Job Responsibilities 工作职责
1. Independent completion of biological activity screening and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target ligand binding experiments, and biological activity experiments based on specific cell biological mechanisms.
独立完成抗体药物分析的生物活性筛选评估实验，包括但不限于各类生物分子靶点结合能力实验，以特异细胞生物机理的生物活性实验；
2. Participate in the bioassay development, including ADCC, ADCP, CDC, binding ELISA and cell-based assays.
参与活性分析方法开发，包括ADCC、ADCP、CDC、ELISA结合活性、细胞生物活性试验等；
3. Perform routine analysis of samples of process development from MSAT and other non-GMP samples, including in-process samples.
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. Participate in the method development, method optimization and method qualification of protein drug analytical method; implement the preparation of SOP and method validation reports.
参与蛋白药物检测方法开发及验证; 执行SOP与方法学验证报告的撰写；
5. 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；
6. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
针对关键问题与跨模块团队合作, 有效沟通, 并提出解决方案；
7. 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；
8. Other work arranged by superior leaders.
上级领导安排的其他工作。

Qualification 任职资格
1. Master or PhD degree, major in cell biology, molecular biology or life sciences.
硕士或博士学历，細胞生物、分子生物学、生命科学相关专业；
2. With 2 years or more of experience in ligand binding and cell-based assay development. Perform bioassays independently. With R&D experience is a plus.
具有2年及以上结合活性与细胞活性开发经验，能独立完成生物活性检验, 具备研发经验尤佳；
3. Hands-on experience in instrument analysis, familiar with various analysis techniques (e.g. cell-based potency assay, binding ELISA, MSD, BLI, neutralization assay, FACS, HTRF, ADCC and CDC), and master various biochemical test methods, confirmation, verification and transfer processes.
具有仪器分析的实际操作经验，熟悉各种分析技术(细胞活性分析、ELISA结合活性、MSD、BLI、中和试验、FACS、HTRF、ADCC和CDC)，对上下游工作流程熟悉，并熟练掌握各种生化测试方法、确认、验证和转移过程；
4. Understand ICH, USP, ChP regulations and guidelines.
了解ICH, USP, ChP法规和指导原则；
5. Excellent oral and written communication skills in English.
良好的英文读写和沟通能力。