
Director, Process Engineering- Lilly Medicine Foundry
BioSpace, lebanon, remote, United States
Position Summary
The Senior Advisor/Director for Kilo Lab Equipment Development & Process Engineering serves as a technical leader responsible for driving innovation in equipment design, rapid prototyping, and scale‑up strategies for complex therapeutic manufacturing. This role includes leadership of a small team of 1 to 3 engineers and requires mastery of first principles chemical engineering to develop novel equipment solutions and manufacturing processes. The successful candidate will apply fundamental principles of heat and mass transfer, reaction kinetics, thermodynamics, and transport phenomena to design, prototype, and qualify equipment for complex therapies that integrate biologics and synthetic chemistry. Through rapid prototyping methodologies and predictive modeling, this leader will accelerate equipment development cycles, challenge existing manufacturing paradigms, and establish scalable processes that enable breakthrough therapies to reach patients faster.
Responsibilities
Complex Therapy Development
- 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
Modeling & Simulation Leadership
- Connect insights from diverse disciplines to solve complex technical challenges
- Mentor and guide cross‑functional teams in applying systems‑thinking approaches to process development
Team Leadership
- 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
Technical Leadership & Collaboration
- 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
Quality & Compliance
- 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
Equipment Development & Scale‑Up
- 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
Cross‑Disciplinary Innovation
- Integrate knowledge across chemistry, materials science, and automation to develop innovative manufacturing solutions for advanced therapeutic modalities
Basic Requirements
- PhD in Chemical Engineering, or related discipline and a minimum of five 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 12 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 14 years of relevant experience in pharmaceutical, biotech, or CMO environment supporting process engineering and equipment development for drug substance API manufacturing
Additional Preferences
- 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
Other Information
- Initial location at Lilly Technology Center, Indianapolis
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 – $222,200 .
Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k), pension, vacation benefits, 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, and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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