Sr Scientist - Bioconjugation Lilly Medicine Foundry

Responsibilities

• Facilitate the transfer of chemical processes for bioconjugation process’ to produce ADC’s and similar modalities, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and production environments).
• Enable the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.
• Experience performing bioconjugation chemistry to form ADC’s including antibody preparation, buffer exchanges and protein specific characterization (DAR analysis, aggregate assessment…).
• 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.
• Experience working with highly potent molecules and containment in the lab and production environments as well as working with single-use bioprocessing systems.
• 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 reduction/conjugation/oxidation reactions and Tangential Flow Filtration (TFF) operations at the Lilly Medicine Foundry.
• Ordering and staging chemicals. 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 with 3+ years of experience in manufacturing environments involving biochemistry, chemical biology , conjugation chemistry, chemical engineering or related field.
• Qualified applicants must be authorized to work in the United States on a full-time basis.

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.
• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
• Experience creating batch records and conducting scale-up experiments according to those records.
• Able 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.
• Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams.
• Problem-solving skills: 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.