Job Responsibilities/崗位職責:
1.Be familiar with the application of analytical methods for ADCs, such as DAR, residual free drug, aggregation level, endotoxin, etc.
熟悉ADC質量分析的技術手段,例如DAR、游離藥物、聚集體、內(nèi)毒素檢測等;
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.
負責ADC和毒素連接子(linker-payload)的質量分析和數(shù)據(jù)解讀,包括:SEC、HIC、RP-HPLC、CE-SDS等。了解ADC的活性評價方法例如:ELISA、SPR 或者Linker-payload的表征手段核磁共振(NMR)、質譜(MS)、電感耦合等離子體質譜(ICP-MS)、氣相色譜(GC)等分析方法者優(yōu)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小分子中間體和ADC藥物在工藝開發(fā)、IND申報階段和早期臨床階段的質量研究和分析方法開發(fā)、確認與轉移;
4.ADC analysis related trouble-shooting.
解決出現(xiàn)的ADC分析方法的相關問題;
5.Maintain laboratory equipment and ensure compliance with safety, environmental, and quality standards.
維護實驗室設備,確保實驗操作符合安全、環(huán)境和質量標準。
Job Requirements/崗位要求:
1.Master’s degree or higher in organic chemistry, analytical chemistry, biochemistry, or related fields.
研究生及以上學歷,有機化學、分析化學、生物化學或相關專業(yè);
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中間體毒素連接子小分子分析相關工作經(jīng)驗;
3.Proficiency in analytical techniques such as HPLC、NMR, ICP-MS, GC, and HPLC et al.
熟練掌握HPLC、NMR、ICP-MS、GC、HPLC等分析技術;
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中間體毒素連接子的開發(fā)流程和質量中控,具備扎實的有機化學和分析化學知識基礎;
5.Strong English reading and writing skills for literature review and report writing.
具備良好的英語讀寫能力,能夠查閱和撰寫英文文獻及實驗報告;
6.Excellent communication, teamwork, and problem-solving skills, with the ability to handle high-intensity work.
具有較強的溝通能力、團隊協(xié)作精神和解決問題的能力,能承擔高強度工作。