職位描述
職責描述:1.Responsible for SEC, IEC, CE method development, validation, transfer and sample analysis of therapeutic antibodies 負責治療性抗體的理化分析方法包括分子排阻色譜，離子交換色譜，毛細管電泳等方法開發(fā)、驗證、轉移及樣品檢測。2.Hands-on scientific expertise and problem-solving skills in CE or HPLC analysis.有CE或HPLC分析的實際操作經(jīng)驗以及解決問題的技巧3.Co-ordinate with project teams to streamline the sample testing和項目團隊合作做好樣品的檢測工作4.Performs instrumentation routine maintenance.進行常規(guī)的儀器的日常維護5.Fully document all protocols and results in notebook and compose summary report.在實驗記錄本上歸檔整理所有實驗步驟和實驗結果并總結報告。6.Write formal reports for regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.撰寫用于申報材料的正式的報告文件并支持和書寫合適的反饋來回答監(jiān)管部門的問題。7.Additional responsibilities may include other physicochemical test of samples.工作職責還可能包括采用其他理化分析技術表征樣品任職要求:1.PhD or MS 3+ years of experience in protein biochemistry, analytical chemistry, structural biology, immunobiology, pharmaceutical science or other related disciplines.蛋白質生物化學、分析化學、結構生物學、免疫學、藥學或者其他相關背景的博士或者三年以上經(jīng)驗的碩士。2.Comprehensive knowledge of HPLC and capillary electrophoresis, or other protein biochemistry techniques. Experience of working with therapeutic antibodies IND/BLA filing is a plus.在高效液相色譜和毛細管電泳、或其他蛋白質生物化學技術方面有完善的知識。有治療性抗體IND/BLA申報經(jīng)驗的更佳。3.Ability to implement state of the art technologies to solve complex analyitical problems有能力用先進的技術手段解決復雜的分析問題4.Strong capabilities in experimental design and execution.在實驗設計和執(zhí)行方面有極強的能力。5.Exceptional communication skills and the ability to work in a cross-functional team environment to advance CMC development projects. Fluent in English is a plus.有非常好的交流能力，能夠在跨功能團隊中推進CMC開發(fā)項目。英語流利者更佳。
