職位描述
職責(zé)描述:1.Responsible for SEC, IEC, CE method development, validation, transfer and sample analysis of therapeutic antibodies 負(fù)責(zé)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(xì)管電泳等方法開發(fā)、驗(yàn)證、轉(zhuǎn)移及樣品檢測(cè)。2.Hands-on scientific expertise and problem-solving skills in CE or HPLC analysis.有CE或HPLC分析的實(shí)際操作經(jīng)驗(yàn)以及解決問題的技巧3.Co-ordinate with project teams to streamline the sample testing和項(xiàng)目團(tuán)隊(duì)合作做好樣品的檢測(cè)工作4.Performs instrumentation routine maintenance.進(jìn)行常規(guī)的儀器的日常維護(hù)5.Fully document all protocols and results in notebook and compose summary report.在實(shí)驗(yàn)記錄本上歸檔整理所有實(shí)驗(yàn)步驟和實(shí)驗(yàn)結(jié)果并總結(jié)報(bào)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(bào)材料的正式的報(bào)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(zé)還可能包括采用其他理化分析技術(shù)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(zhì)生物化學(xué)、分析化學(xué)、結(jié)構(gòu)生物學(xué)、免疫學(xué)、藥學(xué)或者其他相關(guān)背景的博士或者三年以上經(jīng)驗(yàn)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(xì)管電泳、或其他蛋白質(zhì)生物化學(xué)技術(shù)方面有完善的知識(shí)。有治療性抗體IND/BLA申報(bào)經(jīng)驗(yàn)的更佳。3.Ability to implement state of the art technologies to solve complex analyitical problems有能力用先進(jìn)的技術(shù)手段解決復(fù)雜的分析問題4.Strong capabilities in experimental design and execution.在實(shí)驗(yàn)設(shè)計(jì)和執(zhí)行方面有極強(qiáng)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(tuán)隊(duì)中推進(jìn)CMC開發(fā)項(xiàng)目。英語流利者更佳。
