Analytical R&D Head

职位描述:

带领分析团队及时有效的完成所有项目任务,具体如下:

  • 负责指导监督整个分析团队的日常工作包括分析方法开发、验证、稳定性等研究工作;
  • 给予分析团队最科学的管理和指导,建立一支符合效率及合规性的分析团队;
  • 指导和监督所有ARD负责项目的方法转移和各项协调;
  • 审阅所有的ARD相关的技术文件,包括分析方法、报告、技术转移文件、SOP等;
  • 提供产品注册所需的支持文件等;
  • 协调内部分析和QA的要求确保公司CGMP政策的执行;
  • 参加国内外客户的技术及讨论会议;
  • 给予团队成员相应的技术、安全、GMP等方面的培训;

任职要求:

  • 博士学位,药物分析,分析化学或相关专业;15年以上分析研发的相关工作经验,其中 至少10年以上直接管理过ARD或者QC团队,如经验丰富可适当降低学历;
  • 熟练掌握HPLC、GC、LC-MS等分析仪器原理及色谱分析等
  • 熟悉国内外的GMP法规政策
  • 熟悉制药行业尤其CDMO的运作方式
  • 具有良好的沟通及协调能力
  • 优秀的英文听说读写能力

工作地点:中国上海,奉贤区

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