Job Responsibilities/岗位职责:
1.Be familiar with the application of analytical methods for ADCs, such as DAR, residual free drug, aggregation level, endotoxin, etc.
熟悉ADC质量分析的技术手段,例如DAR、游离药物、聚集体、内毒素检测等;
2.Responsible for the quality analysis and data interpretation of ADC and linker-payload, including SEC, HIC, RP-HPLC, CE-SDS et al. Knowledge of ADC potency evaluation methods, as ELISA, SPR or Linker-payload characterization methods, nuclear magnetic resonance (NMR), mass spectrometry (MS), inductively coupled plasma mass spectrometry (ICP-MS),and gas chromatography (GC), et al. are preferred.
负责ADC和毒素连接子(linker-payload)的质量分析和数据解读,包括:SEC、HIC、RP-HPLC、CE-SDS等。了解ADC的活性评价方法例如:ELISA、SPR 或者Linker-payload的表征手段核磁共振(NMR)、质谱(MS)、电感耦合等离子体质谱(ICP-MS)、气相色谱(GC)等分析方法者优先;
3.Support quality research and analytical method development, validation, and transfer for ADC small molecule intermediates and ADC during process development, IND application, and early clinical stages.
支持ADC小分子中间体和ADC药物在工艺开发、IND申报阶段和早期临床阶段的质量研究和分析方法开发、确认与转移;
4.ADC analysis related trouble-shooting.
解决出现的ADC分析方法的相关问题;
5.Maintain laboratory equipment and ensure compliance with safety, environmental, and quality standards.
维护实验室设备,确保实验操作符合安全、环境和质量标准。
Job Requirements/岗位要求:
1.Master’s degree or higher in organic chemistry, analytical chemistry, biochemistry, or related fields.
研究生及以上学历,有机化学、分析化学、生物化学或相关专业;
2.2+ years for master’s degree holders in ADC intermediate payload-linker small molecule analysis.
研究生2年以上ADC以及ADC中间体毒素连接子小分子分析相关工作经验;
3.Proficiency in analytical techniques such as HPLC、NMR, ICP-MS, GC, and HPLC et al.
熟练掌握HPLC、NMR、ICP-MS、GC、HPLC等分析技术;
4.Familiarity with the development process and quality control of ADC intermediate linker-payload, with a solid foundation in organic and analytical chemistry.
熟悉ADC中间体毒素连接子的开发流程和质量中控,具备扎实的有机化学和分析化学知识基础;
5.Strong English reading and writing skills for literature review and report writing.
具备良好的英语读写能力,能够查阅和撰写英文文献及实验报告;
6.Excellent communication, teamwork, and problem-solving skills, with the ability to handle high-intensity work.
具有较强的沟通能力、团队协作精神和解决问题的能力,能承担高强度工作。