Director, Process Engineering- Lilly Medicine Foundry

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

About the Lilly Medicine Foundry:

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

Organizational Overview:

Lilly is currently constructing an advanced research facility for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. 

We are seeking an experienced Advisor in Equipment Development and Process Engineering to support the kilo lab operations for complex therapies including small molecules, peptides, oligonucleotides, and bioconjugates. This position involves leading technical innovation in equipment design, developing predictive modeling capabilities, and establishing scalable manufacturing paradigms for novel therapeutic modalities.

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 Parkwood West, Indianapolis, IN

- Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana

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.

#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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