Full Time

DS Cell Culture Manager

Posted 1 month ago
Application ends: November 15, 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 DS upstream department. 上游
  • 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;
  • To be responsible for the training, instruction and management of DS upstream, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production.
  • 上游 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;
  • Effective management of product quality and cost control to ensure compliance with expected objectives and requirements 有效的管理产品质量与成本控制,达到公司预期的目标要求;
  • Manage upstream department headcount and personnel scheduling according to production plan and applicable employment policies.
  • Any other assignment as is determined by supervisor. 完成上级安排的其他工作。

Qualification Required

Education/ Professional Qualification

学历/专业资格

  • 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

  • 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;
  • Familiar with upstream cell culture techniques and scale up of Mab, including cell thaw, cell expansion, harvest and clarification. 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
  • 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

  • At least 5 years manufacturing experiences of manufacturing products and at least 2 years manufacturing 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

  • Good English and computer skill. 英语水平良好,会熟练使用电脑。

Others

其他

  • 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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