Job Responsibilities 工作職責(zé):
1.Participate in protein LC-MS characterization, including molecular weight, peptide mapping sequence coverage, disulfide linkage, glycosylation site, and post-translational modifications (PTM).
參與蛋白質(zhì)譜結(jié)構(gòu)表征,包括分子量、肽圖序列覆蓋率、二硫鍵、糖基化位點(diǎn)和翻譯后修飾等;
2.Participate in characterization and analytical method development.
參與表征和分析方法開(kāi)發(fā);
3.Provide analytical technical support to upstream/downstream process development groups during process development and trouble shooting. Support formulation development, tech transfer and scale-up activities.
對(duì)上下游的工藝開(kāi)發(fā)提供分析支持并協(xié)助排查與解決問(wèn)題,對(duì)制劑開(kāi)發(fā)、技術(shù)轉(zhuǎn)移、放大工藝提供分析技術(shù)支持;
4.Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
負(fù)責(zé)起草技術(shù)文件包括操作規(guī)程,方案,報(bào)告,風(fēng)險(xiǎn)評(píng)估,實(shí)驗(yàn)室調(diào)查報(bào)告等;
5.Per SOPs, perform routine analysis of samples of process development from PD and other non-GMP samples, including in-process samples.
根據(jù)SOP執(zhí)行PD部門(mén)工藝開(kāi)發(fā)樣品和其它non-GMP 樣品的常規(guī)分析,包括中控樣品等;
6.Perform analytical data analysis, data review and trending analysis.
負(fù)責(zé)數(shù)據(jù)分析,數(shù)據(jù)審核和趨勢(shì)分析;
7.Other work arranged by superior leaders.
上級(jí)領(lǐng)導(dǎo)安排的其他工作。
Qualification 任職資格:
1.Bachelor degree or above in chemistry, biology, life sciences or related disciplines.
本科及以上學(xué)歷,化學(xué)、生物學(xué)、生命科學(xué)或相關(guān)專(zhuān)業(yè);
2.Analytical experience in biopharmaceutical industry is preferred.
如具有生物制藥行業(yè)的分析相關(guān)工作經(jīng)驗(yàn)者優(yōu)先考慮;
3.HPLC operation experience was necessary, practical operation experience in Waters-QTOF or Thermo Orbitrap mass spectrometry, and familiar with the structure of protein biopharmaceuticals is preferred.
必須具備HPLC操作經(jīng)驗(yàn),有Waters-QTOF或者Thermo Orbitrap質(zhì)譜實(shí)際操作經(jīng)驗(yàn)、熟悉蛋白生物藥結(jié)構(gòu)者為佳;
4.Be familiar with equipment for protein/biologics analysis, such as UV spe2ctrometer, HPLC, UPLC, CE and etc.
熟悉蛋白生物藥分析儀器,包括UV分光儀、HPLC、UPLC、毛細(xì)管電泳儀等;
5.Be familiar with analytical method development, qualification, validation and method transfer of physicochemical tests.
熟悉理化分析的方法開(kāi)發(fā),確認(rèn),驗(yàn)證和轉(zhuǎn)移過(guò)程;
6.Understand ICH,ChP regulations and guidelines.
了解ICH, ChP法規(guī)和指導(dǎo)原則;
7.Excellent oral and written communication skills in English.
良好的英文口語(yǔ)和書(shū)面溝通能力。