BioNTech SE

QC生化工程师

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

岗位职责:

  • 负责生化分析仪器新设备安装调试、验证工作,包括起草设备标准操作规程,能解决仪器常见问题;
  • 负责执行生化分析方法优化、转移、验证及日常分析的工作;分析方法包含但不局限于结合活性、HCP、Protein A、DNA等;
  • 负责产品的稳定性研究;
  • 根据SOP完成测试,保证实验过程和结果的及时性和准确性;
  • 负责生化实验室试剂耗材的管理和维持现场6S;
  • 严格遵守公司EHS安全法规,掌握安全工作技能和应急救援知识;
  • 保持QC实验室的高GMP合规性和DI。
  • 负责配合生化主管完成实验室发生的偏差、OOS/OOE/OOT等的调查,严格按照CAPA要求实施;
  • 协助部门按时完成项目进度;
  • 跟踪和熟悉国内外关于生物分析方法相关的法规和指南要求;
  • 担任培训新员工的教练角色。

任职要求:

  • 本科以上学历,生物化学,生物分析,生物技术等专业背景;
  • 至少2年以上抗体生化分析的相关工作经验;
  • 理解酶标仪和Q-PCR仪的工作原理,熟练使用结合活性,HCP,Protein A和DNA等方法对大分子进行生化分析;
  • 熟悉现行版《中国药典》、《欧洲药典》、《美国药典》、GMP等相关法律法规;
  • 能在cGMP环境中独立执行分析工作,并最大限度地减少实验室误差;
  • 具备良好的职业素养和团队协助能力;
  • 熟悉企业现代化管理,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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🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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