职位描述
职责描述:1.Responsible for SEC, IEC, CE method development, validation, transfer and sample analysis of therapeutic antibodies 负责治疗性抗体的理化分析方法包括分子排阻色谱，离子交换色谱，毛细管电泳等方法开发、验证、转移及样品检测。2.Hands-on scientific expertise and problem-solving skills in CE or HPLC analysis.有CE或HPLC分析的实际操作经验以及解决问题的技巧3.Co-ordinate with project teams to streamline the sample testing和项目团队合作做好样品的检测工作4.Performs instrumentation routine maintenance.进行常规的仪器的日常维护5.Fully document all protocols and results in notebook and compose summary report.在实验记录本上归档整理所有实验步骤和实验结果并总结报告。6.Write formal reports for regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.撰写用于申报材料的正式的报告文件并支持和书写合适的反馈来回答监管部门的问题。7.Additional responsibilities may include other physicochemical test of samples.工作职责还可能包括采用其他理化分析技术表征样品任职要求:1.PhD or MS 3+ years of experience in protein biochemistry, analytical chemistry, structural biology, immunobiology, pharmaceutical science or other related disciplines.蛋白质生物化学、分析化学、结构生物学、免疫学、药学或者其他相关背景的博士或者三年以上经验的硕士。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.在高效液相色谱和毛细管电泳、或其他蛋白质生物化学技术方面有完善的知识。有治疗性抗体IND/BLA申报经验的更佳。3.Ability to implement state of the art technologies to solve complex analyitical problems有能力用先进的技术手段解决复杂的分析问题4.Strong capabilities in experimental design and execution.在实验设计和执行方面有极强的能力。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，能够在跨功能团队中推进CMC开发项目。英语流利者更佳。
