Responsibility: 1.Responsible for the analytical method development of drug substance and drug product of mRNA pipelines; including raw materials and excipients. 负责mRNA药物研发阶段各种原辅料,原液(DS),成品(DP)的生物活性相关的分析方法的开发,评估 2.Perform in vitro biological activity analysis of mRNA drug substance (DS) and drug product (DP). May perform enzymatic activity assay of key materials 执行原辅料,中间品,mRNA原液(DS)和成品的活性检测,如酶活性,细胞抗原表达活性等的检测 3.Test in vivo animal immunity of possible mRNA finished products (DP). 参与可能的mRNA成品(DP)的动物免疫活性检测 4.Write SOPs for analysis and instrument operation; write analysis reports,experimental records, and IND declaration materials. 编写分析及仪器操作的SOP;撰写分析报告,实验记录以及IND申报资料。 5.Participate in the validation and transfer of analytical methods. 参与分析方法的验证与转移。 6.Other work assigned by supervisors. 上级安排的其他工作。
Qualifications: 1.Master's degree or above, majoring in cell biology, molecular biology, biochemistry or related fields 硕士及以上学历,细胞生物学、分析生物学、生物化学相关专业 2.5 years or more in related majors 5年以上相关经验 3.Use and maintenance of plate reader, BLI, flow cytometer, SPR, ELISA spot, MSD et al. 熟悉酶标仪, BLI, SPR, 流式细胞仪等相关仪器使用 4.Cell culture and Bioassay analysis competence,Ability to analyze and solve problems 有多种细胞培养与生物活性分析技能,能分析和解决分析方法中的问题 5.IND application 参与IND和NDA申报资料撰写