BioNTech SE

QC微生物主管

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

岗位职责:

  • 主导环境监测相关工作,包括环境监测策略、风险评估及管理规程或操作规程的制定,组织洁净区、公用系统(水系统、空调系统、压缩空气等)的日常监控;
  • 主导环境数据的收集、统计分析及回顾,持续提升洁净区环境监测水平;
  • 组织微生物相关方法的建立以及验证工作,组织和负责微生物小组的项目检测工作,包括原液和制剂的放行,中间品的控制,原辅料和包材的入厂检测;
  • 主导菌种鉴定库以及环境菌株库的建立;
  • 组织和参与微生物污染事件的调查与分析;
  • 负责审核部门相关文件、记录、检验数据等;
  • 领导安排的其它工作。

任职要求:

  • 本科及以上学历,生物学、医药等相关专业;
  • 至少5年及以上微生物分析或检测经验,3年及以上的环境监测经历,至少两年以上QC管理工作经验;有无菌制剂产品相关经历的,有消毒剂效力验证的,优先考虑;
  • 熟悉中国药典、GMP、USP等国内外微生物相关的,包括检测方法、环境管理等法规;
  • 有丰富的应对官方、客户等审计经验,并制定有效CAPA;有污染控制策略制定的经验,优先考虑;
  • 了解生物大分子产品生产规律;熟悉检测方法及其原理,了解微生物的生长特性,能指导相关部门进行微生物管控;
  • 有特种设备作业证(压力容器);
  • 熟悉无菌隔离器、灭菌柜等微生物检测相关设备操作;
  • 具备良好的沟通协调及团队协作能力,有高度责任心和强烈的服务意识。具有项目管理能力;
  • 良好的英语听说写能力。
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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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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