理化分析研究员

Job Responsibilities 工作职责：
1. Participate in protein physicochemical analysis, including HPLC and CE related analytical methods，protein content by UV, etc.
参与蛋白理化分析，包括HPLC有关分析方法，毛细管电泳有关分析方法，UV蛋白含量检测等；
2. Participate in analytical method development, qualification and method transfer.
参与理化检测的分析方法开发，确认和方法转移；
3. 3Per SOPs, perform routine analysis of process development samples from MSAT and other non-GMP samples, including in-process samples.
根据SOP执行MSAT部门工艺开发样品和其它non-GMP 样品的常规分析，包括中控样品等；
4. Provide analytical technical support to upstream and downstream process development groups during process development and troubleshooting. Support formulation development, tech transfer and scale-up activities.
对上下游的工艺开发提供分析支持并协助排查与解决问题，对制剂开发、技术转移、放大工艺提供分析技术支持；
5. Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
负责起草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；
6. Conduct the stability study, including long-term, accelerated and forced degradation stability tests.
执行稳定性实验, 包括长期稳定性、加速稳定性、强制降解研究；
7. Write and review IND, BLA and other regulatory documents.
撰写和审核IND,BLA和其他法规文件；
8. Perform analytical data analysis, data review and trending analysis.
负责数据分析，数据审核和趋势分析；
9. Other work arranged by superior leaders.
上级领导安排的其他工作。