Synthetic Chemist High Potency Lab - Lilly Medicine Foundry

Responsibilities

• Synthetically evaluate and facilitate the and transfer of chemical processes for highly potent molecules, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments).
• Perform synthetic chemistry and assess synthetic routes from early phase process research and development labs.
• Familiarity with performing chemistry in an isolator/glovebox.
• Experience working with highly potent molecules.
• Evaluate the safety of the incoming procedures in collaboration with the safety group and process engineering.
• Ordering and staging chemicals.
• Obtain reference materials and participate in setting up analytical methods.
• Reprocess and analyze analytical data to make fact-based decisions.
• Efficient with summarizing and presenting chemistry and challenges.
• Perform familiarization reactions to ensure plant readiness of process steps including chemical reactions, distillations, extractions, and crystallization/isolations at the Lilly Medicine Foundry.
• Perform use-tests of key raw materials and document Definitive Lab Trials of processes to confirm plant readiness.
• Maintain a well-organized and detailed lab notebook with accurate descriptions of the chemistry, observations, and organized analytical data to enable the preparation of technical packages/technical transfers and accurate replication in receiving labs.
• Documentation: Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
• 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.
• Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (CAPAs).

Qualifications

• B.S. or M.S. in chemistry, chemical engineering, or related field (Ph.D's will not be considered at this level).
• 3+ years of experience in synthetic chemistry and/or manufacturing environments involving synthetic small molecule API or drug substance.
• High potency chemical synthesis is preferred.

Additional Preferences

• Working knowledge of organic chemistry and mechanisms and application to reaction improvement and optimization.
• Experience with synthetic chemistry techniques used for developing and scaling-up chemical reactions.
• Experience using process chemistry concepts is a plus.
• Proficiency with the purification of chemicals via extraction, crystallization, chromatography, and distillation.
• Comfortable working with larger sized glass equipment.
• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
• Experience with a variety of analytical techniques: HPLC/UPLC, LC-MS, GC, NMR, IR, KF, XRPD, etc.
• Process quantification and acquiring mass balance for products and by-products.
• 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.
• Familiarity with crystallization and understanding of polymorphism and particle size control, and safe handling of solids/dry end processing.
• Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Able to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.