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Job Responsibilities/工作職責(zé) 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(dú)立完成抗體藥物分析的生物活性篩選評(píng)估實(shí)驗(yàn)，包括但不限于各類生物分子靶點(diǎn)結(jié)合能力實(shí)驗(yàn)，以特異細(xì)胞生物機(jī)理的生物活性實(shí)驗(yàn)； 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(xì)胞生物活性試驗(yàn)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(yàn)證; 執(zhí)行SOP與方法學(xué)驗(yàn)證報(bào)告的撰寫； 5. Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc. 負(fù)責(zé)管理技術(shù)文件包括操作規(guī)程，草案，報(bào)告，風(fēng)險(xiǎn)評(píng)估，實(shí)驗(yàn)室調(diào)查報(bào)告等； 6. Present to cross functional teams and effectively communicate critical analytical issues and solutions. 針對(duì)關(guān)鍵問題與跨模塊團(tuán)隊(duì)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(jìn)行有效溝通，順利推動(dòng)項(xiàng)目按時(shí)完成； 8. Other work arranged by superior leaders. 上級(jí)領(lǐng)導(dǎo)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(xué)歷，細(xì)胞生物、分子生物學(xué)、生命科學(xué)相關(guān)專業(yè)，具有2年及以上結(jié)合活性與細(xì)胞活性開發(fā)經(jīng)驗(yàn)，能獨(dú)立完成生物活性檢驗(yàn), 具備研發(fā)經(jīng)驗(yàn)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(shí)際操作經(jīng)驗(yàn)，熟悉各種分析技術(shù)(細(xì)胞活性分析、ELISA結(jié)合活性、MSD、BLI、中和試驗(yàn)、FACS、ADCC和CDC)，對(duì)上下游工作流程熟悉，并熟練掌握各種生化測試方法、確認(rèn)、驗(yàn)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(dǎo)原則； 4. Excellent oral and written communication skills in English. 良好的英文讀寫和溝通能力。