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Job Responsibilities 工作職責：
1.Participate in analytical method development, qualification and method transfer and draft report; conduct biochemical analysis, including Residual HCP, hcHCDNA, ProteinA testing and Insulin, etc.
參與生化檢測的分析方法開發(fā)，確認和方法轉移以及撰寫報告；進行生化分析，包括殘留HCP、hcHCDNA、Protein A和胰島素等；
2.Per SOPs, perform routine analysis of process development samples from MSAT, GMP samples, including in-process samples.
根據SOP執(zhí)行MSAT 和GMP 樣品的常規(guī)分析，包括中控樣品等；
3.Participate in the development and of protein-protein interaction measurement, impurity determination and method optimization. Independent completion of protein binding measurement and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target binding ability experiments.
參與蛋白質藥物的結合分析、殘留物分析的方法開發(fā)及優(yōu)化, 獨立完成抗體藥物的蛋白結合力分析，包括各類生物分子結合能力實驗；
4.Participate in the preliminary research and development of biopharmaceutical evaluation, biological stability analysis, participate in the writing of stability research reports and comparability reports.
參與前期研發(fā)的生物藥藥性評估，產品穩(wěn)定性研究分析，參與撰寫穩(wěn)定性研究報告和可比性報告；
5.Perform analytical data analysis, data review and trending analysis.
負責數據分析，數據審核和趨勢分析；
6.Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
與公司內外各部門進行有效溝通，順利推動項目按時完成；
7.Other work arranged by superior leaders.
上級領導安排的其他工作。