30年医药行业研发、生产、质量管理工作经验,其中27年生物药经验、25年质量管理经验,作为主要人员参与过中国、EMA、FDA新产品上市检查和GMP认证检查,同时具有东南亚、南美、中东独联体等国家地区的GMP审计经验。精通质量体系的要求,熟悉临床、商业化产品生产的GMP要求,生物药原液和无菌制剂的生产,熟悉抗体偶联药物(ADC)、质粒、mRNA、LNP产品的质量保证,有能力处理质量体系运行中出现的复杂问题。
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质量副总裁Catug Biotechnology Sep 2022 - Present中国 江苏省 苏州市楷拓生物,提供质粒 mRNA LNP产品研发、GMP生产服务负责QA QC验证部门的管理。
Frequently Asked Questions about 段成才
What company does 段成才 work for?
段成才 works for Catug Biotechnology
What is 段成才's role at the current company?
段成才's current role is 楷拓生物 - 质量VP.
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