职位描述
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职位描述:
responsibilities:
1.responsible for upstream process technology transfer, engineering scale-up,
2.responsible for process optimization from bench to large scale for a number of production processes using mammalian cell culture technology.
3.lead a group of scientist, associates, technical operators to conduct mammalian cell culture including cho, hek293, ns0, and other cell lines in producing monoclonal antibodies, cytokines, igg fusion proteins.
4.train junior staffs in technical and gmp compliance.
5.the group will accept lab scale process through technology transfer and scale-up the process to production scale with optimization in large scale production.
6.the group will conduct production harvest to support downstream production.
request:
1.minimum 5 years biopharmaceutical industrial experiences after ph.d. training in related fields of biochemical engineering, chemical engineering, biochemistry, cell biology, industrial fermentation, and/or biological sciences. must have cgmp experiences in biologics.
2.previous leadership in upstream biological production is appreciated.
3.previous experiences in international biopharmaceutical industry is a plus.excellent communication skill both in chinese and in english is required.
主要职责:
1.负责上游的工艺技术转移、工程放大;
2.负责使用到脯乳动物细胞培养技术的工艺优化(从实验室研发到大规模生产);
3.负责领导团队(包括:科学家、助理及技术操作人员等)进行哺乳动物细胞培养,包括cho, hek293, ns0, 和其它细胞株在生产单克隆抗体、细胞因子及igg融合蛋白
4.依照gmp的相关要求及标准对初级员工的进行技术培训及其他培训;
5. 确保团队通过技术转移和工程放大接收并熟悉实验室规模的操作流程,并实现大规模生产的工艺优化;
6. 带领团队进行产品收集,用以支持下游生产的相关工作;
具体要求:
1. 生物工程、化学工程、生物化学、细胞生物学、工程发酵等生物相关专业博士或同等学历;需5年以上生物制药企业相关工作经历;
2. 必须具备生物制剂cgmp相关工作经验;熟知cgmp相关知识及要求标准;
3. 拥有生物制药生产上游管理经验者优先;拥有国际生物制药企业相关工作经验者优先;
4. 具有流利的英语口语和读写能力。