BioNTech SE

生化分析经理

BioNTech SE  •  Zhuhai, CN (Onsite)  •  6 hours ago
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Job Description

岗位职责:

  • 开发、优化和实施抗体类产品细胞活性分析方法。
  • 建立和优化生物功能分析方法,包括报告基因法、中和活性法、ADCC、CDC和受体结合分析等。
  • 负责细胞活性分析方法的确认、验证和方法转移工作。
  • 负责HCP、Protein A残留和残留DNA检测方法的开发、验证和持续优化。
  • 支持细胞株开发、工艺开发、制剂开发、稳定性研究及可比性研究。
  • 撰写并审核分析方法开发方案、验证方案、技术报告、SOP及相关技术文件。
  • 参与注册申报相关分析资料的准备及技术支持工作。
  • 参与OOS/OOT调查、偏差处理、变更控制及实验室调查活动。
  • 负责实验数据分析、趋势评估及技术问题解决。
  • 指导研究员或高级研究员完成实验工作,并提供技术培训。
  • 与研发、CMC、质量、注册及外部合作方保持良好沟通,推动项目顺利实施。
  • 能够使用英语参与技术讨论、项目会议和技术交流。

任职要求:

  • 生物学、生物化学、细胞生物学、药学、生物工程或相关专业硕士及以上学历。
  • 具有8年以上生物制药行业分析开发经验。
  • 具备抗体类生物药的细胞活性分析方法开发和优化经验。
  • 熟悉单克隆抗体、双特异性抗体及相关生物药产品的作用机制和生物活性分析策略。
  • 具备细胞活性分析方法开发、确认、验证及转移经验。
  • 熟悉细胞活性分析技术,包括报告基因法、细胞增殖法、细胞毒性法、中和活性法、ADCC、CDC及受体结合分析等。
  • 具有宿主细胞蛋白(HCP)、Protein A残留、残留DNA等杂质分析方法开发和验证经验;
  • 熟悉ELISA、MSD、qPCR/ddPCR、流式细胞术(Flow Cytometry)、细胞成像等分析平台;
  • 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;
  • 有较好的英文读写能力,能够阅读英文文献、法规和注册资料,并能够参与英文技术讨论和会议。
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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