Associate Director – Biologics Process Engineering, Lilly Medicine Foundry
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
Operations
Key Responsibilities:
- Establish and lead a technically advanced biologics process engineering group through recruitment, supervision, coaching, succession planning, performance reviews, and development plans.
- Coordinate and provide process engineering guidance for biologics manufacturing operations (upstream: cell culture/fermentation; downstream: purification, filtration, formulation).
- Set and reinforce engineering standards and first-principles approaches; partner across engineering and functional teams to implement the technical agenda, site business priorities, and GMP Quality Plan objectives.
- Provide process engineering support for biologics operations: facility fit assessments, troubleshooting, scale-up/scale-down, and continuous process improvements.
- Oversee technical issues, improvement initiatives, and technology upgrades for unit operations (e.g., bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use systems); review/approve deviations and change controls.
- Ensure GMP compliance and inspection readiness; maintain data integrity alignment.
- Perform technical document review/approval (investigations, change controls, regulatory submissions, validations, manufacturing records, procedures, control strategies, studies, process characterization, comparability).
- Track/report functional performance indicators.
- Partner in site planning (capital/resources) for future biologics portfolio.
- Serve as System Owner for designated computer/automation/bioprocess control systems.
- Interact with regulators/stakeholders for business matters and audits.
- Network globally to harmonize best practices across sites.
Startup Phase Responsibilities (2025–2027):
- Build organization capability/capacity/culture for operational excellence.
- Develop/implement site systems and processes (leveraging Lilly practices and industry learnings).
- Support regulatory compliance and operational excellence via lean principles.
- Provide input on biologics-specific design requirements.
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 biologics unit operations experience.
Additional Preferences:
- Experience leading process engineers.
- Bioprocess development/operations and regulatory knowledge (FDA, ICH), cGMP, HSE, data integrity.
- Single-use systems experience.
- Familiarity with IND/BLA/CTD submissions and process characterization/validation.
- Collaboration, autonomy, and ability to influence diverse groups.
Benefits/Compensation:
- Anticipated wage: $123,000–$180,400; company bonus eligibility; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, and well-being benefits.
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Establish and lead a technically advanced biologics process engineering group through recruitment, supervision, coaching, succession planning, performance reviews, and development plans.
- Coordinate and provide process engineering guidance for biologics manufacturing operations (upstream: cell culture/fermentation; downstream: purification, filtration, formulation).
- Set and reinforce engineering standards and first-principles approaches; partner across engineering and functional teams to implement the technical agenda, site business priorities, and GMP Quality Plan objectives.
- Provide process engineering support for biologics operations: facility fit assessments, troubleshooting, scale-up/scale-down, and continuous process improvements.
- Oversee technical issues, improvement initiatives, and technology upgrades for unit operations (e.g., bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use systems); review/approve deviations and change controls.
- Ensure GMP compliance and inspection readiness; maintain data integrity alignment.
- Perform technical document review/approval (investigations, change controls, regulatory submissions, validations, manufacturing records, procedures, control strategies, studies, process characterization, comparability).
- Track/report functional performance indicators.
- Partner in site planning (capital/resources) for future biologics portfolio.
- Serve as System Owner for designated computer/automation/bioprocess control systems.
- Interact with regulators/stakeholders for business matters and audits.
- Network globally to harmonize best practices across sites.
Startup Phase Responsibilities (2025–2027):
- Build organization capability/capacity/culture for operational excellence.
- Develop/implement site systems and processes (leveraging Lilly practices and industry learnings).
- Support regulatory compliance and operational excellence via lean principles.
- Provide input on biologics-specific design requirements.
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 biologics unit operations experience.
Additional Preferences:
- Experience leading process engineers.
- Bioprocess development/operations and regulatory knowledge (FDA, ICH), cGMP, HSE, data integrity.
- Single-use systems experience.
- Familiarity with IND/BLA/CTD submissions and process characterization/validation.
- Collaboration, autonomy, and ability to influence diverse groups.
Benefits/Compensation:
- Anticipated wage: $123,000–$180,400; company bonus eligibility; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, and well-being benefits.
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation