Job Responsibilities 工作职责： 1.Responsible for process development of purification (mAb, BsAb, etc), including but not limited to chromatography, filtration, UFDF, stability studies, etc. 负责纯化（单抗，双抗等）的工艺开发，包括但不限于层析、过滤、超滤透析、稳定性研究等； 2.Conduct process development and process optimization experiment, including resin screening, filter sizing, buffer sizing, DOE, etc. 执行工艺开发和工艺优化实验，包括填料筛选，滤器选型，缓冲液筛选, DOE等； 3.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，并优化和改善工艺，提高效率； 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。 Qualification 任职资格： 1.Master's degree in life Sciences / Chemistry / Pharmacology or bachelor's degree with three years or more experience in protein purification. 生命科学/化学/药学相关专业的硕士或具有三年及以上从事相关蛋白纯化工作经验的本科学历； 2.3+ year of related experience in purification field. 三年及以上从事相关蛋白纯化工作经验； 3.Thorough knowledge and understanding of biopharmaceutical technology, processes. 对生物制药技术、工艺有较深入的知识和认识； 4.Capable of writing detailed reports and summaries and exhibit detail-oriented documentation skills. 擅长撰写各种详细的报告摘要和注重细节的文档报告； 5.Familiarity of computer-based systems. 熟悉电脑操作； 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； 7.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。