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Job Responsibilities/工作職責 1. Independent completion of biological activity screening and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target binding ability experiments, and biological activity experiments based on specific cell biological mechanisms. 獨立完成抗體藥物分析的生物活性篩選評估實驗，包括但不限于各類生物分子靶點結(jié)合能力實驗，以特異細胞生物機理的生物活性實驗； 2. Participate in the bioassay development, including ADCC, CDC, ELISA binding and cell-based assays. 參與活性分析方法開發(fā)，包括ADCC、CDC、ELISA結(jié)合活性、細胞生物活性試驗等； 3. Perform routine analysis of samples of process development from MSAT and other non-GMP samples, including in-process samples. 執(zhí)行MSAT部門公藝開發(fā)樣品和其它non-GMP 樣品的常規(guī)分析，包括中控樣品等； 4. Participate in the method development and validation of protein drug analytical method; implement the preparation of SOP and method validation reports. 參與蛋白藥物檢測方法開發(fā)及驗證; 執(zhí)行SOP與方法學驗證報告的撰寫； 5. Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc. 負責管理技術(shù)文件包括操作規(guī)程，草案，報告，風險評估，實驗室調(diào)查報告等； 6. Present to cross functional teams and effectively communicate critical analytical issues and solutions. 針對關(guān)鍵問題與跨模塊團隊合作, 有效溝通, 并提出解決方案； 7. Communicate effectively with the company’s internal and external departments to successfully complete the project on time. 與公司內(nèi)外各部門進行有效溝通，順利推動項目按時完成； 8. Other work arranged by superior leaders. 上級領(lǐng)導安排的其他工作。 Job Requirements/崗位要求 1. Master major in cell biology, molecular biology or life sciences. With 2 years or more of experience in ligand binding and cell-based assay development. Perform bioassays independently. With R&D experience is a plus. 碩士學歷，細胞生物、分子生物學、生命科學相關(guān)專業(yè)，具有2年及以上結(jié)合活性與細胞活性開發(fā)經(jīng)驗，能獨立完成生物活性檢驗, 具備研發(fā)經(jīng)驗尤佳； 2. Have practical operation experience in instrument analysis, familiar with various analysis techniques (e.g. cell-based potency assay, ELISA binding, MSD, BLI, neutralization assay, FACS, ADCC and CDC), and master various biochemical test methods, confirmation, verification and transfer processes. 具有儀器分析的實際操作經(jīng)驗，熟悉各種分析技術(shù)(細胞活性分析、ELISA結(jié)合活性、MSD、BLI、中和試驗、FACS、ADCC和CDC)，對上下游工作流程熟悉，并熟練掌握各種生化測試方法、確認、驗證和轉(zhuǎn)移過程； 3. Understand ICH, USP, ChP regulations and guidelines. 了解ICH, USP, ChP法規(guī)和指導原則； 4. Excellent oral and written communication skills in English. 良好的英文讀寫和溝通能力。