Associate Director – Biologics Process Engineering, Lilly Medicine Foundry

Lilly • Indianapolis, IN

1d • $123,000 - $180,400

About The Position

The Associate Director, Biologics Process Engineering provides leadership and direction to the process engineering team, ensuring engineering deliverables are properly resourced and qualified to support biologics drug substance manufacturing and business priorities. The role develops process engineers and ensures reliable, compliant equipment and systems are used to manufacture biologic products, including monoclonal antibodies, bioconjugates, and other large-molecule modalities. The team leader also influences cross-functional work in support of process engineering, business plan, and compliance objectives.

The position is initially based at Parkwood West in Indianapolis, with a permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. During the Foundry’s project delivery and startup phase, expected from 2025 to 2027, leadership responsibilities will evolve as the site is delivered, a new organization is built, and systems, business processes, and site culture are established for GMP clinical-trial operations. This requires collaboration, creativity, and resilience. The role has standard business hours, with flexibility to support startup, shutdowns, and weekends as required. Travel is possible but expected to be minimal.

Requirements

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

Nice To Haves

• Experience leading a team of process engineers.
• Thorough understanding of bioprocess development and operations, FDA and ICH regulatory requirements, cGMP, HSE regulations, and data-integrity requirements as they apply to biologics manufacturing.
• Experience with single-use technology systems and related engineering considerations.
• Familiarity with biologics regulatory submissions, including IND, BLA, and CTD modules, and with process characterization and validation requirements.
• Ability to collaborate effectively, make autonomous decisions, and influence diverse groups.
• Ability to foster teamwork and demonstrate strong interpersonal skills.
• Ability to develop creative solutions to plant, divisional, and corporate issues using insights from multiple functional areas.
• Experience with cell culture media and feed strategies, viral clearance requirements, and biologics-specific contamination control strategies.

Responsibilities

• Establish a technically advanced biologics process engineering group through recruitment, supervision, coaching, succession planning, performance reviews, and actionable development plans.
• Coordinate and guide process engineering work for functional groups and partners supporting upstream and downstream biologics manufacturing operations.
• Set and reinforce engineering work-product standards and the use of first principles; partner across Engineering and other functions to advance technical, business-plan, and GMP Quality Plan objectives.
• Ensure process engineering support for biologics operations, including facility-fit assessments, troubleshooting, scale-up and scale-down, and continuous process improvement.
• Oversee technical issues, improvement initiatives, and technology upgrades for biologics unit operations, and review and approve engineering-related deviations and change controls.
• Maintain GMP compliance of facilities, processes, and documentation, keep the organization inspection-ready, and ensure alignment with current data-integrity requirements.
• Technically review and approve appropriate documents, including investigations, change controls, regulatory submissions, validations, manufacturing records, procedures, control strategies, technical studies, process characterization reports, and comparability assessments.
• Identify, track, and report key indicators of functional performance.
• Represent the team in site capital and resource planning, considering overall site priorities and the future biologics portfolio.
• Serve as System Owner for designated computer, automation, and bioprocess control systems.
• Interact with regulators, customers, and other external stakeholders on business matters and in support of internal and external agency audits, including BLA/IND-relevant inspections.
• Share best practices, control strategies, and process rationale globally to promote harmonization across Lilly biologics manufacturing sites.
• During the Foundry startup phase, build the biologics process engineering organization’s capability, capacity, and culture.
• Develop and implement site systems and processes, drawing on Lilly biologics practices and external biopharmaceutical industry experience.
• Support regulatory compliance and operational excellence, including lean principles.
• Provide biologics-specific design feedback and input to the project team as the facility is delivered to the site team.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director