Principal Scientist – Process Translation and Execution

Role Overview

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

Requirements

• BS or MS in Chemical Engineering or a closely related discipline
• 8+ years of industry experience
• in pharmaceutical process development, pilot plant operations, or chemical manufacturing.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• 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.
• A good understanding of FDA guidelines and cGMP requirements.
• Ability to prioritize multiple activities and manage ambiguity.
• Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.

Benefits

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)