Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

Role: Associate Director, Biologics Process Engineering, leading the process engineering team to support biologics drug substance manufacturing at Lilly's new Medicine Foundry. Objectives include establishing a technically advanced biologics process engineering organization, ensuring GMP compliance, and supporting startup activities. Responsibilities encompass recruiting and developing engineering talent, providing technical guidance for upstream and downstream unit operations (cell culture, chromatography, filtration), and ensuring process and facility readiness for biologics production. The role also involves technical oversight of process deviations, validation, and regulatory documentation, as well as supporting site planning and external audits. During the startup phase (2025-2027), focus shifts to building the engineering team, implementing systems and processes, and supporting operational excellence. Requirements include a Bachelor's in Engineering or related field, 5+ years supporting biologics manufacturing, with experience in upstream/downstream processes, GMP, and regulatory compliance. Preferred skills involve leadership experience, expertise with single-use systems, biologics regulatory submissions, and familiarity with cell culture strategies. High-value biopharma specifics: biologics (monoclonal antibodies, bioconjugates), GMP manufacturing, process validation, regulatory audits (FDA, ICH), and facility startup. Location is in Lebanon, Indiana, with flexible hours and minimal travel.