Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

About the role

The Associate Director, Biologics Process Engineering at Lilly is responsible for leading a team of process engineers to support the manufacturing of biologics, including monoclonal antibodies, bioconjugates, and other large molecule modalities. This role involves setting and reinforcing standards for engineering work product, influencing and implementing the technical agenda, and ensuring GMP compliance.

Responsibilities

• Establish a technically advanced biologics process engineering group through recruitment, supervision, coaching, succession planning, and development plans.
• Provide process engineering work coordination and guidance to key functional groups and partners supporting biologics manufacturing operations.
• 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.
• Oversee engineering-related technical issues, improvement initiatives, and technology upgrades specific to biologics unit operations.
• 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.
• Identify, track, and report key indicators of functional performance.
• Partner appropriately in site planning processes, representing the interests of the team with a view to the overall site picture and future biologics portfolio.
• Serve as System Owner for designated computer, automation, and bioprocess control systems.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Network globally to share best practices, control strategies, and process rationale to ensure harmonization and alignment between Lilly biologics manufacturing sites.

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.