Principal Scientist - Process Translation and Execution Lilly Medicine Foundry

Responsibilities:

• Facilitate transfer of chemical processes (under supervisory guidance) from development labs to pilot plant operations (kilo-scale/pilot-scale) to enable early-phase cGMP manufacturing of kilogram quantities of API for clinical trial supply.
• Operate and troubleshoot kilo-scale equipment (multi-purpose reactors, filtration systems, drying equipment incl. AFD and tray dryer).
• Apply chemical engineering principles to scale-up calculations and equipment sizing.
• Develop and apply cake filtration models; design and execute filtration wash studies.
• Model or use semi-empirical approaches to predict/control particle size distribution (PSD) during crystallization.
• Receive incoming chemical processes from R&D and evaluate safety with chemist and safety group.
• Author/review technical documentation (SOPs, batch records, campaign summary reports, deviation reports).
• Perform and document Definitive Lab Trials for crystallization step to confirm plant readiness.
• Conduct familiarization reactions focused on crystallization and filtration.
• Order and stage GMP consumables and equipment parts for kilolab runs.
• Summarize/present experimental results; analyze data for fact-based decisions.
• Maintain detailed lab notebook for technical packages/transfers.
• Drive process improvements; support troubleshooting/investigations for deviations, quality events, and non-conformances.
• Demonstrate quality mindset by proactively identifying quality issues and communicating appropriately.

Basic Requirements:

• BS or MS in Chemical Engineering or closely related discipline.
• 4+ years industry experience in pharmaceutical process development, pilot plant operations, or chemical manufacturing.
• Authorized to work in the United States full-time; Lilly does not sponsor visas.

Additional Skills/Preferences:

• Hands-on kilo/pilot-scale equipment experience; software: DeltaV, Dynochem, Aspen, and/or electronic lab notebooks.
• Crystallization experience (polymorph control, nucleation/growth kinetics, seeding strategies, PSD control).
• Filtration modeling expertise for parameter fitting and pilot sizing/optimization.
• Strong FDA/cGMP understanding; attention to detail; prioritize/manage ambiguity.
• Excellent technical communication; root-cause/problem-solving skills; cross-functional collaboration.

Other Information:

• Initial location: Parkwood West and Lilly Technology Center, Indianapolis; permanent location: Lilly Medicines Foundry, Lebanon, Indiana.
• Limited travel (<5%); manufacturing/lab environment; possible nights/weekends.

Benefits (as stated):

• Eligible for comprehensive benefits incl. 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., EAP, fitness, clubs).