• Act a key scientist to characterize therapeutic antibodies, ADC and fusion proteins.
• Design, develop and qualify potency assay to support lot release and stability study of drug substance and drug product.
• Perform a broad range of biochemical and cell-based assays, including but not limited immunoassay, Real-Time PCR, Flow Cytometry, Western Blot and other protein analysis. Maintain mammalian cells, insect cells and immune cells (lymphocytes, NK cells, dendritic cells, PBMC, etc.) for required experimental objectives.
• Lead and drive assay development, assay transfer and assay qualification activities within department and CRO
• Compile analytical data, perform data analysis and interpretation, prepare technical report, present data to project teams, give oral presentation at internal or external meetings.
• Troubleshoot method and instrumentation problems; be proactive in solving technical problems.
• Effectively plan and ensure project deliverables and timelines are met and contribute to mentoring and training team members
• Excellent oral and written communication skills; highly organized and efficient record keeping
Master or Ph.D’s degree in Biochemistry, Cell Biology, Molecular Biology or related discipline with a minimum of 2 years’ industry laboratory or 5 years’ academic research experience
• Experience with aseptic techniques, cell culture (suspension and adherent), cell-based potency assays, ELISAs and molecular biology techniques (PCR/qPCR) is preferred
• Strong hands-on experience with the development and qualification of luminescence/fluorometry/colorimetry-based assays
• Strong ability to multi-task and willingness to work effectively in highly collaborative and diverse environment.
• Demonstrated track record of completing tasks within established timelines
• Data processing skills using Windows based software (Excel, Softmax Pro, GraphPad Prizm, etc.)
• Strong aptitude to work collaboratively with internal and external partners