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 a Process Engineer to support the pilot plant facility in Lebanon, with a focus on small molecule Kilo Lab and High Potency Lab operations. This position involves solving technical challenges with kilo-scale reactor and scale-up equipment design, developing and sustaining process knowledge for both standard and high-potency (HPAPI) chemistries, optimizing processes across synthesis, crystallization, distillation, and isolation unit operations, and managing equipment capabilities and containment strategies for the Kilo Lab and High Potency Lab suites.
Responsibilities
The Process Engineer provides technical assessment and support for production operations in the areas of developing and sustaining process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems. This role is to serve as a process engineer supporting drug substance active pharmaceutical ingredient (API) manufacturing within the Kilo Lab and High Potency Lab.
Evaluate scale-up feasibility and rig fit for new chemistries by analyzing technical data packages and running kinetic, mass-transfer, and heat-transfer modeling and experiments to ensure clean transfer from gram- to kilogram-scale reactors.
Design, test and install new equipment to meet the evolving portfolio and reaction needs.
Design, operate, and troubleshoot kilo-scale reactor systems — glass-lined and Hastelloy reactors, agitated filter-dryers — partnering with Kilo Lab and High Potency Lab chemists and shaping plant design for piping, mixing, heat transfer, and automation.
Engineer containment and safe-handling strategies for HPAPI operations, spanning isolator and glove-box systems, occupational exposure banding (OEB), and dry-end solids processing.
Optimize crystallization, distillation, extraction, and isolation unit operations, resolving polymorphism and particle-size challenges while closing mass balances and tracking impurity fate and purge across multi-step syntheses.
Safeguard quality, safety, and cGMP compliance across equipment and procedures, and author or review technical reports, regulatory submissions, and lab notebooks to a high standard.
Drive cross-functional execution by conducting impact and risk assessments, coordinating with HSE, QA, Tech Services, Development, Operations, Automation, and Manufacturing, and developing project plans and timetables with a proactive quality mindset.
Develop or review plans and timetables for project work.
Basic Requirements
BS or MS in chemical engineering or related discipline and a minimum of 1-4 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of drug substance active pharmaceutical ingredient (API) manufacturing or development.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences
Deep technical interest and understanding in the field of process development and chemical engineering
Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability
Experience with any of the following software packages: DeltaV, Dynochem, Aspen, and/or electronic lab notebooks
Experience with kilo-scale equipment (e.g., glass-lined/Hastelloy reactors, agitated filter-dryers) and understanding of scale-up factors including kinetics, mass transfer, and heat transfer
Familiarity with high-potency API (HPAPI) handling, containment equipment (isolators, glove boxes), and occupational exposure banding (OEB) practices
Working knowledge of key organic chemistry unit operations (crystallization, distillation, extraction) and analytical techniques (HPLC/UPLC, MS, NMR, GC, KF, DSC, XRD) Experience supporting small molecule process chemistry scale-up from gram to kilogram scale in a cGMP environment
Working knowledge of bioconjugate unit operations including single use, TFF and chromatography.
Strong analytical and problem-solving skills
Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.
Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals
Understanding of process control systems
Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented
Guidance/mentoring of others through processes
Flexibility to meet business needs
Other Information
Initial location at Parkwood West, Indianapolis.
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.
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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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
- Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
- $67,500 - $173,800
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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