职位描述
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职位描述:
responsibilities:
the individual is responsible for downstream process technology transfer, engineering scale-up, process optimization from bench to large scale for a number of production processes using e. coli and/or mammalian cell culture technology. the individual will lead a group of scientist, associates, technical operators to conduct purification of recombinant proteins, or monoclonal antibodies, or immunotoxins, or viral vectors. the individual will train junior staffs in technical skills and gmp compliance. the group will accept lab scale process through technology transfer and scale-up the process to production scale with optimization in large scale production. the group will support analytical development and product characterization.
request:
minimum 5 years biopharmaceutical industrial experiences after ph.d. training in related fields of biochemical engineering, chemical engineering, protein engineering, biochemistry, and/or biological sciences. must have cgmp experiences in biologics. previous leadership in downstream biological production 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. 负责下游的技术转移、工程放大以及使用到大肠杆菌和/或哺乳动物细胞培养技术的多项生产工艺的工艺优化(从实验室到大规模生产)
2. 负责带领团队(包括:科学家、助理及技术操作人员等)对重组蛋白、单克隆抗体、抗毒素或病毒载体进行纯化;
3. 负责依照gmp的相关要求及标准对初级员工的进行相关的技术培训及其他培训;
4. 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;
5. 确保团队能够支持分析开发及产品特性的鉴定;
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。