61 Strategic thinking and research skills to reduce complicated drug clinical effects into simple clear analytical attributes at the cellular or molecular levels, hence defining the quality of the drug.
61 Innovation skills in development of cutting-edge cell-based assays, molecular biological assays and immunoassays in support of therapeutic antibody or other biotech product portfolio.
61 Gradually manage a team of junior scientists to conduct bioassay development, qualification / validation and sample testing for lot release, in-process, stability and R&D samples under a GMP environment until established as part of a clinical control system.
61 Transfer, training, and trouble-shooting of cell-based assays to collaborating QC labs
61 Represent the department in CMC team for selected integrated and standalone projects.
61 Draft and review regulatory submissions including INDs and BLAs. Interaction with regulatory agencies such as US FDA and China NMPA on a regular basis.
Basic Qualifications:
61 PhD or MS in Biochemistry / Biotechnology, Cell Biology, Immunology, or related field.
61 0-2 years for PhD or MS of industrial experience in functional biochemical, cell-based assay, and potency assay.
61 Strong technical innovation and trouble-shooting skills in cell biology, molecular biology and biochemical research.
61 In-depth knowledge with cellular models of diseases, protein interaction, immunoassay, flow cytometry, cell signal transduction, immune regulation and mammalian cell culture.
61 Excellent spoken and written communication skills in English is a must.
61 Experience with regulatory filings preferred.