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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(yàn)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(jìn)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(shí)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(yàn)，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(fù)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(shí)驗(yàn)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(yàn), 包括長期穩(wěn)定性、加速穩(wěn)定性、強(qiáng)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(fù)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。