制剂开发研究员

Job Responsibilities 工作职责：
1.Participate in development parenteral formulations for biotherapeutics modalities such as monoclonal antibodies, proteins and vaccines.
参与生物药的注射剂处方开发，例如单克隆抗体，蛋白质和疫苗；
2.Design and execute formulation development activities (including liquid and lyophilization formulations). Have PFS development experience is a plus.
设计和执行配方开发活动（包括液体和冻干制剂）, 有预充针(PFS)经验尤佳；
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.
对候选分子进行快速全面的表征，以确定稳定性，并应用此信息开发配方。 通过应用各种生物物理和生化技术来实现，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.
具有多种分析技术的经验，例如SEC-HPLC、IEX-HPLC、capillary electrophoresis (CE) 、HIAC、渗透压仪、 浊度计、Karl Fischer and microVISC；
5.Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
负责起草技术文件包括操作规程，草案，报告，风险评估，实验室调查报告等；
6.Design and Conduct the stability study, including long-term, accelerated, forced degradation and in-use stability tests.
设计及执行稳定性试验, 包括长期稳定性、加速稳定性、强制降解、临床稳定性研究；
7.Write and review IND, BLA and other regulatory documents.
撰写和审核IND,BLA和其他法规文件；
8.Assist formulation development work and response to clients.
响应客户的提案要求，协助制剂开发工作；
9.Perform analytical data analysis, data review and trending analysis.
负责数据分析，数据审核和趋势分析；
10.Other work arranged by superior leaders.
上级领导安排的其他工作。