Advisor/Sr. Advisor - Bioconjugation Scientist

Responsibilities

• Experience performing bioconjugation chemistry to form ADCs including antibody preparation, buffer exchanges and protein specific characterization (DAR analysis, aggregate assessment).
• Hands-on experience across multiple conjugation strategies (maleimide, click, enzymatic).
• Experience working with highly potent molecules and containment in the lab and production environments as well as working with single-use bioprocessing systems.
• Ability to mentor less experienced scientists and ultimately supervise colleagues.
• Ability to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.
• Actively involved in receiving chemistry from early phase process research and development labs and evaluating the safety of the incoming procedures in collaboration with the safety group and process engineering.
• Ensure raw material and reagent readiness, 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 reduction/conjugation/oxidation reactions and Tangential Flow Filtration (TFF) operations 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.
• Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
• 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).

Basic Requirements

B.S. or M.S. with 6+ years of experience or PhD with 2+ years of experience in manufacturing environments involving biochemistry, chemical biology, conjugation chemistry, chemical engineering or related field.

Additional Preferences

• Working knowledge of organic chemistry and mechanisms and application to reaction improvement and optimization.
• Knowledge of and hands-on experience with analytical methods used for small molecules and biomolecules (RP-HPLC, SEC, IEX, HIC, LC-MS, CE-SDS).
• Hands-on experience with liquid chromatography: bioconjugate purification and familiarity with chromatography systems.
• Experience with synthetic chemistry techniques used for developing and scaling-up chemical reactions.
• Experience using process chemistry concepts is a plus.
• Comfortable working with larger sized glass equipment as well as single use equipment.
• Demonstrated ability to independently lead a technology transfer end to end, from development lab to clinical manufacturing.
• Has experience creating batch records and conducting scale-up experiments according to those records.
• Ability to prioritize multiple activities and manage ambiguity.
• Process quantification and acquiring mass balance for products and by-products.
• Demonstrated ability to drive projects and accept change.
• Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
• Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Ability to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.

Other Information

Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Limited domestic and international travel (< 5%) may be required for this role. Role requires ability to work in manufacturing and laboratory environments.