BioNTech SE

QC生化经理

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

岗位职责:

  • 管理和指导质量控制理化部门的工作,确保公司的GMP质量控制系统符合国内外法规机构的要求;
  • 建立抗体药品质量控制平台及相应的文件体系;组织实验室文件的起草和审核,包括SOP、原始记录模板、仪器软硬件的4Q,指导检测人员遵章操作;
  • 参与质量部供应商管理体系的建立;
  • 带领团队建立生化质量控制分析方法;参照各国药典建立生化方法平台;
  • 接收方法开发部门开发的非药典方法,并组织人员进行方法验证;
  • 建立和执行QC的数据完整性管理,按照cGMP的要求,对组内成员的原始记录进行抽查,确保数据可追溯性及真实性;
  • 负责部门发展规划和预算,财务控制,人员架构及运营成本控制;
  • 负责执行质量控制相关的培训工作,提高QC人员的专业技能;负责本部门员工的考核;指导和支持各相关部门的相应工作;
  • 负责团队的搭建(人员招聘、文化建设、人员培养等),绩效评定;
  • 完成领导交办的其他任务。

任职要求:

  • 本科及以上学历,生物化学,生物分析,分析化学等相关专业;
  • 7年以上GMP生物制药企业的相关工作经验,3年以上管理工作经验;
  • 具有丰富的制药行业分析和质量控制经验,具有细胞生物活性方法开发或检测经验;
  • 具备较好的英语听说读写的能力;
  • 熟悉国内外生物药品质量控制的相应政策和法律法规(ICH、NMPA、FDA、EMA、USP、ChP、EP),GMP要求;
  • 熟悉生物药品质量控制的相应仪器应用,方法开发和验证;
  • 良好的人员管理能力、项目管理能力,良好的沟通表达能力;
  • 较强的独立思考和分析能力,能根据实际情况提出方案;
  • 工作认真负责、考虑问题细致、有良好的团队合作精神。
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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