Sr Chemist - High Potency Lab Lilly Medicine Foundry
Eli Lilly and Company
9 hours ago
On-site
Lebanon, IN
Operations
Responsibilities:
- Facilitate transfer of chemical processes for highly potent molecules (under supervisory guidance) from development labs to pilot plant operations (including kilo-scale and isolator production environments) to support early-phase cGMP manufacturing of grams to kilogram quantities of API for clinical trials.
- Receive and evaluate incoming chemistry from process R&D labs for safety (with safety group and process engineering).
- Work with highly potent molecules in lab and production environments; perform chemistry in an isolator/glovebox.
- Order and stage chemicals; obtain reference materials and set up analytical methods.
- Reprocess and analyze analytical data to make fact-based decisions; summarize and present chemistry and challenges.
- Perform familiarization reactions to ensure plant readiness (reactions, distillations, extractions, crystallization/isolations).
- Conduct use-tests of key raw materials; document Definitive Lab Trials to confirm readiness.
- Maintain detailed lab notebooks for accurate replication and preparation of technical packages/technical transfers.
- Author/review technical documentation: tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports.
- Apply scientific knowledge to drive process improvement (new technologies/procedures).
- Support troubleshooting/investigations for deviations, quality events, and non-conformances; collaborate on RCA and CAPAs.
Basic Requirements:
- B.S. or M.S. in chemistry, chemical engineering, or related field.
- 3+ years of experience in manufacturing environments involving synthetic small molecule API/drug substance or fine chemical synthesis (preferred).
- Authorization to work in the United States on a full-time basis (no visa sponsorship).
Additional Preferences (Preferred Skills):
- Organic chemistry knowledge (mechanisms; reaction improvement/optimization).
- Synthetic chemistry and scale-up experience; process chemistry concepts (plus).
- Purification proficiency (extraction, crystallization, chromatography, distillation); large glass equipment.
- Motivation, fast learning, strong attention to detail.
- Experience creating batch records and conducting scale-up experiments.
- Ability to prioritize multiple activities and manage ambiguity.
- Analytical techniques: HPLC/UPLC, LC-MS, GC, NMR, IR, KF, XRPD, etc.
- Process quantification and mass balance for products/by-products.
- Ability to drive projects and accept change.
- Excellent written/verbal communication for technical reporting and collaboration.
- Crystallization/polymorphism/particle size control; safe handling of solids/dry end processing.
- Problem-solving including data analysis and RCA for complex technical challenges.
- Cross-functional work with engineers, analytical chemists, technicians, safety, and quality.
Benefits (as stated):
- Eligibility for 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (EAP, fitness, clubs/activities).
Application instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- Facilitate transfer of chemical processes for highly potent molecules (under supervisory guidance) from development labs to pilot plant operations (including kilo-scale and isolator production environments) to support early-phase cGMP manufacturing of grams to kilogram quantities of API for clinical trials.
- Receive and evaluate incoming chemistry from process R&D labs for safety (with safety group and process engineering).
- Work with highly potent molecules in lab and production environments; perform chemistry in an isolator/glovebox.
- Order and stage chemicals; obtain reference materials and set up analytical methods.
- Reprocess and analyze analytical data to make fact-based decisions; summarize and present chemistry and challenges.
- Perform familiarization reactions to ensure plant readiness (reactions, distillations, extractions, crystallization/isolations).
- Conduct use-tests of key raw materials; document Definitive Lab Trials to confirm readiness.
- Maintain detailed lab notebooks for accurate replication and preparation of technical packages/technical transfers.
- Author/review technical documentation: tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports.
- Apply scientific knowledge to drive process improvement (new technologies/procedures).
- Support troubleshooting/investigations for deviations, quality events, and non-conformances; collaborate on RCA and CAPAs.
Basic Requirements:
- B.S. or M.S. in chemistry, chemical engineering, or related field.
- 3+ years of experience in manufacturing environments involving synthetic small molecule API/drug substance or fine chemical synthesis (preferred).
- Authorization to work in the United States on a full-time basis (no visa sponsorship).
Additional Preferences (Preferred Skills):
- Organic chemistry knowledge (mechanisms; reaction improvement/optimization).
- Synthetic chemistry and scale-up experience; process chemistry concepts (plus).
- Purification proficiency (extraction, crystallization, chromatography, distillation); large glass equipment.
- Motivation, fast learning, strong attention to detail.
- Experience creating batch records and conducting scale-up experiments.
- Ability to prioritize multiple activities and manage ambiguity.
- Analytical techniques: HPLC/UPLC, LC-MS, GC, NMR, IR, KF, XRPD, etc.
- Process quantification and mass balance for products/by-products.
- Ability to drive projects and accept change.
- Excellent written/verbal communication for technical reporting and collaboration.
- Crystallization/polymorphism/particle size control; safe handling of solids/dry end processing.
- Problem-solving including data analysis and RCA for complex technical challenges.
- Cross-functional work with engineers, analytical chemists, technicians, safety, and quality.
Benefits (as stated):
- Eligibility for 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (EAP, fitness, clubs/activities).
Application instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.