BioNTech SE

ASAT理化经理

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

岗位职责:

  • 根据GMP标准和相关行业指南,为实验室调查和客户投诉提供技术分析专业知识和指导;
  • 开展分析技术转移项目,并在整个引入流程、技术转移和常规生产期间为CMO/新工厂提供支持;
  • 在技术转移和常规生产过程中提供分析性技术支持并开展问题解决活动;
  • 为实验室的故障排除和持续改进提供支持,并支持检查和质量审核;
  • 支持正在进行的产品开发与注册申报(BLA/MAA),作为分析领域专家(SME)参与法规申报文件制定及答复卫生当局问询;
  • 支持新成员融入BNT生产以及建立良好的沟通,并支持其日常运营;
  • 参与ASAT所属的标准操作规程(SOP)、工作指导书、技术文件包和其他支持性文件的创建、修订和批准;
  • 支持对所需新技术的评估和实施保持最先进的分析方法,与内外部需求保持一致;
  • 带领团队建立理化质量控制分析方法;
  • 参照各国药典建立理化方法平台;
  • 负责指导方法开发部门制定的非药典方法的方法转移,并组织人员对方法进行验证;
  • 完成领导交办的其他任务。

任职要求:

  • 本科及以上学历(985、211院校优先),生物化学、生物分析、分析化学等相关专业;
  • 在GMP生物制药企业有7年以上的相关工作经验;
  • 在制药行业具有丰富的分析和质量控制经验;具有HPLC和CE方法验证经验;
  • 熟悉生物制剂质量控制相关的全球药品法规(ICH、NMPA、FDA、EMA、USP、ChP、EP)并具有一定的GMP要求理解;
  • 熟悉生物药质量控制相关仪器、方法开发和方法验证;
  • 具有较强的独立思考和分析能力,能够根据实际情况提出解决方案;
  • 具有良好的人员管理能力、项目管理能力、良好的沟通技巧;
  • 具有良好的团队精神,认真负责工作并考虑问题;
  • 良好的英语听说读写能力。
  • 工作地点: 南通
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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