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 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.
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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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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