BioNTech SE

ASAT原辅料经理

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

岗位职责:

  • 作为技术转移活动的一部分,负责建立主要原材料质量标准、变更以及实施新原材料和消耗品的质量标准;
  • 为复杂调查的故障排除和实验室系统的优化提供SME支持;
  • 作为技术主题专家(SME),参与评估原材料和辅料的检测策略,并参与监管检查和客户稽查,以支持QC原材料活动;
  • 优先考虑并专注于优化实验室系统和新技术,包括使用IT系统(例如Labware)和新仪器来实现原材料检测的现代化;
  • 与QC分析开发、QC项目管理、生产、工艺科学和质量保证相关方进行跨职能合作,以实现公司目标;
  • 与研究中心专家合作,领导风险评估并实施与原材料检测和质量标准相关的风险缓解策略;
  • 准备并参与内部和外部审计,提供专业知识并确保所有综合方法符合全球监管标准;
  • 与质量保证、生产和法规事务团队紧密合作,支持产品开发并确保无缝操作;
  • 及时了解原材料测试技术的最新进展,并将相关创新融入现有流程;
  • 根据ChP/USP/EP/JP指导原则支持方法开发和验证;
  • 根据需要,撰写、审查并批准数据报告、超出质量标准(OOS)和趋势偏离(OOT)调查、偏差、CAPA和变更控制;
  • 完成领导交办的其他任务。

任职要求:

  • 学士学位,且在GMP环境中拥有8+年经验或 拥有GMP环境工作经验6+年以上的硕士学位或 博士,具有GMP环境4+年经验;
  • 5+年分析检测经验,最好有原材料检测经验;
  • 具有分析检测经验,最好是在生物制药行业进行的原材料检测;
  • 对原材料试验(风险评估)的基于风险的方法有深入的了解 良好的英语听说读写能力;
  • 熟悉原材料检测的全球药物法规(ICH、NMPA、FDA、EMA、USP、ChP、EP);
  • 卓越的沟通和领导能力,能够在跨职能团队中有效工作;
  • 具有Microsoft Office、Smartsheet和实验室LIMS及ERP系统(例如SAP)的经验。
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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