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工艺开发和技术转移总监/高级总监

发布时间:2017-07-18 
职位职能:  生物工程/生物制药  医药技术研发管理人员

职位描述:
★    工艺开发和技术转移总监/高级总监
Director or Senior Director, Process Development and Technology Transfer

Responsibilities:
The individual is responsible for upstream and downstream process development, technology transfer, engineering scale-up, process optimization from bench to large scale for a number of production processes. The individual will lead a department including several groups of scientist, associates, and technical operators to conduct upstream mammalian cell culture, E. coli fermentation, viral vector production and downstream recovery, purification, formulation and fill finish. The individual will be responsible for budgeting, establishing standard operation procedures, implementation of GMP manufacturing for IND submission. Supporting regulatory affair department and Manufacturing department.

Request:
Minimum 10 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. Previous leadership in upstream and downstream biological manufacturing is appreciated. 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.负责生物制药上、下游的工艺开发、技术转移、工艺放大以及从实验室到规模化生产的工艺优化。
2.负责领导部门内多个团队(包括:科学家、助理及技术操作人员等)进行上游哺乳动物细胞培养,大肠杆菌发酵、病毒载体的生产以及下游的回收、净化、 制备和填充完成。
3.负责部门内预算的管理,建立标准化操作流程,支持与配合药品报批部门和生产部门的相关工作。

具体要求:
1.生物工程、化学工程、生物化学、细胞生物学、工程发酵或生物科学相关专业博士毕业,至少10年以上生物制药企业的相关工作经验。
2.必须具有生物制剂的cGMP相关经验,精通cGMP相关知识及要求标准;
3.拥有生物制药生产上下游管理经验者优先;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。

上班地址:
滨海新区中新生态城中天大道1620号研发大厦

杰科(天津)生物医药有限公司 pk10techchasse.com版权所有

地址:中国天津滨海新区中新天津生态城中天大道1620号研发大厦12层

技术支持:维程互联

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