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崗位職責(zé): Key responsibilities 主要職責(zé) 1.Responsible for physicochemical analysis and characterization of therapeutic antibodies, including methods such as: SEC, IEC, LC/MS, CE, SPR, various biophysical and spectrophotometry based methods. 負(fù)責(zé)治療性抗體的理化分析和表征，方法包括分子排阻色譜，離子交換色譜，液質(zhì)聯(lián)用，毛細(xì)管電泳，表面等離子共振以及各種生物物理和光譜相關(guān)的方法。 2.Develop, optimize and validate new analytical methods. 開發(fā)、優(yōu)化以及驗(yàn)證新的分析方法。 3.Support drug substance process development including characterization of starting materials, intermediates and final drug substance. 支持原液工藝開發(fā)，包括起始物，中間產(chǎn)物和最終原液的分析表征。 4.Support drug product formulation and process development including characterization of the process and finished product. 支持成品的制劑開發(fā)，包括中間和最終產(chǎn)物的表征分析。 5.Drug substance and drug product impurity characterization and identification. Analyze the stability issues of drug substance and drug product. 藥物原液和制劑的雜質(zhì)表征和鑒定。分析藥物原液和制劑的穩(wěn)定性問題。 6.Review analytical data for completeness and correctness. 審核分析數(shù)據(jù)的完整性和正確性。 7.Report and discuss analytical results and conclusions both orally and in writing. 口頭或書面報告和討論分析的結(jié)果和結(jié)論。 8.Write formal reports for inclusion in 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。 任職要求: Preferred qualification 首選的資格 1.MS in biochemistry, protein chemistry, structural biology or other protein science-related disciplines with three or more years of relevant experiences. Oversea study or working experience is a plus. 擁有三年以上經(jīng)驗(yàn)的生物化學(xué)、蛋白質(zhì)化學(xué)、結(jié)構(gòu)生物學(xué)或者其他蛋白質(zhì)科學(xué)相關(guān)背景的碩士，海外學(xué)習(xí)或工作經(jīng)驗(yàn)更佳。 2.Comprehensive knowledge of protein science with extensive experience in protein characterization. Experience working with therapeutic antibodies is a plus. 在蛋白質(zhì)科學(xué)方面有完整系統(tǒng)的知識并在蛋白質(zhì)表征方面有豐富的經(jīng)驗(yàn)。有治療性抗體研究經(jīng)驗(yàn)的更佳。 3.Extensive hands-on laboratory experience with and an in-depth knowledge of protein characterization techniques such as HPLC, LC/MS, CE, CD, DLS. 在蛋白質(zhì)表征技術(shù)例如高效液相色譜、液質(zhì)聯(lián)用、毛細(xì)管電泳、圓二色譜、動態(tài)光散射等方面有較多的實(shí)際操作經(jīng)驗(yàn)并有深厚的理論基礎(chǔ)。 4.Strong problem-solving and troubleshooting skills. 有較強(qiáng)的解決問題或排錯能力。 5.Strong capabilities in experimental design and execution. 在實(shí)驗(yàn)設(shè)計和執(zhí)行方面有極強(qiáng)的能力。 6.Strong collaborative teamwork and excellent communication skills, is energetic, highly self-motivated and able to work efficiently and productively in a growing company environment. 有較強(qiáng)的團(tuán)隊合作精神和優(yōu)秀的交流技巧，有活力，高度自我激勵并能夠在成長性企業(yè)氛圍中有效的工作。 7.Solid track record of publication, presentation, and achievement. 有較好的發(fā)表文章、報告和榮譽(yù)。