职位描述:

-设计并开展大分子蛋白药物的理化性质研究，如抗体、融合蛋白、ADC等。

Design and perform analytical analysis for biologics projects such as antibody, fusion protein and ADC, to support physicochemical properties；

-进行蛋白药物分析和表征方法开发，产生高质量数据，并对数据进行分析，结论和撰写报告，对分析方法进行确认和验证。

Develop analytical and characterization method to generate high quality data, perform data analysis, make conclusion and reports. Perform analytical method qualification and validation.

-支持细胞系开发和工艺开发高通量样品分析；支持工艺放大和中试阶段QC工作，进行早期临床稳定性研究，以及与生产部门的方法转移工作。

Analytical screening to support cell line development and process development. Analytical support for scale-up and pilot QC test. Conduct early clinical stability studies as well as method transfer with the manufacturing department.

-能独立完成SOP，研究方案和报告等的撰写。

-Draft SOP, study protocol and study report independently.

任职条件:

-分子生物学、生物化学、生物技术或相关学科的本科或硕士，2~5年在制药或生物技术公司工作经验。

-Bachelor or Master’s degree in molecular biology, biochemistry, biotechnology or related background with 2-5 years of industrial experience.

-熟练掌握和精通大分子分析技术，包括HPLC, UPLC, LC-MS, CGE, iCIEF, CZE, ELISA等。

-Hands-on experiences in analytical development for biologics large molecule, including but not limited to HPLC, UPLC, LC-MS, CGE, iCIEF, CZE, ELISA.

-有生物制药公司、GLP/GMP工作经验，有良好的QC培训经历者优先。

-Experience in biotechnologies or GLP/GMP workshop, well trained with QC’s basic operation sence would be a plus.

-文献阅读和解决问题的能力，良好的沟通和合作能力，较强的执行力。

- Literature search to solve problem as needed ; good communication and collaboration skills；excellent execution ability;