Job Responsibilities 工作职责:
1.Responsible for cleaning equipment and cleaning areas, maintaining related facilities, and maintaining personal health and hygiene.
负责的清洁设备和洁净区域，维护相关设施，保持个人的健康和卫生；
2.Complete relevant training as required, and operate strictly in accordance with SOPs and BPRs. Strictly ensure that all production processes comply with the requirements of GMP and pharmaceutical production regulations.
按要求完成相关的培训，严格根据标准操作规程和批生产记录来操作；严格保证根据所有生产流程符合GMP和药品生产法规的要求；
3.Drafting and revising the documents of the production department, and filling in production-related applications and records. Author Shake Flask Cell Culture GMP documents. Author Bioreactor Cell Culture GMP documents. Author Harvest GMP documents. Author media/buffer preparation, washing and sterilization GMP documents. Author work clothes washing and production area cleaning GMP documents.
起草、修改生产部的文件，填写生产相关的申请和记录；起草摇瓶细胞培养生产相关的GMP文件；起草生物反应器细胞培养生产相关的GMP文件；起草收获相关的GMP文件。起草培养基/缓冲液配制、清洗和灭菌相关的GMP文件；工衣清洗相关的GMP文件；
4.Participate in the daily activities of production preparation, activities of the Shake Flask Cell Culture manufacturing, the production support, the Bioreactor Cell Culture manufacturing, activities of the harvest manufacturing group, cell culture in the bioreactor, including sampling, passage, counting, feeding, and on-duty, sampling, depth filtration and sterilization filtration, cell recovery, sampling, counting, passage in shake flask and cryopreservation, and preparation of small-scale media, the weighing and preparation of large-scale media and buffers, the washing of work clothes, the monitoring of the production process, review documents, the media/buffer weighing, preparation, washing and sterilization.
check all calculations (such as BPRs, labels, equipment readings, etc.).
参与生产准备，摇瓶细胞培养生产，生物反应器细胞培养生产，生产辅助，收获生产的日常活动；生物反应器中的细胞培养，包括取样、传代、计数、补料、值班；细胞的收获，包括取样，深层过滤和除菌过滤；大规模培养基和缓冲液的称量和配制; 培养基/缓冲液称量、配制、清洗、灭菌；参与工衣的清洗；细胞的复苏，取样，计数，摇瓶传代和冻存，小规模培养基的配制；生产过程的监控，审阅文件，检查所有的计算（例如批生产记录，标签，设备的读数等）；
5.Make production schedule and plan, cooperate with the project manager, communicate with external engineers and suppliers, lead the team to complete the company's production tasks.
制定生产排程和计划，与项目经理以及其他部门合作，与外部工程师和供应商沟通，领导团队完成公司的生产任务；
6.Lead the optimization of production process, troubleshooting to reduce production cost and solve complex process or equipment problems.
领导生产工艺的优化和故障排除，以降低生产成本和复杂工艺或设备问题的解决；
7.Manage the documents of the production department and review the reports related to production, check all calculations (e.g. batch records, label, equipment reading).
管理生产部的文件，审核与生产相关的报告，检查所有计算（如：批记录、标签、设备读数）；
8.Organize personnel/resources for Bioreactor Cell Culture manufacturing, Shake Flask Cell Culture manufacturing, harvest manufacturing media/buffer preparation, washing and sterilization, Work Clothes Washing, Sterilization, Sorting & Distribution, Production Area Cleaning, regulated according to cGMP to accomplish department goals and objectives while operating in a safe manner and in compliance with all applicable regulations.
按cGMP的要求，组织人员/资源，执行物反应器细胞培养生产，摇瓶细胞培养生产，培养基/缓冲液配制、清洗、灭菌，收获生产，工衣清洗、灭菌、整理和分发在满足安全操作和所有适用法规符合性的前提下，完成部门目标和任务；
9.Participate in the internal auditing program for CBL as required.
根据需要，参与CBL内部审计；
10.Assist MFG Manager in hosting regulatory or due diligence inspections. Act as SME to regulatory agencies. Oversee the timely response and follow-up to any observations.
协助生产经理，接待监管或尽职相关的检查；作为监管机构的SME；督促针对各种观察项的及时反馈和跟进；
11.Train other technicians in group and individual settings on best practices and compliance to SOPs.
作为团队或个人讲师，培训其他技术人员，使达到最优的操作实践和SOP依从性；
12.Determine GMP training requirements and curricula. Design and conduct, or outsource, training courses to enhance GMP knowledge level among company personnel.
决定GMP培训的要求和课程；为了提高公司员工的GMP知识水准，设计、安排或外购培训课程；
13.Serve as group representative on cross-functional teams. Communicate effectively and professionally.
在跨职能团队中，作为小组代表。高效、专业地沟通；
14.Anticipate potential problems and take preventative action.
能预见潜在的问题，并采取预防性措施；
15.Apply appropriate PPE to complete all work to ensure compliance with the company EHS requirements.
应用适当的个人防护用品去完成所有工作，确保符合公司环境健康安全的要求。

Qualification 任职资格:
1.Degree of junior college or above in Biochemistry, Cell biology, Microbiology, Fermentation engineering, Life Sciences or relevant background.
专科及以上学历，生物化学、细胞生物学、微生物、发酵工程、生命科学或者相关专业；
2.Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs, the process solution preparation, the process of bacteria fermentation or cell culture, the process of large-scale bacteria fermentation or cell culture, the process of membrane filtration.
对于生物制药技术有一定了解，特别是单克隆抗体或者重组融合蛋白药物的工艺流程，工艺溶液配制，细菌发酵或细胞培养，大规模细菌发酵或细胞培养，膜过滤的工艺流程；
3.Thorough, in-depth knowledge of cell culture, solution preparation, centrifugation and membrane filtration technology.
对细胞培养，配液、离心和膜过滤技术，有全面、深入的了解；
4.Must be flexible to work on any shift (day, night and weekend) and capable of standing for a long time to work.
必须灵活的参与任何轮班(白班，晚班，周末)，并能够长时间站立工作；
5.Oral and written communication skills in Chinese and English.
良好的中英文读写和沟通能力。