Job responsibilities
1、 根据公司发展战略，制定抗体项目CMC工艺开发研究计划并推动执行；
According to the company's strategy, develop CMC of antibodies research timeline and accountable for action item follow up
2、 与CDMO公司合作，建立用于抗体生产的可放大细胞培养工艺；
Cooperate with CDMO to establish a scalable cell culture process for the production
3、 并同时指导参与下游纯化工艺、分析和抗体制剂等方面的工作；
Guide and participate in the downstream purification process
4、 参与项目从合作公司或开发部门的技术转移；
Participate in the technology transfer from the cooperative company or R&D center;
5、 协助完成关于抗体工艺注册申报资料收集和撰写。
Participate in registration application
二、 任职要求
Job requirements
1、 生物工程、细胞生物学、生物化学与分子生物学、微生物学等硕士及以上学历，博士学历并有三年以上相关工作经验，或硕士学历并有五年以上相关工作经验；
Bioengineering, cell biology, biochemistry and molecular biology, microbiology, etc., doctoral degree with more than three years of relevant work experience, or master's degree with more than five years of experience
2、 有抗体上下游工艺开发经验，熟悉发酵、纯化和流程者，有ADC项目经验者优先
Experience in upstream and downstream process development of antibodies, familiar with fermentation, purification, experience in ADC project is preferred;
3、 熟悉NMPA、FDA和ICH法规者优先
Familiar with NMPA, FDA drug development, registration and other regulatory documents, and ICH guidelines
4、 良好的英语读写能力，能熟练的查阅专业英文文献。
Good English reading and writing skills is preferred

其他信息


所属部门：CMC