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质控品研发工程师(J12369)

Sansure Biotech · 湖南省·长沙市

Imported listingfull-time11 days ago

About The Role

  • 1.负责分子诊断质控品/标准物质研发，包括原料筛选、配方及制备工艺开发、性能优化；
  • 2.开展均匀性、稳定性、互换性等验证实验，输出研发、验证技术文档；
  • 3.熟悉NMPA IVD法规，遵循ISO13485体系，撰写全套研发注册技术资料，配合体系核查，完成研发转产技术交底；
  • 4.对接生产、质量部门，负责现有质控品工艺迭代、问题排查。
  • 1.本科及以上学历，分子生物学、生物技术、医学检验、生物工程等相关专业；
  • 2.3年以上IVD分子质控品或核酸试剂研发经验，参与过注册检验、资料撰写、审评整改；
  • 3.熟悉PCR分子实验，掌握质控品开发与稳定性研究，熟悉IVD注册法规及指导原则；
  • 4.文档能力强，严谨务实，具备项目推进与跨部门协作能力；
  • 5.有传染病、HPV、HBV等分子质控品项目经验优先。

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