Senior Director, CT Manufacturing and Materials Management

Senior / Executive Director (M3 / M3-2), CT Manufacturing and Materials Management

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.

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. It is expected that the leader applies broad functional expertise and knowledge of the supply chain as well as compliance industry practices to perform the role effectively.

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 :