Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

Role: Associate Director, Biologics Process Engineering at Lilly, leading the process engineering team to support biologics drug substance manufacturing, including monoclonal antibodies and bioconjugates, in a GMP environment. Responsibilities: establish and develop a technically advanced biologics process engineering group via recruitment, coaching, and performance management; oversee upstream (cell culture/fermentation) and downstream (chromatography, filtration, formulation) operations; ensure GMP compliance, process troubleshooting, process improvements, technology upgrades, and documentation review; serve as System Owner for critical control systems; support facility readiness during startup of Lilly Medicine Foundry (2025–2027); collaborate across teams on engineering standards, technical agenda, and regulatory interfaces. Requirements: Bachelor's in Engineering, Biochemical/Chemical Engineering or related field; 5+ years supporting biologics process development or manufacturing, preferably in GMP settings; experience with bioprocess unit operations (bioreactors, chromatography, filtration). Preferred: leadership of process engineering teams, knowledge of biologics regulatory requirements (FDA, ICH), expertise with single-use systems, biologics regulatory submissions, and process validation. High-Value: biologics (monoclonal antibodies, bioconjugates), GMP manufacturing, process development, process troubleshooting, regulatory compliance, site startup leadership, system ownership, global networking, and collaboration. Work Setup: onsite in Indianapolis or Lebanon, Indiana, with minimal travel and flexible hours.