Principal Scientist - Process Translation and Execution Lilly Medicine Foundry
Eli Lilly and Company
9 days ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Facilitate transfer of chemical processes (with appropriate supervisory guidance) from development labs to pilot plant operations (kilo-scale or pilot-scale) for 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 (AFD, tray dryer).
- Apply chemical engineering principles (heat/mass transfer, reaction kinetics, thermodynamics, fluid dynamics) for scale-up calculations and equipment sizing.
- Develop/apply cake filtration models; design and execute filtration wash studies.
- Model/semi-empirically predict and control particle size distribution (PSD) during crystallization.
- Receive process from early-phase R&D labs and evaluate incoming procedure safety with chemist and safety group.
- Author/review technical documents (SOPs, batch records, campaign summary reports, deviation reports).
- Perform and document definitive lab trials of crystallization steps; run familiarization reactions (focus on crystallization and filtration).
- Order/stage GMP consumables and equipment parts for kilolab runs.
- Summarize/present experimental results; analyze data for fact-based decisions; maintain detailed lab notebooks.
- Drive process improvement, troubleshooting, and support deviations/quality events/non-conformances with a quality mindset.
Basic Requirements:
- BS or MS in Chemical Engineering (or closely related field).
- 4+ years industry experience in pharmaceutical process development, pilot plant operations, or chemical manufacturing.
- Authorization to work in the United States full-time (Lilly does not sponsor visas).
Additional Skills/Preferences:
- Hands-on kilo/pilot-scale processing experience.
- Software: DeltaV, Dynochem, Aspen, and/or electronic lab notebooks.
- Crystallization development (polymorph control, nucleation/growth kinetics, seeding, PSD control) and filtration modeling/parameter fitting for sizing/optimization.
- Knowledge of FDA guidelines and cGMP; strong attention to detail; ability to manage ambiguity; communication for technical writing/presentations; root-cause problem solving; cross-functional collaboration.
- Ability to work in manufacturing/lab environments; limited travel (<5%); possible nights/weekends.
Location:
- Initial: Parkwood West and Lilly Technology Center, Indianapolis. Permanent: Lilly Medicine Foundry, Lebanon, Indiana.
- Facilitate transfer of chemical processes (with appropriate supervisory guidance) from development labs to pilot plant operations (kilo-scale or pilot-scale) for 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 (AFD, tray dryer).
- Apply chemical engineering principles (heat/mass transfer, reaction kinetics, thermodynamics, fluid dynamics) for scale-up calculations and equipment sizing.
- Develop/apply cake filtration models; design and execute filtration wash studies.
- Model/semi-empirically predict and control particle size distribution (PSD) during crystallization.
- Receive process from early-phase R&D labs and evaluate incoming procedure safety with chemist and safety group.
- Author/review technical documents (SOPs, batch records, campaign summary reports, deviation reports).
- Perform and document definitive lab trials of crystallization steps; run familiarization reactions (focus on crystallization and filtration).
- Order/stage GMP consumables and equipment parts for kilolab runs.
- Summarize/present experimental results; analyze data for fact-based decisions; maintain detailed lab notebooks.
- Drive process improvement, troubleshooting, and support deviations/quality events/non-conformances with a quality mindset.
Basic Requirements:
- BS or MS in Chemical Engineering (or closely related field).
- 4+ years industry experience in pharmaceutical process development, pilot plant operations, or chemical manufacturing.
- Authorization to work in the United States full-time (Lilly does not sponsor visas).
Additional Skills/Preferences:
- Hands-on kilo/pilot-scale processing experience.
- Software: DeltaV, Dynochem, Aspen, and/or electronic lab notebooks.
- Crystallization development (polymorph control, nucleation/growth kinetics, seeding, PSD control) and filtration modeling/parameter fitting for sizing/optimization.
- Knowledge of FDA guidelines and cGMP; strong attention to detail; ability to manage ambiguity; communication for technical writing/presentations; root-cause problem solving; cross-functional collaboration.
- Ability to work in manufacturing/lab environments; limited travel (<5%); possible nights/weekends.
Location:
- Initial: Parkwood West and Lilly Technology Center, Indianapolis. Permanent: Lilly Medicine Foundry, Lebanon, Indiana.