Full Time

DS Purification supervisor

Posted 1 month ago
Application ends: November 11, 2021
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Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

Education/ Professional Qualification

学历/专业资格

Ÿ Bachelor or above degree in Pharmaceutical, Chemical, Microbiological or related field.

药学、化学、微生物学或相关学科学士或以上学位。

Technical/Skills Required

技术/技能训练

Ÿ Familiar with the regulatory requirement of CFDA cGMP、EU cGMP、PIC/S cGMP and FDA cGMP.

熟悉CFDA cGMP、EU cGMP、PIC/S cGMP及FDA cGMP的要求。

Ÿ Familiar with Downstream Purification techniques and scale up of process, including Chromatography, Viral inactivation, Viral filtration, UF/DF, etc.

熟悉下游纯化技术和工艺放大,包括层析,病毒灭活,除病毒过滤,超滤/透析,等。

Ÿ Strongly address, investigate and solve ability.

具有较强的处理、分析和解决问题的能力。

Working Experience

工作经验

Ÿ At least five years of practical experience in Bio-pharmaceutical industry

医药行业5年以上生物制药验证经验

Language, Computer Literacy, Office Software, etc.

语言能力,电脑知识,办公软件等

Ÿ Good English and computer skill

英语水平良好,会熟练使用电脑

Others

其他

Ÿ Proactive and dedicated with a strong sense of responsibility and integrity;

积极敬业、主动进取、责任心强、正直向上;

Ÿ Competent in organization and coordination, team leadership, analytical skills and problem solving;

有较强的组织协调能力、良好的团队领导力、较强的分析和解决问题的能力

Ÿ Good communication skills

具有良好的沟通表达能力;

Qualification Required

Ÿ Lead and participate in the activities include URS/FAT/SAT/IQ/OQ of DS upstream department

组织并参与上游生产设备的URS、FAT、SAT、IQ、OQ

Ÿ Lead and participate in documents preparing, revising, and management of DS upstream department

组织并参与准备上游生产相关文件起草,修订,管理等

Ÿ Lead and participate in validation jobs of of DS upstream department

组织并参与准备上游生产的验证工作

Ÿ Make production according to the manufacturing plan, include documents preparation, material preparation, buffer preparation, process operation, and so on.

按照生产计划组织开展工艺生产活动,包括文件准备、物料准备、溶液准备、工艺操作等相关活动。

Ÿ Upstream production cooperation, site management and training.

上游生产的协调、现场管理及员工培训工作

Ÿ Any other assignment as is determined by supervisor.

完成上级安排的其他工作。

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