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Job Responsibilities 工作職責： 1.Participate in protein LC-MS characterization, including molecular weight, peptide mapping sequence coverage, disulfide linkage, glycosylation site, and post-translational modifications (PTM). 參與蛋白質(zhì)譜結(jié)構(gòu)表征，包括分子量、肽圖序列覆蓋率、二硫鍵、糖基化位點和翻譯后修飾等； 2.Participate in characterization and analytical method development. 參與表征和分析方法開發(fā)； 3.Provide analytical technical support to upstream/downstream process development groups during process development and trouble shooting. Support formulation development, tech transfer and scale-up activities. 對上下游的工藝開發(fā)提供分析支持并協(xié)助排查與解決問題，對制劑開發(fā)、技術(shù)轉(zhuǎn)移、放大工藝提供分析技術(shù)支持； 4.Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc. 負責起草技術(shù)文件包括操作規(guī)程，方案，報告，風(fēng)險評估，實驗室調(diào)查報告等； 5.Per SOPs, perform routine analysis of samples of process development from PD and other non-GMP samples, including in-process samples. 根據(jù)SOP執(zhí)行PD部門工藝開發(fā)樣品和其它non-GMP 樣品的常規(guī)分析，包括中控樣品等； 6.Perform analytical data analysis, data review and trending analysis. 負責數(shù)據(jù)分析，數(shù)據(jù)審核和趨勢分析； 7.Other work arranged by superior leaders. 上級領(lǐng)導(dǎo)安排的其他工作。