岗位职责：



负责下游纯化工艺开发平台的搭建；

负责下游纯化工艺开发，包括小试和中试工艺开发；

负责下游纯化工艺表征研究;

负责200L规模的IND中试纯化生产；

负责研发到生产的下游技术转移，并提供GMP生产现场技术支持;

负责下游纯化相关技术报告的撰写；

负责申报资料纯化部分资料的撰写；

完成领导安排的其他任务。





任职资格：



硕士及以上学历，生物工程、生物技术及相关专业；

1年以上蛋白质纯化工艺开发工作经验；

精通抗体下游工艺开发，包括小试和中试。有纯化工艺表征研究经验者优先；

2个以上IND项目申报经验；

良好的组织、协调、沟通、计划和执行能力；

具有高度的责任感、团队合作和敬业精神；

英语流利优先。









Responsibility：



Responsible for the establishment of purification process development platform.

Responsible for downstream purification process development, including lab and pilot scale process development.

Responsible for characterization study of purification process.

Responsible for non-GMP 200L purification production.

Responsible for technology transfer from PD to production and provide technical support for GMP production site.

Responsible for writing downstream technology reports.

Responsible for writing purification related files for IND.

Complete other related task assigned by leader.





Qualification:



1. Master degree or above, major in bioengineering, biotechnology and related fields.



2. Above 1 year of purification development experience.



3. Skilled in downstream antibody technology development including lab and pilot scale development; experience in downstream process characterization study is preferred.



4. Complete more than two IND project.

5. Good organization, coordination, communication, planning and execution skills.

6. Strong sense of responsibility and teamwork.

7. Fluency in English is preferred.