Associate Director - Joint Process Team Lead

About the role

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 at Lilly. It 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.

Key objectives

• 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.

Basic requirements

• 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.

Additional preferences

• Ability to represent Eli Lilly and Company in a positive, professional, and ethical manner to both internal (Affiliate) and third-party contract manufacturers.
• Strong leadership and interpersonal skills, ability to build effective relationships, influence and achieve results through people.
• Self-motivated with ability to react quickly to changing requirements and processes.
• Demonstrated experience aligning with, delivery of or assuring cGMP compliance of a production operation.
• Proficiency in Word/Excel/PowerPoint and knowledge of Lilly-based systems (i.e., Trackwise, SAP, Veeva Vault).
• Project management skills including the ability to lead teams to produce quality deliverables within established time frames.
• Proficiency in Microsoft Project.
• Experience with contracts and relationships with third party suppliers.
• Establish technical, quality, and business networks.
• Travel will be required (~ 20%).

Pay

$117,000 - $171,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

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).