Principal Scientist - Process Translation and Execution Lilly Medicine Foundry

Responsibilities

• Facilitate the transfer of chemical processes from development laboratories to pilot plant operations (including kilo-scale or pilot-scale production).
• Operate and troubleshoot kilo-scale equipment such as 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 processes from early phase process research and development labs and evaluate 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.
• Ordering and staging process-related GMP consumables and equipment parts for kilolab runs.
• Efficiently summarize and present 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.

Requirements

• 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

Basic Requirements

• Authorized to work in the United States on a full-time basis

Additional Skills and Preferences

• 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 change
• Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams
• Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges
• Ability to work cross-functionally across disciplines and levels with process chemists, analytical chemists, chemical technicians, safety and quality representatives