Job Responsibilities/崗位職責(zé):
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(zhì)量分析的技術(shù)手段,例如DAR、游離藥物、聚集體、內(nèi)毒素檢測(cè)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(fù)責(zé)ADC和毒素連接子(linker-payload)的質(zhì)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(píng)價(jià)方法例如:ELISA、SPR 或者Linker-payload的表征手段核磁共振(NMR)、質(zhì)譜(MS)、電感耦合等離子體質(zhì)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(kāi)發(fā)、IND申報(bào)階段和早期臨床階段的質(zhì)量研究和分析方法開(kāi)發(fā)、確認(rèn)與轉(zhuǎn)移;
4.ADC analysis related trouble-shooting.
解決出現(xiàn)的ADC分析方法的相關(guān)問(wèn)題;
5.Maintain laboratory equipment and ensure compliance with safety, environmental, and quality standards.
維護(hù)實(shí)驗(yàn)室設(shè)備,確保實(shí)驗(yàn)操作符合安全、環(huán)境和質(zhì)量標(biāo)準(zhǔn)。
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(xué)歷,有機(jī)化學(xué)、分析化學(xué)、生物化學(xué)或相關(guān)專(zhuān)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(guān)工作經(jīng)驗(yàn);
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(shù);
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(kāi)發(fā)流程和質(zhì)量中控,具備扎實(shí)的有機(jī)化學(xué)和分析化學(xué)知識(shí)基礎(chǔ);
5.Strong English reading and writing skills for literature review and report writing.
具備良好的英語(yǔ)讀寫(xiě)能力,能夠查閱和撰寫(xiě)英文文獻(xiàn)及實(shí)驗(yàn)報(bào)告;
6.Excellent communication, teamwork, and problem-solving skills, with the ability to handle high-intensity work.
具有較強(qiáng)的溝通能力、團(tuán)隊(duì)協(xié)作精神和解決問(wèn)題的能力,能承擔(dān)高強(qiáng)度工作。