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. Compatibility evaluation of CCS.
密封系统的相容性评估
3.Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc.;
负责管理技术文件包括操作规程，草案，报告，风险评估，实验室调查报告等；
4. Responsible for data analysis, data review and trend analysis;
负责数据分析，数据审核和趋势分析；
5. Provide technology support for production of MFG, assist in troubleshooting and solving problems;
对MFG的生产提供技术支持，并协助排查与解决问题；
6. 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；
7. Summary change control of owner each project, Optimize and improve processes, improve efficiency;
总结每个项目的变更控制，并优化和提高生产效率；
8.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；
9. Other work arranged by superior leaders.
上级领导安排的其他工作。


Job Requirements/岗位要求
1.Master’s Degree in Life Sciences/Chemistry/Pharmacology or Bachelor’s Degree in Life Sciences/Chemistry/Pharmacology and 5+ year of related experience in liquid/lyophilization/PFS filling process;
生命科学/化学/药学相关专业的硕士或具有五年及以上从事相关液体/冻干/预灌封的灌装工艺工作经验的本科学历；
2. Thorough knowledge and understanding of liquid/lyophilization/PFS processes;
对液体/冻干/预灌封的工艺有较深入的知识和认识；
3. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills;
擅长撰写各种报告摘要和文档报告；
4. Familiarity of computer-based systems;
熟悉电脑操作；
5. Must be flexible to work on any shift (day, night, weekend);
适合弹性的工作时间，愿意配合加班；
6.Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory.
良好的中英文读写和沟通能力，可与其他部门进行沟通解决问题。