Overview

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.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 manufacturing facility in Lebanon, Indiana, dedicated to the production of new modalities for Advanced Therapies. This site will be Lilly's most technically advanced manufacturing facility, purpose built to deliver the next wave of innovative medicines. The facility will leverage next generation manufacturing technologies and advanced data collection and analytics platforms to drive step change improvements in safety, quality, and process performance. This is a unique opportunity to join the team responsible for building a state of the art facility and technical system from the ground up. The successful candidate will play a key role in the design and startup of the site, supporting both clinical and commercial supply. The TS/MS organization will own end to end responsibility for technology transfer, process validation, and ongoing process stewardship.Position Description:The TS/MS Associate Director provides technical and people leadership across Drug Substance and Drug Product processes supporting cGMP late phase and commercial manufacturing for advanced therapies. This role balances day to day production support with delivery of technical projects and process improvements, ensuring strong prioritization, execution, and team performance. Key responsibilities include leading technology transfer of new modalities to the site; developing and executing process and validation strategies; establishing and maintaining robust process control and capability; and ensuring GMP compliance across all associated documentation and activities. The role requires deep knowledge of cGMPs, gene therapy platforms, global regulatory manufacturing expectations, and industry validation standards. The Associate Director partners closely with Engineering, Operations, Quality Assurance, Quality Control, Development, Central TS/MS, and Regulatory functions to drive the site's technical agenda in a highly cross functional environment. The position also interfaces with other Lilly manufacturing sites and external contract manufacturers.Key Objectives/Deliverables:Lead and promote a strong safety culture; ensure compliance with all corporate and site Health, Safety, and Environmental (HSE) requirements.Drive performance management, coaching, and development of TSMS staff to build a high performing technical organization.Demonstrated expertise and extensive experience in gene therapy processes, technologies, cGMP commercialization, and regulatory expectations.Provide technical oversight, review, and approval of GMP documentation, including investigations, deviations, change controls, validations, regulatory submissions, annual product reviews, batch records, procedures, control strategies, and technical studies.Partner cross functionally to define and execute the site technical agenda in alignment with business objectives and the GMP Quality Plan.Serve as a technical representative in regulatory interactions, audits, and