[武汉]鼎康（武汉）生物医药有限公司

岗位描述：
? Participate in protein physicochemical analysis（including purity testing（by HPLC,CE）, concentration testing，etc）and biochemical analysis（including Residual HCP, HCDNA, ProteinA testing, etc）;
参与蛋白理化分析（包括用HPLC,CE进行纯度检测，浓度检测等）和生化分析（包括残留HCP, HCDNA, Protein A 等）；
? Participate in analytical method development, qualification and method transfer of physicochemical and biochemical testing;
参与理化和生化检测的分析方法开发，确认和方法转移；
?  Perform routine analysis of MSAT as well as other non-GMP samples, including in-process according to SOPs;
根据SOP执行MSAT 和其它non-GMP 样品的常规分析，包括中控样品等；
?  Provide analytical technical support to cell culture ,  purification and formulation groups in process development trouble shooting, tech transfer and scale-up activities;
对细胞培养组、下游纯化组和制剂组的工艺开发问题解决，技术转移及放大提供分析技术支持；
?  Perform technical writing assignments such as SOPs, protocols, reports,  risk assessments, laboratory investigations, 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；
? Write and review IND, BLA and other regulatory documents;
撰写和审核IND,BLA和其他法规文件；
?  Perform analytical data analysis ，data review and trending analysis;
负责数据分析，数据审核和趋势分析；
?  Other work arranged by superior leaders.
上级领导安排的其他工作。