Sr Scientist - Bioconjugation Lilly Medicine Foundry
Eli Lilly and Company
9 hours ago
On-site
Lebanon, IN
Clinical Research and Development
Responsibilities:
- Facilitate transfer of bioconjugation chemical processes to produce ADCs and similar modalities from development labs to pilot plant operations (including kilo-scale and production environments) to support early-phase cGMP manufacturing of grams to kilogram quantities of API.
- Perform bioconjugation chemistry (antibody preparation, buffer exchanges, protein characterization such as DAR analysis and aggregate assessment).
- Receive early-phase chemistry and evaluate safety of incoming procedures with safety group and process engineering.
- Work with highly potent molecules, containment practices, and single-use bioprocessing systems.
- Order and stage chemicals; obtain reference materials; set up analytical methods.
- Reprocess and analyze analytical data to make fact-based decisions; summarize and present chemistry and challenges.
- Conduct familiarization reactions to ensure plant readiness (reduction/conjugation/oxidation; Tangential Flow Filtration (TFF)).
- Perform use-tests of key raw materials and document definitive lab trials to confirm plant readiness.
- Maintain detailed lab notebooks for accurate technical packages/technical transfers and replication.
- Author/review technical documents (tech transfer plans, SOPs, batch records, campaign summary and deviation reports).
- Apply scientific knowledge for process improvement; support troubleshooting, investigations, RCA, and CAPAs.
Basic Requirements:
- B.S. or M.S. in a relevant field (biochemistry, chemical biology, conjugation chemistry, chemical engineering, or related) with 3+ years of experience in manufacturing environments.
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Preferences:
- Organic chemistry knowledge/mechanisms; reaction improvement/optimization.
- Hands-on analytical methods for small molecules and biomolecules (RP-HPLC, SEC, IEX, HIC, LC-MS, CE-SDS).
- Hands-on liquid chromatography for bioconjugate purification and chromatography systems.
- Synthetic chemistry and scale-up experience; process chemistry concepts.
- Comfortable with larger glass equipment and single-use equipment; high attention to detail.
- Experience creating batch records and conducting scale-up experiments; prioritize multiple activities in ambiguity.
- Process quantification and mass balance.
- Strong communication (technical reports/presentations) and problem-solving (data analysis, RCA).
- Ability to work cross-functionally with engineers, analytical chemists, technicians, safety, and quality.
Benefits (if applicable):
- Eligible for company bonus (depending on company/individual performance) and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, leave benefits, and well-being benefits.
Other/Role Info:
- Initial location: Lilly Technology Center, Indianapolis; permanent location: Lilly Medicine Foundry, Lebanon, Indiana.
- Limited travel (<5%); requires ability to work in manufacturing and laboratory environments.
- Facilitate transfer of bioconjugation chemical processes to produce ADCs and similar modalities from development labs to pilot plant operations (including kilo-scale and production environments) to support early-phase cGMP manufacturing of grams to kilogram quantities of API.
- Perform bioconjugation chemistry (antibody preparation, buffer exchanges, protein characterization such as DAR analysis and aggregate assessment).
- Receive early-phase chemistry and evaluate safety of incoming procedures with safety group and process engineering.
- Work with highly potent molecules, containment practices, and single-use bioprocessing systems.
- Order and stage chemicals; obtain reference materials; set up analytical methods.
- Reprocess and analyze analytical data to make fact-based decisions; summarize and present chemistry and challenges.
- Conduct familiarization reactions to ensure plant readiness (reduction/conjugation/oxidation; Tangential Flow Filtration (TFF)).
- Perform use-tests of key raw materials and document definitive lab trials to confirm plant readiness.
- Maintain detailed lab notebooks for accurate technical packages/technical transfers and replication.
- Author/review technical documents (tech transfer plans, SOPs, batch records, campaign summary and deviation reports).
- Apply scientific knowledge for process improvement; support troubleshooting, investigations, RCA, and CAPAs.
Basic Requirements:
- B.S. or M.S. in a relevant field (biochemistry, chemical biology, conjugation chemistry, chemical engineering, or related) with 3+ years of experience in manufacturing environments.
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Preferences:
- Organic chemistry knowledge/mechanisms; reaction improvement/optimization.
- Hands-on analytical methods for small molecules and biomolecules (RP-HPLC, SEC, IEX, HIC, LC-MS, CE-SDS).
- Hands-on liquid chromatography for bioconjugate purification and chromatography systems.
- Synthetic chemistry and scale-up experience; process chemistry concepts.
- Comfortable with larger glass equipment and single-use equipment; high attention to detail.
- Experience creating batch records and conducting scale-up experiments; prioritize multiple activities in ambiguity.
- Process quantification and mass balance.
- Strong communication (technical reports/presentations) and problem-solving (data analysis, RCA).
- Ability to work cross-functionally with engineers, analytical chemists, technicians, safety, and quality.
Benefits (if applicable):
- Eligible for company bonus (depending on company/individual performance) and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, leave benefits, and well-being benefits.
Other/Role Info:
- Initial location: Lilly Technology Center, Indianapolis; permanent location: Lilly Medicine Foundry, Lebanon, Indiana.
- Limited travel (<5%); requires ability to work in manufacturing and laboratory environments.