Full Time

DS Cell Culture Supervisor DS细胞培养主管

Posted 1 month ago
Application ends: November 17, 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

  • 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
  • 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
  • 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
  • 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。
  • 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
  • Any other assignment as is determined by supervisor.

Qualification Required

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。

  • Familiar with the regulatory requirement of CFDA cGMP、EU cGMP、PIC/S cGMP and FDA cGMP.
  • CFDA cGMP、EU cGMP、PIC/S cGMP及FDA cGMP的要求。
  • Familiar with upstream cell culture techniques and scale up of Mab, including cell thaw, cell expansion, harvest and clarification, can skilled operate at least one kind of bio-reactor. 熟悉上游细胞培养技术和工艺放大,包括细胞复苏,扩增培养,收获及物料澄清,至少能熟悉操作一种反应器。

Strongly address, investigate and solve ability.

具有较强的处理、分析和解决问题的能力。

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

Good English and computer skill

英语水平良好,会熟练使用电脑

  • Proactive and dedicated with a strong sense of responsibility and integrity;
  • Competent in organization and coordination, team leadership, analytical skills and problem solving;

Good communication skills.

具有良好的沟通表达能力;

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