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Job Responsibilities 工作職責(zé)： 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(guān)分析方法，毛細(xì)管電泳有關(guān)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(fā)，確認(rèn)和方法轉(zhuǎn)移； 3. 3Per SOPs, perform routine analysis of process development samples from MSAT and other non-GMP samples, including in-process samples. 根據(jù)SOP執(zhí)行MSAT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； 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(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； 5. Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc. 負(fù)責(zé)起草技術(shù)文件包括操作規(guī)程，草案，報告，風(fēng)險評估，實驗室調(diào)查報告等； 6. Conduct the stability study, including long-term, accelerated and forced degradation stability tests. 執(zhí)行穩(wěn)定性實驗, 包括長期穩(wěn)定性、加速穩(wěn)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(guī)文件； 8. Perform analytical data analysis, data review and trending analysis. 負(fù)責(zé)數(shù)據(jù)分析，數(shù)據(jù)審核和趨勢分析； 9. Other work arranged by superior leaders. 上級領(lǐng)導(dǎo)安排的其他工作。