Senior Advisor, Process Engineering
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • United States
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Salary
💰 $129,000 - $209,000 per year
Job Level
About the role
- Lead process engineering and equipment development for complex therapies that integrate both biologics and synthetic chemistry approaches
- Apply advanced knowledge of reaction kinetics, molecular interactions, and biophysical properties to develop robust manufacturing processes
- Address unique scaling challenges through predictive modeling and mechanistic understanding of multi-modal therapeutic systems
- Connect insights from diverse disciplines to solve complex technical challenges
- Mentor and guide cross-functional teams in applying systems-thinking approaches to process development
- Lead and develop a small team of 1-3 engineers supporting kilo lab equipment development and process engineering activities
- Provide technical mentorship and guidance to team members
- Coordinate team activities and prioritize work to meet project objectives
- Foster a culture of innovation, collaboration, and continuous improvement within the team
- Serve as technical expert and advisor to development teams, operations, and senior leadership
- Active engagement and communication with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, and Manufacturing teams
- Author, review, and approve high-quality technical reports and regulatory submissions
- Develop or review project plans and timetables for equipment qualification and process validation
- Ensure that people and their environment are safe and that company policies concerning safety are followed
- Ensure processing equipment remains compliant with internal Quality System requirements, applicable engineering standards, and cGMP requirements
- Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately
- Maintain adequate records and technical notebooks in compliance with regulatory requirements
- Establish modeling and simulation as a core capability for accelerating process development and scale-up
- Develop predictive models to assess process performance, identify risks, and guide equipment specifications
- Lead equipment design, specifications, and qualification for kilo lab operations
- Perform comprehensive impact and risk assessments for critical equipment and unit operations
- Conduct heat and mass transfer analyses, computational fluid dynamics, and process simulations to ensure successful scale-up
- Challenge and redefine manufacturing paradigms that no longer fit emerging therapeutic modalities
- Integrate knowledge across chemistry, materials science, and automation to develop innovative manufacturing solutions for advanced therapeutic modalities.
Requirements
- PhD in Chemical Engineering, or related discipline and a minimum of two years of experience in pharmaceutical, biotech, or CMO environment supporting process engineering and equipment development for drug substance API manufacturing
- MS in Chemical Engineering or related discipline with minimum 10 years of relevant experience in pharmaceutical, biotech, or CMO environment supporting process engineering and equipment development for drug substance API manufacturing
- BS in Chemical Engineering or related discipline with minimum 12 years of relevant experience in pharmaceutical, biotech, or CMO environment supporting process engineering and equipment development for drug substance API manufacturing
- Proven track record of challenging and transforming manufacturing paradigms through innovative technical approaches
- Proven ability to lead, mentor, and develop technical talent at individual and team levels
- Expert-level knowledge in modeling and simulation tools (e.g., Dynochem, Aspen, COMSOL, computational fluid dynamics software)
- Deep understanding of reaction kinetics, transport phenomena, thermodynamics, and biophysical characterization
- Experience with process analytical technology (PAT) and advanced process control strategies
- Proficiency with automation systems (DeltaV), data analytics platforms (OSI-PI), and electronic lab notebooks
- Experience with complex therapeutic modalities (biologics, synthetic molecules, conjugates, oligonucleotides, peptides)
- Outstanding oral and written communication skills for diverse audiences, from operations staff to executive leadership
- Ability to work independently while maintaining strong collaborative relationships.
Benefits
- eligibility to participate in a company-sponsored 401(k)
- pension
- vacation benefits
- eligibility for medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process engineeringequipment developmentreaction kineticsmolecular interactionspredictive modelingmechanistic understandingheat and mass transfer analysescomputational fluid dynamicsprocess simulationsprocess analytical technology
Soft Skills
mentoringleadershipcollaborationcommunicationinnovationproblem-solvingteam coordinationquality mindsetsystems-thinkingtechnical guidance