职位描述
主要职责:
Responsibilities
1. 负责常规单抗、复杂抗体、融合蛋白等理化检测和方法验证,并成功转移给QC;
Responsible for physicochemical testing and method validation for conventional monoclonal antibodies, complex antibodies, fusion proteins, etc., and for successful method transfer to QC
2. 负责抗体蛋白titer、纯度、电荷、疏水异质性、糖型、工艺杂质等方法的开发、优化或者问题排查,建立方法以支持项目分析检测,包括但不限于液相色谱HPLC/UPLC (SEC, IEX, HIC, Glycan)、毛细管电泳 (CE-SDS, icIEF, CZE) 等方法;
Responsible for developing, optimizing, and troubleshooting analytical methods to assess antibody titer, purity, charge variants, hydrophobic variants, glycan profiles, process-related impurities, and other attributes. Establishes methods to support project analytical testing, including but not limited to HPLC/UPLC methods (PA, SEC, IEX, HIC, RP and Glycan) and capillary electrophoresis methods (CE-SDS, icIEF, and CZE)
3. 负责液相方法色谱峰、电泳方法迁移峰的定性鉴定和表征研究;
Responsible for the qualitative identification and characterization of chromatographic peaks in liquid chromatography methods and migration peaks in electrophoretic methods
4. 负责文件撰写,涉及检测方法标准操作规程、验证文件、项目申报资料等;
Responsible for the preparation of documentation, including standard operating procedures (SOPs) for analytical methods, validation documents, and project registration submission documents
5. 完成上级交办的其他工作。
Complete other tasks assigned by superiors