锦鲤求职岗位描述
1. 最低任职要求Minimum Requirement
教育程度/经验Education background/ Experience
本科以上学历，生物、化学、制药工程等相关专业，或具有同等工作经验的人员
Bachelor degree or above, major in Biology, Chemistry, Pharmaceutical Engineering or equivalent working experience.
其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)
1. 具有培养基/缓冲液配置，哺乳动物细胞培养或蛋白纯化等GMP知识和相关工作经验者优先；
Knowledge of GMP and relevant work experience in medium/buffer configuration, mammalian cell culture or protein purification is preferable；
2. 具有细胞培养或蛋白纯化工艺研发、GMP生产支持或者项目管理的经验优先；
Experience in cell culture or protein purification process development, GMP production support or project management is preferred;
3. 具有较好的逻辑思维能力，能够独立撰写中英文草案，报告和其他文件；
Good logical thinking ability and is able to independently write draft, report and other documents in English and Chinese;
4. 具有良好的沟通合作能力和团队协调能力；
Good communication and cooperation ability and team coordination ability;
5. 具有较好的多任务处理能力。
Good multi-task capability. Accept appropriate overtime.
2. 工作职责JOB RESPONSIBILITY
1. 与项目团队紧密合作，收集NPI相关信息，制定生产计划及时间表；
Works closely with the project team to collect NPI related information, make production plan and schedule;
2. 组织生产内部会议，并参与外部会议对生产相关部分进行汇报；
Organize internal production meetings and participate in external meetings to report on production-related matters.
3. 协调包括差距分析，生产工艺讨论，生产文件准备等相关的技术转移活动，清楚了解并跟踪技术转移状态；
Coordinates the technology transfer activities including gap analysis, process discussion, production document preparation, etc., to clearly understand and track the technology transfer status;
4. 负责对所指派项目的生产前准备工作包括文件、仪器及物料等进行及时的跟踪、总结和更新；
Responsible for timely tracking, summary and updating of the pre-production preparation of the assigned project including documents, instruments and materials
5. 根据项目需求支持客户来访、PIP和Remote PIP
Support client visits, PIP and remote PIP based on project requirements;
6. 跟踪、协调及管理项目生产过程中所产生的偏差、变更控制、纠正和预防措施以及所指派项目相关的监管发现的反馈；
Tracks, coordinates and manages the feedback of deviation, change control, corrective and preventive actions arising in the project production process and regulatory findings related to the assigned project;
7. 协调MFG内部资源，与项目团队和内部技术人员紧密合作，与生产团队一起努力按时交付项目；Coordinates MFG internal resources, works closely with the project team and internal technical personnel, and works with the production team to deliver the project on time;
8.主导MFG21技术交流和生产总结，促进PD/MFG21技术平台工艺协调的持续提高，优化生产执行过程。
Leads PD/MFG21 technology exchange and MFG production summary, promotes the continuous improvement of process coordination of PD/MFG21 technology platform, and optimizes the production execution process.