Advisor/Sr. Advisor - Bioconjugation Scientist

Responsibilities

• Facilitate the transfer of chemical processes for bioconjugation processes to produce ADCs and similar modalities, from development laboratories to pilot plant operations (including kilo-scale and production environments).
• Operate independently and guide more junior scientists.
• Evaluate the safety of 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.
• 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.
• 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).

Qualifications

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