Job Responsibilities 工作职责:
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.
参与生化检测的分析方法开发,确认和方法转移以及撰写报告;进行生化分析,包括残留HCP、hcHCDNA、Protein A和胰岛素等;
2.Per SOPs, perform routine analysis of process development samples from MSAT, GMP samples, including in-process samples.
根据SOP执行MSAT 和GMP 样品的常规分析,包括中控样品等;
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.
参与蛋白质药物的结合分析、残留物分析的方法开发及优化, 独立完成抗体药物的蛋白結合力分析,包括各类生物分子结合能力实验;
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.
参与前期研发的生物药药性评估,产品稳定性研究分析,参与撰写稳定性研究报告和可比性报告;
5.Perform analytical data analysis, data review and trending analysis.
负责数据分析,数据审核和趋势分析;
6.Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
与公司内外各部门进行有效沟通,顺利推动项目按时完成;
7.Other work arranged by superior leaders.
上级领导安排的其他工作。
Qualification 任职资格:
1.Master degree or above, major in life science, chemistry, biochemistry, molecular biology.
硕士及以上学历,生命科学、化学、生物化学、分子生物学相关专业;
2.With 2-3 years of theoretical and practical foundation in protein science, structural biology and biochemistry.
具有2-3年蛋白质科学、细胞生物学和生物化学理论和实践基础;
3.Have experiences on HCP, residual DNA, residual Protein A, endotoxin and copy number measurement. Be familiar with equipment for biochemical analysis, such as SDS-PAGE, WB, ELISA, qPCR and etc.
具宿主细胞残留蛋白、残留DNA、残留蛋白A、内毒素,拷贝数的检测经验, 熟悉SDS-PAGE、WB、ELISA、qPCR和其他生化检验仪器的操作;
4.Practical experience in instrument analysis, familiar with protein interaction analysis, familiar with various analysis techniques, such as Biacore (SPR), ForteBio Octet (BLI), and Meso Scale Discovery (MSD).
具有仪器分析的实际操作经验,熟悉各种蛋白质结合力分析技术 (例如: 表面等离子共振SPR, 生物膜干涉技术BLI, 和多重因子超灵敏电化学发光MSD);
5.Excellent oral and written communication skills in English.
良好的英文读写和沟通能力。