BioNTech SE

QC物料工程师

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

岗位职责:

  • 负责QC实验室原辅料与包装材料的检验及相关工作;
  • 负责原辅料及药包材的质量标准的建立、维护与更新;
  • 负责原辅料及药包材的检验规程的建立、维护与更新;负责检测方法的确认或验证;
  • 负责原辅料检验用分析仪器的引入与确认;
  • 负责执行原辅料与药包材的取样与检验;
  • 负责原辅料及药包材第三方实验室的确认与管理,以及第三方实验室委托检验的管理;
  • 负责原辅料检验过程中偏差及OOS的调查、以及变更的处理。
  • 与QC内部理化、生化、微生物、运营等组密切协作,确保样品检测及时、准确;
  • 完成上级领导交付的其他工作。

任职要求:

  • 至少5年及以上原辅包的检测经验,有生物制品行业相关经历的,优先考虑;
  • 掌握多种物料检测方法能力,如化学鉴别、含量和杂质等;掌握相应检测设备的工作原理,如IR、UV、HPLC、GC等;
  • 熟悉中国药典、GMP指南,及ICH等关于原辅料管理的法规和指南等;了解EP、USP等国外药典关于物料管理;
  • 能在GMP环境中独立执行分析工作,并最大限度地减少实验室误差;
  • 英语看说写熟练;
  • 具备良好的职业素养和团队协助能力;
  • 熟练使用 MS-Word, MS-Excel, MS-Outlook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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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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