Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. 

The Associate Director, Biologics Process Engineering provides leadership and direction to the process engineering team to ensure that engineering deliverables are sufficiently resourced and qualified to support biologics drug substance manufacturing and the broader business agenda. This role is responsible for the productivity and development of process engineers with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacture of biologic products, including monoclonal antibodies, bioconjugates, and other large molecule modalities. 

The Biologics Process Engineering Team Leader leads the process engineering organization and influences across functional teams to support the process engineering agenda, business plan priorities, and compliance plan objectives. 

In the project delivery and startup phase of the Lilly Medicine Foundry (startup expected 2025 to 2027), leadership roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site evolves from a design concept to a GMP clinical trial site. 

Key Responsibilities 

• Responsible for establishing a technically advanced biologics process engineering group. This is achieved through recruitment, supervision, coaching, succession planning, and establishing actionable development plans, inclusive of completing performance reviews and development planning. 

• Provide process engineering work coordination and guidance to key functional groups and partners supporting biologics manufacturing operations, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations. 

• In coordination with the engineering function, set and reinforce standards for engineering work product and utilization of first principles. Partner within Engineering and across functional teams to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives. 

• Ensure appropriate 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 the organization in a state of inspection readiness. Ensure all process engineering activities and documentation are performed in alignment with current data integrity requirements. 

• Ensure technical review and approval for documents as appropriate, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing records, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, and biologics-specific documents such as process characterization reports and comparability assessments. 

• Identify, track, and report key indicators of functional performance. 

• Partner appropriately in site planning processes (capital and resource), representing the interests of the team with a view to the overall site picture and future biologics portfolio. 

• Serves as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA, process chromatography systems). 

• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits, including BLA/IND-relevant inspections. 

• Network globally to share best practices, control strategies, and process rationale to ensure harmonization and alignment between Lilly biologics manufacturing sites. 

Startup Phase Responsibilities (2025–2027) 

During the startup phase of the Lilly Medicine Foundry, leadership will be expected to be collaborative, inclusive, and support the broader team to: 

• Build the biologics process engineering organization with the necessary capability, capacity, and culture to operate this facility to the highest standards of operational excellence. 

• Develop and implement the systems and processes needed to run the site, leveraging existing Lilly biologics knowledge and practices where applicable, while also incorporating external experiences and learnings from the broader biopharmaceutical industry. 

• Ensure regulatory compliance and operational excellence by supporting lean principles in their respective area. 

• Support the project team as they deliver the facility to the site team by providing feedback and input on biologics-specific design requirements. 

Basic Requirements 

• Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, or a related science field. 

• 5+ years of experience in a process engineering role supporting biologics drug substance manufacturing or development activities, preferably in a GMP manufacturing environment. 

• Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, chromatography, filtration, formulation). 

Additional Preferences 

• Experience leading a team of process engineers highly preferred 

• Thorough understanding of bioprocess development and operations, regulatory requirements (FDA, ICH), cGMP, HSE regulations, and data integrity requirements as they apply to biologics manufacturing. 

• Experience with single-use technology systems and associated engineering considerations. 

• Familiarity with biologics regulatory submissions (IND, BLA, CTD modules) and process characterization/validation requirements. 

• Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups. 

• Skilled at fostering teamwork within the department and showcasing essential interpersonal skills. 

• Proficient in devising creative solutions to plant, divisional, and corporate issues, while leveraging insights from various functional areas. 

• Experience with cell culture media/feed strategies, viral clearance requirements, and biologics-specific contamination control strategies is a plus. 

Other Information 

• Initial location at Parkwood West, Indianapolis. 

• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana. 

• Position is standard business hours with flexibility to support activities during startup, shutdowns, and weekends as required. 

• Travel is possible but expected to be minimal. 

• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly