岗位职责:
1、参与MST上游生产相关生产设备的URS的准备
Participation in the preparation relevant URSs in MST USP Production
2、参与MST上游生产设备的FAT、SAT、IQ、OQ、PQ
Participation in FAT、SAT、IQ、OQ、PQ of relevant URSs in MST USP Production
3、准备MST上游生产设备SOP、PQ文件
To be responsible for preparation the SOP/PQ files of related equipment
4、准备MST上游生产相关的文件
To be responsible for preparation the relevant files(SOP) in MST USP Production
5、按工艺规程进行上游生产操作
To be responsible for MST upstream production operation according to procedure
6、上游生产的协调、现场管理及培训工作
To be responsible for management of MST production site, the training, and coordination of USP production.
任职要求:
1、本科或以上学历,药学,生物学或化学专业。
Bachelor or above degree in Pharmacy, Biology or Chemistry.
2、熟悉MST 上游细胞培养技术和工艺放大,包括细胞复苏,扩增培养,收获及物料澄清,至少能熟练操作一种反应器。
To be familiar with upstream cell culture techniques and scale up of Mab in PD, including cell thaw, cell expansion, harvest and clarification, can skilled operate at least one kind of bio-reactor.
3、生物行业5年以上制药经验
At least five years of practical experience in Bio-pharmaceutical industry
4、英语水平良好,会熟练使用电脑
Good English at reading & writing and computer skills
职位福利:节日福利、周末双休、五险一金、股票期权、交通补助、带薪年假、补充医疗保险、定期体检