BioNTech SE

QC理化高级工程师

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

岗位职责:

  • 负责药典方法,及蛋白含量、蛋白纯度、等电点、电荷异质性、肽图等样品检测,及数据分析等;
  • 参与或主导理化分析方法的优化、转移、验证工作,包括撰写方案和报告,方案执行,及数据分析;
  • 负责管理和维护理化组及QC相关文件,包括撰写、复核、变更方法程序等;
  • 每项工作应遵守数据可靠性原则,符合ALCOA+ (可追溯、清晰、同步、原始、准确、完整、一致、持久、可用)规定。
  • 支持理化分析仪器的安装调试、验证等工作,负责仪器的日常维护保养;
  • 有责任和义务第一时间汇报异常(偏差、OOS、OOT、OOE、AE),并按相关规定参与调查处理;不断学习和提升,加强异常问题处理的锻炼;
  • 负责理化实验室试剂耗材、标准品等管理,现场5S维护;严格遵守公司EHS要求,确保操作安全;
  • 负责跟踪和掌握国内外关于理化方法相关的法规和指南要求,并进行差异分析,制定升级措施;
  • 其它公司和领导安排的工作,比如担任新员工的教练角色。

任职要求:

  • 至少3年以上抗体药物理化分析的相关工作经验;有Empower使用经验;
  • 熟悉至少3种以上方法的实验原理:肽图分析、纯度分析(SEC/反相检测)及氨基酸组成分析、蛋白浓度测定、等电点/毛细管电泳分析;
  • 了解现行版《中国药典》和GMP等相关法律法规,熟悉ICH Q2;
  • 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;能指导理化工程师工作;
  • 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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🔗 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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