Full Time

DS Purification Manager

Posted 1 month ago
Application ends: November 10, 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

 Bachelor or above degree in Pharmaceutical, Chemical, biological or related field.

药学、化学、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 NMPA cGMP、EU cGMP、PIC/S and FDA cGMP;

熟悉NMPA cGMP、EU cGMP、PIC/S 及FDA cGMP的要求;

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

熟悉抗体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 5 years BIO manufacturing experiences and at least 2 years supervisory/managerial roles.

医药行业5年以上生物制药生产经验,2年以上生产主管经验。

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 validation activities include URS/FAT/SAT/IQ/OQ/PQ of DS downstream Equipment;

组织并参与下游生产设备的URS、FAT、SAT、IQ、OQ、PQ;

Ÿ Lead and participate in GMP documents preparing, revising, and management of DS downstream department ;

组织并参与准备下游GMP文件起草,修订,管理等;

Ÿ Lead and participate in validation jobs of DS downstream department;

组织并参与准备下游生产的验证工作;

Ÿ Make production Plan according to the supply chainplan, include documents preparation, material preparation, buffer preparation, process operation, people management, 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,团队管理等相关活动;

Ÿ To be responsible for the training, instruction and management of DS downstream, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production;

Ÿ 负责下游的培训、指挥与管理,协调各个生产相关部门的沟通与合作,保证生产的顺利完成;

Ÿ Any other assignment as is determined by supervisor.

完成上级安排的其他工作。

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