Job Responsibilities 工作職責： 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，例如單克隆抗體，蛋白質和疫苗； 2.Design and execute formulation development activities (including liquid and lyophilization formulations). Have PFS development experience is a plus. 設計和執行配方開發活動（包括液體和凍干制劑）, 有預充針(PFS)經驗尤佳； 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，以確定穩定性，并應用此信息開發配方。 通過應用各種生物物理和生化技術來實現，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. 具有多種分析技術的經驗，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. 負責起草技術文件包括操作規程，草案，報告，風險評估，實驗室調查報告等； 6.Design and Conduct the stability study, including long-term, accelerated, forced degradation and in-use stability tests. 設計及執行穩定性試驗, 包括長期穩定性、加速穩定性、強制降解、臨床穩定性研究； 7.Write and review IND, BLA and other regulatory documents. 撰寫和審核IND,BLA和其他法規文件； 8.Assist formulation development work and response to clients. 響應客戶的提案要求，協助制劑開發工作； 9.Perform analytical data analysis, data review and trending analysis. 負責數據分析，數據審核和趨勢分析； 10.Other work arranged by superior leaders. 上級領導安排的其他工作。