Associate Director – Biologics Process Engineering, Lilly Medicine Foundry
Eli Lilly and Company
12 hours ago
On-site
Indianapolis, IN
Operations
Key Responsibilities:
- Establish and lead a technically advanced biologics process engineering group (recruitment, supervision, coaching, succession planning, development plans, performance reviews).
- Coordinate and guide biologics manufacturing operations across upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations.
- Set and reinforce engineering standards and first-principles utilization; partner to implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Provide process engineering support: facility fit assessments, troubleshooting, scale-up/scale-down, and continuous process improvements.
- Oversee biologics unit operations technology upgrades and improvement initiatives (e.g., bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use); review/approve engineering-related deviations and change controls.
- Ensure GMP compliance and inspection readiness; perform activities/documentation aligned with data integrity requirements.
- Provide technical review/approval for investigations, change controls, regulatory submissions, validations, annual product reviews, manufacturing records, procedures, process flow documents, qualification/control strategies, technical studies, and biologics documents (process characterization, comparability).
- Track/report functional performance indicators; support site capital/resource planning.
- Serve as System Owner for designated computer/automation/bioprocess control systems (e.g., bioreactor SCADA, chromatography).
- Interact with regulators/customers and support internal/external audits (BLA/IND-relevant inspections).
- Network globally to harmonize process rationale and control strategies.
Startup Phase Responsibilities (2025–2027):
- Build organization capability/capacity/culture for operational excellence.
- Develop and implement site systems and processes using Lilly practices and industry learnings.
- Support lean principles for regulatory compliance and operational excellence.
- Provide input on biologics-specific design requirements.
Basic Requirements:
- Bachelor’s degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science.
- 5+ years in process engineering supporting biologics drug substance manufacturing/development (preferably GMP).
- Demonstrated upstream and/or downstream biologics unit operations experience.
Additional Preferences:
- Experience leading a team of process engineers.
- Knowledge of bioprocess development/operations; FDA/ICH; cGMP; HSE; data integrity for biologics.
- Single-use technology systems experience.
- Familiarity with IND/BLA/CTD and process characterization/validation.
- Ability to collaborate, make autonomous decisions, and influence diverse groups.
Benefits:
- Eligibility for a company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- Submit a resume (accommodation request available via https://careers.lilly.com/us/en/workplace-accommodation if needed).
- Establish and lead a technically advanced biologics process engineering group (recruitment, supervision, coaching, succession planning, development plans, performance reviews).
- Coordinate and guide biologics manufacturing operations across upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations.
- Set and reinforce engineering standards and first-principles utilization; partner to implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Provide process engineering support: facility fit assessments, troubleshooting, scale-up/scale-down, and continuous process improvements.
- Oversee biologics unit operations technology upgrades and improvement initiatives (e.g., bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use); review/approve engineering-related deviations and change controls.
- Ensure GMP compliance and inspection readiness; perform activities/documentation aligned with data integrity requirements.
- Provide technical review/approval for investigations, change controls, regulatory submissions, validations, annual product reviews, manufacturing records, procedures, process flow documents, qualification/control strategies, technical studies, and biologics documents (process characterization, comparability).
- Track/report functional performance indicators; support site capital/resource planning.
- Serve as System Owner for designated computer/automation/bioprocess control systems (e.g., bioreactor SCADA, chromatography).
- Interact with regulators/customers and support internal/external audits (BLA/IND-relevant inspections).
- Network globally to harmonize process rationale and control strategies.
Startup Phase Responsibilities (2025–2027):
- Build organization capability/capacity/culture for operational excellence.
- Develop and implement site systems and processes using Lilly practices and industry learnings.
- Support lean principles for regulatory compliance and operational excellence.
- Provide input on biologics-specific design requirements.
Basic Requirements:
- Bachelor’s degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science.
- 5+ years in process engineering supporting biologics drug substance manufacturing/development (preferably GMP).
- Demonstrated upstream and/or downstream biologics unit operations experience.
Additional Preferences:
- Experience leading a team of process engineers.
- Knowledge of bioprocess development/operations; FDA/ICH; cGMP; HSE; data integrity for biologics.
- Single-use technology systems experience.
- Familiarity with IND/BLA/CTD and process characterization/validation.
- Ability to collaborate, make autonomous decisions, and influence diverse groups.
Benefits:
- Eligibility for a company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- Submit a resume (accommodation request available via https://careers.lilly.com/us/en/workplace-accommodation if needed).