Associate Director – Biologics Process Engineering, Lilly Medicine Foundry
Eli Lilly and Company
August 23, 2026
On-site
Lebanon, IN
Operations
Key Responsibilities:
- Establish and lead a technically advanced biologics process engineering group (recruit, supervise, coach, succession plan, performance reviews, development plans).
- Coordinate and guide process engineering work for upstream and downstream biologics unit operations (cell culture/fermentation; purification/filtration/formulation).
- Set and reinforce engineering standards and first-principles utilization; influence and implement the technical agenda and GMP Quality Plan objectives.
- Provide process engineering support for facility fit assessments, troubleshooting, scale-up/scale-down, and continuous improvements for biologic drug substance manufacturing.
- Oversee technical issues, improvement initiatives, and upgrades (bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use systems); review/approve deviations and change controls.
- Ensure GMP compliance and data integrity; maintain inspection readiness.
- Perform technical review/approval for documents (investigations, change controls, regulatory submissions, validations, manufacturing records/procedures, control strategies, technical studies, process characterization and comparability).
- Identify, track, and report functional performance indicators.
- Partner in site planning (capital/resources) for the biologics portfolio.
- Serve as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA).
- Interact with regulators and stakeholders; support BLA/IND-relevant inspections.
- Network globally to share best practices and harmonize across biologics manufacturing sites.
Startup Phase Responsibilities (2025–2027):
- Build the biologics process engineering organization and culture; develop/implement site systems and processes; support lean for regulatory compliance and operational excellence; provide biologics-specific design feedback to project team.
Basic Requirements:
- Bachelor’s degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science.
- 5+ years process engineering experience supporting biologics drug substance manufacturing/development (preferably GMP).
- Demonstrated upstream and/or downstream unit operations experience (bioreactors, chromatography, filtration, formulation).
Additional Preferences:
- Experience leading process engineers.
- Strong knowledge of bioprocess development/operations, regulatory requirements (FDA/ICH), cGMP, HSE, and data integrity for biologics.
- Single-use technology systems experience.
- Familiarity with IND/BLA/CTD submissions and process characterization/validation.
- Team collaboration, autonomy, and influence skills.
- Cell culture media/feed strategy, viral clearance, and contamination control experience (plus).
Benefits (explicitly listed):
- Company bonus; eligibility for 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits (e.g., healthcare/dependent day care FSAs); life insurance; time off/leave; well-being benefits.
Location/Work Details (explicitly listed):
- Initial: Parkwood West, Indianapolis. Permanent: Lilly Medicine Foundry, Lebanon, Indiana. Standard business hours with flexibility; minimal travel possible.
Compensation (explicitly listed):
- Anticipated wage: $123,000–$180,400.
- Establish and lead a technically advanced biologics process engineering group (recruit, supervise, coach, succession plan, performance reviews, development plans).
- Coordinate and guide process engineering work for upstream and downstream biologics unit operations (cell culture/fermentation; purification/filtration/formulation).
- Set and reinforce engineering standards and first-principles utilization; influence and implement the technical agenda and GMP Quality Plan objectives.
- Provide process engineering support for facility fit assessments, troubleshooting, scale-up/scale-down, and continuous improvements for biologic drug substance manufacturing.
- Oversee technical issues, improvement initiatives, and upgrades (bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use systems); review/approve deviations and change controls.
- Ensure GMP compliance and data integrity; maintain inspection readiness.
- Perform technical review/approval for documents (investigations, change controls, regulatory submissions, validations, manufacturing records/procedures, control strategies, technical studies, process characterization and comparability).
- Identify, track, and report functional performance indicators.
- Partner in site planning (capital/resources) for the biologics portfolio.
- Serve as System Owner for designated computer, automation, and bioprocess control systems (e.g., bioreactor SCADA).
- Interact with regulators and stakeholders; support BLA/IND-relevant inspections.
- Network globally to share best practices and harmonize across biologics manufacturing sites.
Startup Phase Responsibilities (2025–2027):
- Build the biologics process engineering organization and culture; develop/implement site systems and processes; support lean for regulatory compliance and operational excellence; provide biologics-specific design feedback to project team.
Basic Requirements:
- Bachelor’s degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science.
- 5+ years process engineering experience supporting biologics drug substance manufacturing/development (preferably GMP).
- Demonstrated upstream and/or downstream unit operations experience (bioreactors, chromatography, filtration, formulation).
Additional Preferences:
- Experience leading process engineers.
- Strong knowledge of bioprocess development/operations, regulatory requirements (FDA/ICH), cGMP, HSE, and data integrity for biologics.
- Single-use technology systems experience.
- Familiarity with IND/BLA/CTD submissions and process characterization/validation.
- Team collaboration, autonomy, and influence skills.
- Cell culture media/feed strategy, viral clearance, and contamination control experience (plus).
Benefits (explicitly listed):
- Company bonus; eligibility for 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits (e.g., healthcare/dependent day care FSAs); life insurance; time off/leave; well-being benefits.
Location/Work Details (explicitly listed):
- Initial: Parkwood West, Indianapolis. Permanent: Lilly Medicine Foundry, Lebanon, Indiana. Standard business hours with flexibility; minimal travel possible.
Compensation (explicitly listed):
- Anticipated wage: $123,000–$180,400.