Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

Associate Director, Biologics Process Engineering

Position based in Indianapolis (initially Parkwood West, then the new Lilly Medicine Foundry in Lebanon, Indiana). Standard business hours with flexibility for startup, shutdowns, and weekend activities.

• Establish a technically advanced biologics process engineering group through recruitment, supervision, coaching, succession planning, and development planning.
• Coordinate and guide process engineering work for key functional groups and partners supporting biologics manufacturing operations, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations.
• Set and reinforce standards for engineering work product and utilization of first principles, partnering across teams to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Provide process engineering support for biologics operations, including facility fit assessments, process troubleshooting, scale‑up/scale‑down support, and continuous process improvements for biologic drug substance manufacturing.
• Oversee engineering‑related technical issues, improvement initiatives, and technology upgrades specific to biologics unit operations (e.g., bioreactors, chromatography systems, TFF/UF‑DF, sterile filtration, single‑use systems); review and approve engineering‑related deviations and change controls.
• Ensure GMP compliance of facilities, processes, and documentation, maintaining inspection readiness and data integrity requirements.
• Approve technical documents such as investigations, change controls, regulatory submissions, validations, annual product reviews, manufacturing records, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, and biologics‑specific documents (e.g., process characterization reports, comparability assessments).
• Track and report key indicators of functional performance.
• Partner in site planning processes (capital and resource) representing the team's interests in the overall site picture and future biologics portfolio.
• Act as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA, chromatography systems).
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of audits and inspections.
• Network globally to share best practices, control strategies, and process rationale for harmonization across Lilly biologics manufacturing sites.

• Build the biologics process engineering organization with the necessary capability, capacity, and culture.
• Develop and implement the systems and processes needed to run the site, leveraging Lilly's existing knowledge and external industry best practices.
• Ensure regulatory compliance and operational excellence through lean principles.
• Support the project team by providing feedback on biologics‑specific design requirements.

• Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, or a related science field.
• At least 5 years of experience in a process engineering role supporting biologics drug substance manufacturing or development, preferably in a GMP environment.
• Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, chromatography, filtration, formulation).

• Experience leading a team of process engineers.
• Thorough understanding of bioprocess development and operations, regulatory requirements (FDA, ICH), cGMP, HSE regulations, and data integrity requirements.
• Experience with single‑use technology systems and associated engineering considerations.
• Familiarity with biologics regulatory submissions (IND, BLA, CTD modules) and process characterization/validation requirements.
• Ability to collaborate effectively within teams, make autonomous decisions, and influence diverse groups.
• Proficiency in fostering teamwork and showcasing interpersonal skills.
• Creative problem‑solving across plant, divisional, and corporate issues.
• Knowledge of cell culture media/feed…