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更新于 5月14日

表征分析研究員

6000-9000元
  • 武漢江夏區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

生化分析藥理毒理分析藥品穩(wěn)定性分析藥品質(zhì)量分析生物藥
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)上下游的工藝開發(fā)提供分析支持并協(xié)助排查與解決問題,對(duì)制劑開發(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部門工藝開發(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發(fā),確認(rèn),驗(yàn)證和轉(zhuǎn)移過程; 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. 良好的英文口語和書面溝通能力。

工作地點(diǎn)

江夏區(qū)湖北省武漢市東湖開發(fā)區(qū)高新二路388號(hào)

職位發(fā)布者

Krystal Wang/hr

立即溝通
公司Logo鼎康(武漢)生物醫(yī)藥有限公司
鼎康生物是一家領(lǐng)先的CDMO公司,可提供一站式的CMC解決方案,支持從早期藥物開發(fā)到后期臨床研究和商業(yè)化cGMP生產(chǎn)。鼎康引進(jìn)了全球首個(gè)模塊化生物制藥工廠Kubio;為客戶開發(fā)的多個(gè)產(chǎn)品已經(jīng)在全球20多個(gè)國家進(jìn)行臨床試驗(yàn)。在不久的將來,鼎康生物總產(chǎn)能將超過140,000L。我們承諾通過技術(shù)和生產(chǎn)創(chuàng)新,使全球患者都能負(fù)擔(dān)得起具有國際標(biāo)準(zhǔn)的生物藥物,提高治療水平以改善人類健康。
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