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细胞摇瓶培养操作；
Responsible for conducting sterile cell culture in shake flasks under GMP guidelines;
2、熟练操作生物安全柜、振荡培养箱、细胞计数仪、台式离心机等实验设备；
Proficient in operating biosafety cabinets, orbital shakers, cell counters, benchtop centrifuges and related instruments;
3、对生产过程中发生的偏差进行处理，完成根本原因分析并实施纠正与预防措施；
Handle production deviations, conduct investigations, and implement corrective and preventive actions (CAPA);
4、编制变更控制及工艺验证方案，依照方案执行相关工作并撰写总结报告；
Prepare change control and process validation protocols, carry out associated tasks according to the plans, and generate reports;
5、编写与设备、工艺流程及运行管理相关的标准操作规程；
Draft standard operating procedures related to equipment, manufacturing processes, and operational activities;
6、负责GMP生产区域的环境管控，按文件规定完成设备的清洁与消毒作业；
Responsible for maintaining the environment in GMP production areas and performing equipment cleaning and disinfection as per documented procedures;
7、及时、准确、规范地填写批生产记录、设备使用日志等各类原始记录；
Timely, accurately, and properly complete batch production records, equipment usage logs, and other relevant documentation;
8、开展生产数据统计分析，提出物料需求，并参与采购执行及到货验收；
Conduct statistical analysis of production data, submit material requirements, and participate in procurement and receiving processes;
9、协助质量保证部门完成内部审计、客户审计以及官方监管机构的检查工作；
Support QA in completing internal audits, client audits, and inspections by regulatory authorities;
10、接收新工艺技术，完成工艺评估及从小试到中试的放大研究。
Receive new processes, perform process evaluation, and conduct scale-up from lab to pilot scale.
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等法规要求，具有FDA、cGMP认证经历者优先考虑；
Familiar with GMP and related regulatory requirements, prior experience with FDA or cGMP certification is preferred;
4、工作态度严谨细致，具备较强的责任意识和团队协作能力；
Demonstrate meticulous work attitude, strong sense of responsibility, and good team cooperation spirit;
5、具备基本的英语应用能力，能够满足日常工作中读写交流需要。
Possess basic English proficiency to support daily communication, reading, and writing tasks.
1、依据GMP规范开展无菌条件下细胞摇瓶培养操作；
Responsible for conducting sterile cell culture in shake flasks under GMP guidelines;
2、熟练操作生物安全柜、振荡培养箱、细胞计数仪、台式离心机等实验设备；
Proficient in operating biosafety cabinets, orbital shakers, cell counters, benchtop centrifuges and related instruments;
3、对生产过程中发生的偏差进行处理，完成根本原因分析并实施纠正与预防措施；
Handle production deviations, conduct investigations, and implement corrective and preventive actions (CAPA);
4、编制变更控制及工艺验证方案，依照方案执行相关工作并撰写总结报告；
Prepare change control and process validation protocols, carry out associated tasks according to the plans, and generate reports;
5、编写与设备、工艺流程及运行管理相关的标准操作规程；
Draft standard operating procedures related to equipment, manufacturing processes, and operational activities;
6、负责GMP生产区域的环境管控，按文件规定完成设备的清洁与消毒作业；
Responsible for maintaining the environment in GMP production areas and performing equipment cleaning and disinfection as per documented procedures;
7、及时、准确、规范地填写批生产记录、设备使用日志等各类原始记录；
Timely, accurately, and properly complete batch production records, equipment usage logs, and other relevant documentation;
8、开展生产数据统计分析，提出物料需求，并参与采购执行及到货验收；
Conduct statistical analysis of production data, submit material requirements, and participate in procurement and receiving processes;
9、协助质量保证部门完成内部审计、客户审计以及官方监管机构的检查工作；
Support QA in completing internal audits, client audits, and inspections by regulatory authorities;
10、接收新工艺技术，完成工艺评估及从小试到中试的放大研究。
Receive new processes, perform process evaluation, and conduct scale-up from lab to pilot scale.
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等法规要求，具有FDA、cGMP认证经历者优先考虑；
Familiar with GMP and related regulatory requirements, prior experience with FDA or cGMP certification is preferred;
4、工作态度严谨细致，具备较强的责任意识和团队协作能力；
Demonstrate meticulous work attitude, strong sense of responsibility, and good team cooperation spirit;
5、具备基本的英语应用能力，能够满足日常工作中读写交流需要。
Possess basic English proficiency to support daily communication, reading, and writing tasks.
2026-06-26 13:05
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
工作地址
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附近适合您的职位
长白班月薪8000+
6000-8000元/月
其他生产营运人员生产运营包吃免费培训包住20人以上月结经验不限学历不限全职厂内食堂月结工资不穿无尘服车间流水线
宁波 北仑区
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