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。
Qualification 任职资格：
1.Master or PhD degree in Analytical Chemistry, Biology, Biophysics, life sciences or related disciplines.
硕士或博士学历，分析化学、生物学、生物物理、生命科学或相关专业；
2.Analytical and formulation development experience in biopharmaceutical industry is preferred.
如具有生物制药行业的分析与处方开发相关工作经验者优先考虑；
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.
熟悉蛋白生物药分析仪器，包括HPLC、毛细管电泳、示差扫描热卡计、动态光散射、MFI/FlowCam、UNcle/NT PR、渗透压仪、不溶性微粒检测、卡式水分仪等；
4.Understand ICH，ChP regulations and guidelines.
了解ICH, ChP法规和指导原则；
5.Excellent oral and written communication skills in English.
良好的英文口语和书面沟通能力。