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。

Qualification 任职资格：
1. Be familiar with equipment for protein/biologics analysis, such as UV spectrometer, SoloVPE, HPLC, CE, MALS, SPR, CD, DSC, HIAC, Karl Fischer and etc.
熟悉蛋白生物药分析仪器，包括UV分光仪、SoloVPE、HPLC、毛细管电泳、多角度静态光散射、表面等离子共振、圆二色光谱、示差热卡计、不溶性微粒检测、卡式水分仪等；
2. Be familiar with analytical method development, qualification, validation and method transfer of physicochemical tests.
熟悉理化分析的方法开发，确认，验证和转移过程；
3. Understand ICH，ChP regulations and guidelines.
了解ICH, ChP法规和指导原则；
4. Excellent oral and written communication skills in English.
良好的英文口语和书面沟通能力；
5. Master degree or above, in chemistry, biology, life sciences or related disciplines, candidates with a bachelor's degree with relevant experience are also eligible.
硕士及以上学历，化学、生物学、生命科学或相关专业，本科学历有相关经验的候选人也可；
6. Analytical experience in biopharmaceutical industry is preferred.
具有生物制药行业的分析相关工作经验者优先考虑。