with and lead integration activities on behalf of CT manufacturing and materials for third party business partnerships. Facilitate routine communications to optimize material delivery, align priorities, determine technical or program requirements, and issue resolution as needed. Partner with Finance and Capital Planning to support leadership in establishing business plan expense targets, tracking and monitoring business plans and fixed/variable financial budgets.
Basic Qualifications
Bachelor’s degree in a technical discipline (e.g., engineering, biology, chemistry, pharmaceutical sciences) or supply chain
Basic Requirements
8+ years of relevant professional experience - Clinical Manufacturing, Supply Chain, CMC, Commercial Manufacturing.
4+ years’ experience in people management
Additional Skills and Preferences
Experience with Operational Excellence principles
Experience leading improvement initiatives, process minded with improvement mindset
Strong problem‑solving skills are essential
Relevant professional licenses or certifications (e.g., APICS, Supply Chain Certificate, Project Management, Six Sigma, Lean)
Experience operating in a regulated environment
Demonstrated critical thinking, strategy development, and decision‑making skills
Excellent oral and written communication skills and the ability to communicate clearly with peers and leadership
Excellent self‑management and organizational skills are required. Must be able to handle working with many different teams with varying styles, issues, and complexity and to independently handle workload and adjust priorities as needed
Experience leading cross‑functional teams
Demonstrated organizational change management leadership
Demonstrated understanding of business principles with the ability to maintain a portfolio view of the work
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. 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.
Location Indianapolis, IN
Equal Opportunity Statement 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.
#WeAreLilly Lilly is dedicated to building a future for people facing the challenges of disease. We work together to lead the next generation of medicines.
#J-18808-Ljbffr
Senior/Executive Director (M3/M3-2), CT Manufacturing and Materials Management
Reporting to
Associate Vice President (M4), Clinical Material Delivery
Organization Overview
Clinical Supply and Delivery (CSD) organization is accountable for delivering the right drug to the right patient at the right time, every time. This ever‑evolving global organization delivers clinical trial (CT) materials with the technical expertise, speed and agility required for the rapidly growing portfolio by ensuring capacity, capability and optimal flexibility. Within the CSD, Clinical Material Delivery is responsible for CMC Materials Management/Dispensing/Warehousing, CT drug product manufacturing, labeling, packaging, and CT global distribution/logistics functions. The CT manufacturing organization consists of three major components: Materials Management, CT Operations and CT Manufacturing Oversight. CT manufacturing is accomplished either externally at approved Third Party Contract Manufacturing sites or internally at Lilly manufacturing facilities. The Senior/Executive Director is accountable for the development, oversight and management of the pan‑R&D business systems for the management of raw material (both for Drug Substance and Drug Product), Drug Substance supply chains after DS manufacture, and materials management services. The Sr. Director provides leadership and oversight to challenge work paradigms and promote continuous improvement while ensuring GxP compliance, technical excellence and operational excellence.
Responsibilities
CT Site Sourcing and Materials Management:
Clinical Material Delivery applies a significant network of external partners and vendors that must be effectively handled to ensure reliable production and delivery across the supply chain. The CT manufacturing team is responsible for the execution of the site source evaluation process and ultimate site sourcing recommendation. Portfolio Programs can require site sourcing support at many points throughout the lifecycle. This process requires close partnership with Clinical Supply, CMC PM, SMDD, BRD, B358 Manufacturing, DDCS, Procurement and PRD Quality Assurance with additional partnership with Lilly commercial manufacturing for late Phase assets. The leader in this role will: Supervise and develop the overall supply network, with deep understanding of the capabilities of both internal and external partners. Help gather information and set strategy for site selection process working in close partnership with QA and the partners listed above. Gain leadership alignment on final selection. Interface regularly with external business partners through formal and informal meetings to actively handle relationships to ensure an effective and compliant working environment. Accountable for parts of Materials Management across the CT supply chain, including but not limited to sourcing, management and operational oversight for the raw materials and components applied in CMC development and clinical trial material production.
Operational Excellence, Quality Assurance and Safety:
Clinical Material Delivery is committed to Safety First, Quality Always and Operational Excellence; many activities and forums are established with this structure and philosophy. As such, the Sr./Executive Director will engage at a strategy level to ensure quality, continuous improvement and efficiency to meet the ever‑increasing clinical demands. Lead the establishment of an effective metrics strategy including metrics which span the deliverables of multiple departments to provide a more holistic understanding of effectiveness. Identify continuous improvement opportunities across the organization, drive improvement efforts. Ensure deviations are addressed and a corrective and preventative action programs supported. Accountable for staffing strategy to meet current and future needs of CT Manufacturing and Materials by understanding and anticipating required future skills. Build an environment that fosters and encourages cooperation, mutual respect, diversity, inclusion, thoughtful and informed decision making.
Strategic and Business Planning while Driving Alignment with Functional Area Partners:
In support of the portfolio, Clinical Material Delivery works closely with Senior Leadership and the partners listed previously including CSD functions to develop and improve clinical material delivery strategy. The includes the development of the business and strategic plans for Clinical Material Delivery. Partner with CSD and PRD Leadership to ensure alignment into broader objectives and initiatives when the roadmap for the CT Manufacturing and Materials organization. Build strong partnership with drug development partners. Partner with and lead integration activities on behalf of CT manufacturing and materials for third party business partnerships. Facilitate routine communications to optimize material delivery, align priorities, determine technical or program requirements, and issue resolution as needed. Partner with Finance and Capital Planning to support leadership in establishing business plan expense targets, tracking and monitoring business plans and fixed/variable financial budgets.
Basic Qualifications
Bachelor’s degree in a technical discipline (e.g., engineering, biology, chemistry, pharmaceutical sciences) or supply chain
Basic Requirements
8+ years of relevant professional experience - Clinical Manufacturing, Supply Chain, CMC, Commercial Manufacturing.
4+ years’ experience in people management
Additional Skills and Preferences
Experience with Operational Excellence principles
Experience leading improvement initiatives, process minded with improvement mindset
Strong problem‑solving skills are essential
Relevant professional licenses or certifications (e.g., APICS, Supply Chain Certificate, Project Management, Six Sigma, Lean)
Experience operating in a regulated environment
Demonstrated critical thinking, strategy development, and decision‑making skills
Excellent oral and written communication skills and the ability to communicate clearly with peers and leadership
Excellent self‑management and organizational skills are required. Must be able to handle working with many different teams with varying styles, issues, and complexity and to independently handle workload and adjust priorities as needed
Experience leading cross‑functional teams
Demonstrated organizational change management leadership
Demonstrated understanding of business principles with the ability to maintain a portfolio view of the work
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. 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.
Location Indianapolis, IN
Equal Opportunity Statement 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.
#WeAreLilly Lilly is dedicated to building a future for people facing the challenges of disease. We work together to lead the next generation of medicines.
#J-18808-Ljbffr