更新于 1月7日

制劑開發(fā)研究員

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

職位描述

蛋白制劑固體制劑半固體制劑液體制劑
Job Responsibilities 工作職責(zé):
1.Participate in development parenteral formulations for biotherapeutics modalities such as monoclonal antibodies, proteins and vaccines.
參與生物藥的注射劑處方開發(fā),例如單克隆抗體,蛋白質(zhì)和疫苗;
2.Design and execute formulation development activities (including liquid and lyophilization formulations). Have PFS development experience is a plus.
設(shè)計和執(zhí)行配方開發(fā)活動(包括液體和凍干制劑), 有預(yù)充針(PFS)經(jīng)驗尤佳;
3.Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and applying this information to develop the formulation. This will be achieved by applying various biophysical and biochemical techniques such as DSC, nanoDSF(NT PR or UNcle), DLS, SLS and FlowCam/MFI.
對候選分子進行快速全面的表征,以確定穩(wěn)定性,并應(yīng)用此信息開發(fā)配方。 通過應(yīng)用各種生物物理和生化技術(shù)來實現(xiàn),例如DSC, nanoDSF(NT PR or UNcle), DLS, SLS 和FlowCam/MFI;
4.Experience with various analytical techniques like SEC-HPLC, IEX-HPLC, capillary electrophoresis (CE), HIAC, osmometer, turbidity, Karl Fischer and microVISC.
具有多種分析技術(shù)的經(jīng)驗,例如SEC-HPLC、IEX-HPLC、capillary electrophoresis (CE) 、HIAC、滲透壓儀、 濁度計、Karl Fischer and microVISC;
5.Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
負責(zé)起草技術(shù)文件包括操作規(guī)程,草案,報告,風(fēng)險評估,實驗室調(diào)查報告等;
6.Design and Conduct the stability study, including long-term, accelerated, forced degradation and in-use stability tests.
設(shè)計及執(zhí)行穩(wěn)定性試驗, 包括長期穩(wěn)定性、加速穩(wěn)定性、強制降解、臨床穩(wěn)定性研究;
7.Write and review IND, BLA and other regulatory documents.
撰寫和審核IND,BLA和其他法規(guī)文件;
8.Assist formulation development work and response to clients.
響應(yīng)客戶的提案要求,協(xié)助制劑開發(fā)工作;
9.Perform analytical data analysis, data review and trending analysis.
負責(zé)數(shù)據(jù)分析,數(shù)據(jù)審核和趨勢分析;
10.Other work arranged by superior leaders.
上級領(lǐng)導(dǎo)安排的其他工作。


Qualification 任職資格:
1.Master or PhD degree in Analytical Chemistry, Biology, Biophysics, life sciences or related disciplines.
碩士或博士學(xué)歷,分析化學(xué)、生物學(xué)、生物物理、生命科學(xué)或相關(guān)專業(yè);
2.Analytical and formulation development experience in biopharmaceutical industry is preferred.
如具有生物制藥行業(yè)的分析與處方開發(fā)相關(guān)工作經(jīng)驗者優(yōu)先考慮;
3.Be familiar with analytical methods for protein/biologics analysis, such as HPLC, CE, DSC, DLS, MFI/Flowcam, UNcle/NT PR, osmometer, HIAC, Karl Fischer and etc.
熟悉蛋白生物藥分析儀器,包括HPLC、毛細管電泳、示差掃描熱卡計、動態(tài)光散射、MFI/FlowCam、UNcle/NT PR、滲透壓儀、不溶性微粒檢測、卡式水分儀等;
4.Understand ICH,ChP regulations and guidelines.
了解ICH, ChP法規(guī)和指導(dǎo)原則;
5.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

湖北省武漢市東湖開發(fā)區(qū)高新二路388號

職位發(fā)布者

Krystal Wang/hr

立即溝通
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