宁波
职位详情
主要职责Job Description:
1、依据GMP规范开展无菌条件下的细胞摇瓶培养操作；
Responsible for conducting sterile cell culture in shake flasks in compliance with GMP standards;
2、熟练操作生物安全柜、摇床、细胞计数仪、台式离心机等实验设备；
Proficient in operating biosafety cabinets, shakers, cell counters, benchtop centrifuges and related equipment;
3、对生产过程中发生的偏差进行处理，完成根本原因调查并实施纠正与预防措施；
Address deviations occurred during production, conduct root cause investigations and implement corrective and preventive actions;
4、编写变更及验证方案，依照方案开展相关执行工作，并完成报告撰写；
Prepare change and validation protocols, carry out associated execution according to the protocols, and finalize reports;
5、编制与设备、工艺及运行相关的标准操作规程；
Develop standard operating procedures related to equipment, process, and operational activities;
6、负责GMP生产车间的环境管控，按文件规定执行设备的清洁与消毒任务；
Responsible for environmental control in GMP production areas, perform equipment cleaning and disinfection as per documented requirements;
7、及时、准确、规范地填写批生产记录、设备使用日志等各类记录文件；
Timely, accurately and properly complete batch production records, equipment usage logs and other documentation;
8、开展生产数据统计，提出物资需求，并完成采购申请及到货验收；
Conduct production data analysis, submit material requirements, and complete procurement requests and receipt inspection;
9、协助QA完成内部审计、客户审计以及官方监管检查工作；
Support QA in carrying out internal audits, client audits, and official regulatory inspections;
10、接收生产工艺方案，开展工艺评估并完成工艺放大工作。
Receive process packages, perform process evaluation, and execute process scale-up.
任职要求Job Requirement:
1、生物工程、分子生物学、微生物学、化学工程、药学等相关专业，本科及以上学历；
Biological engineering, molecular biology, microbiology, chemical engineering, pharmacy or related fields, bachelor's degree or above;
2、具备CHO细胞无菌培养的实际操作经验；
Hands-on experience in sterile culture of CHO cells;
3、熟悉GMP等相关法规要求，具有FDA、cGMP认证经历者优先考虑；
Familiar with GMP and related regulatory requirements, candidates with FDA or cGMP certification experience are preferred;
4、工作态度严谨细致，责任心强，具备良好的团队协作意识；
Demonstrate meticulous work attitude, strong responsibility, and good teamwork spirit;
5、具备基本的英语读写能力，能够满足日常工作的交流需要。
Possess basic English reading and writing skills to support daily job communication.
1、依据GMP规范开展无菌条件下的细胞摇瓶培养操作；
Responsible for conducting sterile cell culture in shake flasks in compliance with GMP standards;
2、熟练操作生物安全柜、摇床、细胞计数仪、台式离心机等实验设备；
Proficient in operating biosafety cabinets, shakers, cell counters, benchtop centrifuges and related equipment;
3、对生产过程中发生的偏差进行处理，完成根本原因调查并实施纠正与预防措施；
Address deviations occurred during production, conduct root cause investigations and implement corrective and preventive actions;
4、编写变更及验证方案，依照方案开展相关执行工作，并完成报告撰写；
Prepare change and validation protocols, carry out associated execution according to the protocols, and finalize reports;
5、编制与设备、工艺及运行相关的标准操作规程；
Develop standard operating procedures related to equipment, process, and operational activities;
6、负责GMP生产车间的环境管控，按文件规定执行设备的清洁与消毒任务；
Responsible for environmental control in GMP production areas, perform equipment cleaning and disinfection as per documented requirements;
7、及时、准确、规范地填写批生产记录、设备使用日志等各类记录文件；
Timely, accurately and properly complete batch production records, equipment usage logs and other documentation;
8、开展生产数据统计，提出物资需求，并完成采购申请及到货验收；
Conduct production data analysis, submit material requirements, and complete procurement requests and receipt inspection;
9、协助QA完成内部审计、客户审计以及官方监管检查工作；
Support QA in carrying out internal audits, client audits, and official regulatory inspections;
10、接收生产工艺方案，开展工艺评估并完成工艺放大工作。
Receive process packages, perform process evaluation, and execute process scale-up.
任职要求Job Requirement:
1、生物工程、分子生物学、微生物学、化学工程、药学等相关专业，本科及以上学历；
Biological engineering, molecular biology, microbiology, chemical engineering, pharmacy or related fields, bachelor's degree or above;
2、具备CHO细胞无菌培养的实际操作经验；
Hands-on experience in sterile culture of CHO cells;
3、熟悉GMP等相关法规要求，具有FDA、cGMP认证经历者优先考虑；
Familiar with GMP and related regulatory requirements, candidates with FDA or cGMP certification experience are preferred;
4、工作态度严谨细致，责任心强，具备良好的团队协作意识；
Demonstrate meticulous work attitude, strong responsibility, and good teamwork spirit;
5、具备基本的英语读写能力，能够满足日常工作的交流需要。
Possess basic English reading and writing skills to support daily job communication.
2026-09-25 15:34
IP属地：浙江宁波
职位福利
本科1-3年细胞培养
康龙化成(北京)新药技术股份有限公司
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