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; 5. 有参与过IND或生产申报成功项目经验的优先考虑； Experience in IND or manufacturing applications is preferred.
