Associate Director - Joint Process Team Lead

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 is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products  will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance.

This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up. The LP2-EM Joint Process Team Leader is focused on relationship building internally and externally, leading the cross functional team and project prioritization and management for assigned relationships within Lebanon 2 External Manufacturing (LP2-ExM).

• Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM), to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the CM.
• Successfully facilitate and champion quality, technical, and regulatory compliance to ensure continuous supply to the marketplace.
• Manage production, batch release and shipment schedules to ensure appropriate resources to meet objectives.
• Resolve supply chain issues and provide internal notification to management or joint Lilly/CM Steering Team as necessary.
• Accountable for the metrics that align with Global Contract Manufacturing Standards (GCMS) to monitor performance at the CMs, and to review these at API external manufacturing lead team meetings.
• Serve as liaison to communicate status and issues to various management levels in operations, quality, marketing, and manufacturing networks.
• Author Manufacturing Responsibilities Document (MRD) defining each party’s roles and responsibilities aligned with the contract and Quality Agreement.
• Ensure that the MRD and contracts are being adhered to by Lilly and the CM.
• Make regular visits to CM to increase awareness of operations and maintain a strong working relationship.
• Manage conflict and problem resolution.
• Facilitate Lilly/CM Steering Team meeting agendas with issues from the JPT meetings requiring Steering Team action. Present and document the decisions in Steering Team minutes.
• Meet regularly with customers (Lilly plant sites or Lilly affiliates) to ensure supply goals are met, review performance metrics and improve customer service.
• Evaluate and manage efficiencies with product supply chains. Work with Tech Service/QC/Engineering/QA Representatives and 6 Sigma on continuous improvement projects.
• Accountable for on time delivery of commitments to supply plan, quality plan, and technical agenda.
• Deliver all product / projects to comply with GQS, GCMS, and applicable internal SOP’s.
• Other tasks may include assisting Tech Service and QA personnel to ensure timely completion of APR, AR, MR as necessary.

• Bachelor’s degree or equivalent in Chemical Engineering, Mechanical Engineering, Chemistry/Biochemistry or related science.
• 5+ years of experience in pharmaceutical manufacturing, technical support, quality assurance, and/or quality engineering.

• Ability to represent Eli Lilly and Company in a positive, professional, and ethical manner to both internal (Affiliate) and third-party contract manufacturers.
• Strong…