BioNTech SE

细胞培养高级工程师

BioNTech SE  •  Nantong, CN (Onsite)  •  4 months ago
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Job Description

岗位职责:

  • 参加GMP培训并遵循GMP规则在车间内完成生产任务;
  • 参与上游小组执行细胞的复苏解冻,细胞在摇瓶和反应器中的扩增培养以及细胞在反应器阶段的生产和收获;
  • 参与生产上游部门GMP相关文件的撰写、升版、执行;
  • 收集和及时上报技术转移、工艺放大及日常生产中遇到的问题,并及时处理生产现场发生的常见问题,改进并优化生产流程及工作方法,定期进行总结和汇报;
  • 负责小组内生产人员的技术、设备、规范、工艺等相关文件的培训与考核;
  • 负责变更的发起和参与风险评估以及方案制定等工作;
  • 负责生产中出现的偏差、偏离、异常事件的调查和改进工作(偏差、变更、CAPA等);
  • 参与NMPA、FDA等审计部门或合作单位审计,并根据审计整改项执行整改及反馈;
  • 与研发部门、供应链部门、工程部门、QA部门、QC部门等相互合作,推进生产的顺利进行。

任职要求:

  • 本科及以上学历,生物类、制药类相关专业;
  • 本科及以上学历;生物化学、生物制药和发酵工程等专业优先;
  • 有8年及以上相关生物制药行业GMP工作经验者;
  • 熟悉上游生产设备的操作原理、维护、管理;
  • 熟悉生物药GMP厂房的运行和管理;
  • 具有良好的沟通表达能力;
  • 熟悉生物制药领域GMP的相关法规要求;
  • 熟悉偏差发起、调查、关闭和CAPA执行的整个质量管控过程;
  • 具备一定的英文阅读和书写能力,能够审阅GMP相关文件;
  • 具有吃苦耐劳的品质和良好的身体素质,与积极向上持续学习的能力;
  • 熟练使用Office、Visio等办公软件。
BioNTech SE

About BioNTech SE

Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.

BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.

BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.

Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html

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🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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