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Job Responsibilities 工作職責： 1. Participate in protein physicochemical analysis, including HPLC and CE related analytical methods，protein content by UV, etc. 參與蛋白理化分析，包括HPLC有關分析方法，毛細管電泳有關分析方法，UV蛋白含量檢測等； 2. Participate in analytical method development, qualification and method transfer. 參與理化檢測的分析方法開發，確認和方法轉移； 3. 3Per SOPs, perform routine analysis of process development samples from MSAT and other non-GMP samples, including in-process samples. 根據SOP執行MSAT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； 4. Provide analytical technical support to upstream and downstream process development groups during process development and troubleshooting. 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； 5. 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，草案，報告，風險評估，實驗室調查報告等； 6. Conduct the stability study, including long-term, accelerated and forced degradation stability tests. 執行穩定性實驗, 包括長期穩定性、加速穩定性、強制降解研究； 7. Write and review IND, BLA and other regulatory documents. 撰寫和審核IND,BLA和其他法規文件； 8. Perform analytical data analysis, data review and trending analysis. 負責數據分析，數據審核和趨勢分析； 9. Other work arranged by superior leaders. 上級領導安排的其他工作。