Job Responsibilities 工作职责：
1.Responsible for process development of liquid / lyophilization / PFS filling processes, including but not limited to mixing stress, filling speed, pump stress, holding time study etc.
负责液体/冻干/预灌封的灌装工艺开发，包括但不限于搅拌应力、灌装速度、泵应力、保持时间等；
2.According to the process of Sending Unit, complete process transfer and scale-up at different scale at different site, and transfer the process to the manufacturing department finally.
按照转移方转移的工艺，完成不同厂区不同规模的工艺转移和放大，并最终将工艺转移到生产部门；
3.Responsible for PC/PV of liquid/lyophilization/PFS filling processes, including to SDM, PC/PPQ protocol, DOE, E/L assessment, sterile filtration validation, etc.
负责液体/冻干/预灌封的灌装工艺表征和工艺验证，包括但不限于缩小模型，工艺表征/工艺性能确认方案，实验设计，可提取物和可浸出物评估，无菌过滤验证等；
4.Responsible for managing technical documents including operating procedures, protocols, reports, risk assessments, laboratory investigations, etc.
负责管理技术文件包括操作规程，方案，报告，风险评估，实验室调查报告等；
5.Responsible for data analysis, data review and trend analysis.
负责数据分析，数据审核和趋势分析；
6.Track the DP daily production and provide technology support for production of MFG, assist in troubleshooting and solving problems.
跟踪DP的日常生产，并对MFG的生产提供技术支持，并协助排查与解决问题；
7.According to the production process, review the relevant GMP production documents.
根据生产工艺，审阅相关GMP生产文件；
8.Summary change control of owner each project, Optimize and improve processes, improve efficiency.
总结每个项目的变更控制，并优化和改善工艺，提高效率；
9.Together with FD, pay attention to the information of related review and application regulations.
与FD一起关注相关评审和法规相关的信息；
10.Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
与公司内外各部门进行有效沟通，顺利推动项目按时完成；
11.Other work arranged by superior leaders.
上级领导安排的其他工作。