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崗位職責(zé):

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(kāi)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(wèn)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(xiě)用于申報(bào)材料的正式的報(bào)告文件并支持和書(shū)寫(xiě)合適的反饋來(lái)回答監(jiān)管部門(mén)的問(wèn)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

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(wèn)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(kāi)發(fā)項(xiàng)目。英語(yǔ)流利者更佳。