Associate Director – Biologics Process Engineering, Lilly Medicine Foundry
Eli Lilly and Company
18 days ago
On-site
Lebanon, IN
Operations
Key Responsibilities
- Establish and lead a technically advanced biologics process engineering group through recruitment, supervision, coaching, succession planning, performance reviews, and development planning.
- Coordinate and guide process engineering support for biologics manufacturing upstream (cell culture/fermentation) and downstream (purification, filtration, formulation).
- Set and reinforce engineering standards and first-principles utilization; influence and implement the technical agenda, site business plan, and GMP Quality Plan objectives.
- Provide process engineering support for facility fit assessments, troubleshooting, scale-up/scale-down, and continuous process improvements for biologic drug substance manufacturing.
- Oversee technical issues, improvement initiatives, and technology upgrades (e.g., bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use systems); review/approve deviations and change controls.
- Ensure GMP compliance and data integrity alignment; maintain inspection readiness.
- Provide technical review/approval for key documents (investigations, change controls, regulatory submissions, validations, records, procedures, control strategies, technical studies, process characterization/comparability).
- Identify, track, and report functional performance indicators.
- Partner in site planning (capital/resources) representing future biologics portfolio interests.
- Serve as System Owner for designated computer/automation/bioprocess control systems.
- Interact with regulators and stakeholders; support agency audits.
- Network globally to harmonize control strategies and process rationale.
Startup Phase Responsibilities (2025–2027)
- Build the biologics process engineering organization (capability, capacity, culture).
- Develop and implement site systems/processes to support GMP operations.
- Support regulatory compliance and operational excellence using 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 a team of process engineers.
- Strong understanding of bioprocess development/operations, FDA/ICH, cGMP, HSE, and data integrity.
- Single-use technology experience.
- Familiarity with IND/BLA/CTD submissions and process characterization/validation.
- Collaboration, autonomous decision-making, and influencing skills.
- Experience with cell culture media/feed strategies, viral clearance, and contamination control (plus).
Benefits (if applicable)
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, 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 planning.
- Coordinate and guide process engineering support for biologics manufacturing upstream (cell culture/fermentation) and downstream (purification, filtration, formulation).
- Set and reinforce engineering standards and first-principles utilization; influence and implement the technical agenda, site business plan, and GMP Quality Plan objectives.
- Provide process engineering support for facility fit assessments, troubleshooting, scale-up/scale-down, and continuous process improvements for biologic drug substance manufacturing.
- Oversee technical issues, improvement initiatives, and technology upgrades (e.g., bioreactors, chromatography, TFF/UF-DF, sterile filtration, single-use systems); review/approve deviations and change controls.
- Ensure GMP compliance and data integrity alignment; maintain inspection readiness.
- Provide technical review/approval for key documents (investigations, change controls, regulatory submissions, validations, records, procedures, control strategies, technical studies, process characterization/comparability).
- Identify, track, and report functional performance indicators.
- Partner in site planning (capital/resources) representing future biologics portfolio interests.
- Serve as System Owner for designated computer/automation/bioprocess control systems.
- Interact with regulators and stakeholders; support agency audits.
- Network globally to harmonize control strategies and process rationale.
Startup Phase Responsibilities (2025–2027)
- Build the biologics process engineering organization (capability, capacity, culture).
- Develop and implement site systems/processes to support GMP operations.
- Support regulatory compliance and operational excellence using 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 a team of process engineers.
- Strong understanding of bioprocess development/operations, FDA/ICH, cGMP, HSE, and data integrity.
- Single-use technology experience.
- Familiarity with IND/BLA/CTD submissions and process characterization/validation.
- Collaboration, autonomous decision-making, and influencing skills.
- Experience with cell culture media/feed strategies, viral clearance, and contamination control (plus).
Benefits (if applicable)
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, 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