岗位描述
Job Description
1.	在GMP车间内参加免疫细胞产品的生产操作，以及生产准备和清场活动；
Participate in production operation of cell products in GMP facility, as well as production preparation and clearance activities;
2.	参与生产工艺的开发，优化和技术转移等工作;
Participate in production process development, optimization and technology transfer.
3.	起草生产相关的工艺操作SOP文件和流程管理SMP文件等;
Draft the documents of process operation SOP and process management SMP related to the production;
4.	支持质量系统相关的风险评估和控制，包括偏差调查，预防纠正措施和变更控制;
Support the risk assessment and control related quality system, including deviation investigation, preventive corrective action and change control.
5.	撰写和审核CMC需求相关的方案和报告;
Draft and review the reports or document related to the requirements of CMC;
6.	确保安全的方式去执行所有的工作，操作符合EHS要求；
Ensure all work is performed in a safe manner and in accordance with EHS requirements;
7.	清洁和维护GMP厂房和生产设备,保持环境和个人卫生；
Clean and maintain GMP plant and production equipment, maintain environmental and personal hygiene;
8．	部门负责人交待的其他事项。
Other matters assigned by the department head.


岗位要求：
Job Requirements
1.	生物学、微生物学、细胞生物学、生物科学、生物工程、生物技术、生物制药及其他生物相关专业，硕士学历,有海外学习经验优先。
Master’s degree in Biology, Microbiology, Cell Biology, Biological Science, Bioengineering, Biotechnology, Biopharmaceutical or other related disciplines; Overseas study experience is preferred.
2.	具备免疫细胞细胞分离、培养、冻存、复苏等相关经验者优先；
Experience in Immune cell isolation, culture, cryopreservation and resuscitation is preferred;
3.	熟悉生物制药领域GMP的相关法规要求；
Familiar with GMP related regulations and requirements in biopharmaceutical field；
4.	英语六级以上，有一定的数据处理和统计分析能力；
CET 6 or above, good at data processing and statistical analysis;