Principal Scientist - Process Translation and Execution Lilly Medicine Foundry

Responsibilities

In this role, the Engineer will be responsible with facilitating the transfer of chemical processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale or pilot-scale production). This enables the successful transition to early-phase cGMP manufacturing of kilogram quantities of API required for clinical trial supply.

• Operate and troubleshoot kilo-scale equipment including multi-purpose reactors, filtration systems, drying equipment (including AFD and tray dryer).

• Apply chemical engineering principles (heat/mass transfer, reaction kinetics, thermodynamics, fluid dynamics) to scale‑up calculations and equipment sizing.

• Develop and apply appropriate cake filtration models to predict filtration rate, cake resistance, and deliquoring performance. Design and execute filtration wash studies.

• Apply appropriate modeling or semi‑empirical approaches to predict and control particle size distribution (PSD) during crystallization.

• Actively involved in receiving chemical process from early phase process research and development labs and evaluating the safety of the incoming procedures in collaboration with the chemist and safety group.
  · Documentation:
  Author, review technical documents, including standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.

• Perform and document Definitive Lab Trials of crystallization step to confirm plant readiness.

• Perform familiarization reactions to ensure plant readiness of process steps with focus on crystallization and filtration at the Lilly Medicine Foundry.

• Ordering and staging process‑related GMP consumables and equipment parts for kilolab runs.

• Efficient with summarizing and presenting experimental results and challenges.

• · Analyze data to make fact‑based decisions.

• · Maintain a well‑organized and detailed lab notebook to enable the preparation of technical packages/technical transfers and accurate replication in receiving labs.

• Process improvement:
  Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.

• Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non‑conformances.

• · Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

• BS or MS in Chemical Engineering or a closely related discipline

• 4+ years of industry experience - in pharmaceutical process development, pilot plant operations, or chemical manufacturing.

• Qualified applicants mustbe authorized towork 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.

• Deep technical interest and understanding in the field of Chemical Engineering.

• Direct hands‑on experience with operating kilo‑scale or pilot‑scale chemical processing equipment.

• Experience with any of the following software packages:
  DeltaV, Dynochem, Aspen, and/or electronic lab notebooks.

• Experience with crystallization development including polymorph control, nucleation/growth kinetics, seeding strategies, and PSD control.

• Expertise on filtration modeling and ability to fit model parameters from lab data and apply to pilot equipment sizing and optimization.

• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.

• A good understanding of FDA guidelines and cGMP requirements.

• Ability to prioritize multiple activities and manage ambiguity.

• Demonstrated ability to drive projects and accept…