Responsibilities:
- Facilitate transfer of bioconjugation chemical processes to produce ADCs and similar modalities from development labs to pilot plant (kilo-scale/production) environments for early-phase cGMP API manufacturing.
- Perform bioconjugation chemistry (antibody preparation, buffer exchanges, DAR analysis, aggregate assessment).
- Receive and assess incoming procedures for safety with safety/process engineering.
- Work with highly potent molecules/containment and single-use bioprocessing systems.
- Order/stage chemicals; obtain reference materials; set up analytical methods.
- Reprocess/analyze analytical data; summarize/present chemistry and challenges.
- Conduct familiarization/use-tests, lab trials, and confirm plant readiness of reactions (reduction/conjugation/oxidation) and TFF operations.
- Maintain detailed lab notebooks; author/review technical documents (tech transfer plan, SOPs, batch records, campaign and deviation reports).
- Apply scientific knowledge for process improvement; support troubleshooting, investigations, RCA, and CAPAs.
Basic Requirements:
- B.S. or M.S. in relevant field (biochemistry/chemical biology/conjugation chemistry/chemical engineering or related) plus 3+ years in manufacturing environments.
- Authorized to work in the U.S. full-time; no visa sponsorship.
Additional Preferences (selected):
- Organic chemistry/mechanisms; analytical methods (e.g., RP-HPLC, SEC, IEX, HIC, LC-MS, CE-SDS) and liquid chromatography/biconjugate purification.
- Synthetic chemistry and scale-up experience; comfort with glass and single-use equipment; batch records and scale-up per records; project leadership; strong written/verbal communication; cross-functional problem-solving.
Benefits (as stated):
- Eligible for company bonus (performance-based) and comprehensive benefits including 401(k), medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.