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人福医药研究院-制剂(高级)总监(J33465)

China Merchants Group · 湖北省·武汉市

Imported listingfull-time3 days ago

About The Role

  1. 领导并管理制剂研发团队，统筹开展创新药制剂研究项目；
  2. 主导处方前研究、制剂处方设计及工艺开发，独立完成中美双报所需的制剂申报资料撰写；
  3. 参与创新药研发全流程及生产交接，为制剂工艺优化、中试放大及产业化提供技术指导；
  4. 制定制剂研究整体方案并推动按计划高质量交付；
  5. 落实环境、健康与安全（EHS）管理体系要求，确保所辖区域符合国家及企业相关规范。
  6. 博士研究生学历，具备10年以上创新药制剂研发及团队管理经验；
  7. 具备创新药研发全流程经验者优先，具有跨国制药企业（MNC）研发工作背景者优先；
  8. 精通药物制剂理论，熟悉增溶、促渗等关键技术，在难溶性药物开发方面有扎实实践；
  9. 熟练掌握主流制剂设备操作与日常维护，具备独立开展处方筛选、工艺优化及质量研究能力；
  10. 深入理解中美等主要市场的药品注册法规及技术要求，具有成功主导制剂模块申报经验。

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