Director, Process Engineering- Lilly Medicine Foundry
Eli Lilly and Company
3 months ago
On-site
Indianapolis, IN
$142,500 - $222,200 USD yearly
Operations
Responsibilities
- Lead process engineering and equipment development for complex therapies integrating biologics and synthetic chemistry.
- Apply reaction kinetics, molecular interactions, and biophysical properties to develop robust manufacturing processes.
- Address scaling challenges using predictive modeling and mechanistic understanding of multi-modal therapeutic systems.
- Connect insights across disciplines to solve complex technical challenges.
- Mentor and guide cross-functional teams using systems-thinking for process development.
- Lead and develop a small team (1–3 engineers); provide technical mentorship.
- Coordinate team activities, prioritize work, and foster innovation, collaboration, and continuous improvement.
- Serve as technical expert/advisor to development, operations, and senior leadership.
- Engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, and Manufacturing.
- Author/review/approve technical reports and regulatory submissions.
- Develop/review project plans and timetables for equipment qualification and process validation.
- Ensure safety and compliance; maintain records/technical notebooks per regulatory requirements.
- Establish modeling/simulation as a core capability; develop predictive models to assess performance, identify risks, and guide equipment specifications.
- Lead equipment design/specifications/qualification for kilo lab operations.
- Perform impact/risk assessments for critical equipment and unit operations.
- Conduct heat/mass transfer analyses, CFD, and process simulations for scale-up.
- Challenge and redefine manufacturing paradigms for emerging therapeutic modalities.
- Integrate chemistry, materials science, and automation to develop innovative manufacturing solutions.
Basic Requirements
- PhD in Chemical Engineering (or related) + 5+ years in pharmaceutical/biotech/CMO process engineering and drug substance API equipment development.
- OR MS in Chemical Engineering (or related) + 12+ years.
- OR BS in Chemical Engineering (or related) + 14+ years.
Additional Preferences (Preferred Skills)
- Track record transforming manufacturing paradigms via technical innovation.
- Proven ability to lead/mentor technical talent.
- Expert modeling/simulation tools (e.g., Dynochem, Aspen, COMSOL, CFD software).
- Deep knowledge of reaction kinetics, transport phenomena, thermodynamics, and biophysical characterization.
- Experience with PAT and advanced process control.
- Proficiency with automation (DeltaV), data analytics (OSI-PI), and electronic lab notebooks.
- Experience with complex therapeutic modalities (biologics, synthetic molecules, conjugates, oligonucleotides, peptides).
- Outstanding oral and written communication.
- Ability to work independently while maintaining strong collaboration.
Benefits
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., employee assistance program, fitness benefits).
Other Information
- Initial location: Lilly Technology Center, Indianapolis.
- Permanent location: Lilly Medicines Foundry, Lebanon, Indiana.
- Lead process engineering and equipment development for complex therapies integrating biologics and synthetic chemistry.
- Apply reaction kinetics, molecular interactions, and biophysical properties to develop robust manufacturing processes.
- Address scaling challenges using predictive modeling and mechanistic understanding of multi-modal therapeutic systems.
- Connect insights across disciplines to solve complex technical challenges.
- Mentor and guide cross-functional teams using systems-thinking for process development.
- Lead and develop a small team (1–3 engineers); provide technical mentorship.
- Coordinate team activities, prioritize work, and foster innovation, collaboration, and continuous improvement.
- Serve as technical expert/advisor to development, operations, and senior leadership.
- Engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, and Manufacturing.
- Author/review/approve technical reports and regulatory submissions.
- Develop/review project plans and timetables for equipment qualification and process validation.
- Ensure safety and compliance; maintain records/technical notebooks per regulatory requirements.
- Establish modeling/simulation as a core capability; develop predictive models to assess performance, identify risks, and guide equipment specifications.
- Lead equipment design/specifications/qualification for kilo lab operations.
- Perform impact/risk assessments for critical equipment and unit operations.
- Conduct heat/mass transfer analyses, CFD, and process simulations for scale-up.
- Challenge and redefine manufacturing paradigms for emerging therapeutic modalities.
- Integrate chemistry, materials science, and automation to develop innovative manufacturing solutions.
Basic Requirements
- PhD in Chemical Engineering (or related) + 5+ years in pharmaceutical/biotech/CMO process engineering and drug substance API equipment development.
- OR MS in Chemical Engineering (or related) + 12+ years.
- OR BS in Chemical Engineering (or related) + 14+ years.
Additional Preferences (Preferred Skills)
- Track record transforming manufacturing paradigms via technical innovation.
- Proven ability to lead/mentor technical talent.
- Expert modeling/simulation tools (e.g., Dynochem, Aspen, COMSOL, CFD software).
- Deep knowledge of reaction kinetics, transport phenomena, thermodynamics, and biophysical characterization.
- Experience with PAT and advanced process control.
- Proficiency with automation (DeltaV), data analytics (OSI-PI), and electronic lab notebooks.
- Experience with complex therapeutic modalities (biologics, synthetic molecules, conjugates, oligonucleotides, peptides).
- Outstanding oral and written communication.
- Ability to work independently while maintaining strong collaboration.
Benefits
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., employee assistance program, fitness benefits).
Other Information
- Initial location: Lilly Technology Center, Indianapolis.
- Permanent location: Lilly Medicines Foundry, Lebanon, Indiana.