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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). 參與蛋白質譜結構表征，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； 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提供分析支持并協助排查與解決問題，對制劑開發、技術轉移、放大工藝提供分析技術支持； 4.Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc. 負責起草技術文件包括操作規程，方案，報告，風險評估，實驗室調查報告等； 5.Per SOPs, perform routine analysis of samples of process development from PD and other non-GMP samples, including in-process samples. 根據SOP執行PD部門工藝開發樣品和其它non-GMP 樣品的常規分析，包括中控樣品等； 6.Perform analytical data analysis, data review and trending analysis. 負責數據分析，數據審核和趨勢分析； 7.Other work arranged by superior leaders. 上級領導安排的其他工作。