• 无工作经验
  • 招1人
  • 12-29 发布
  • 五险一金
  • 免费班车
  • 餐饮补贴
  • 专业培训
  • 年终奖金
  • 股票期权
  • 弹性工作
  • 定期体检

职位描述

Responsibilities:? Work collaboratively across multi-function teams to meet GMP project manufacture needs.? Guide method development/validation, responsible for method trouble-shooting. Monitor method performance and implement improvements to existing methods as needed.? Guide deviation/atypical data/OOS investigation.? Lead an analytical team of 5~8 staffs. Coach team members and ensure the achievement of team and individual performance goals.? Write and review study protocols, reports, SOPs, and filing documents.? Initiate and introduce new scientific knowledge and keep an updated regulatory knowledge.Requirements:? GMP Experience is must.? Ph.D., MS or BS in analytical chemistry or related field.? Ph.D. with 1+ years, M.S. with 4+ years, and B.S. with 6+ years of experience in HPLC/GC/GC-MS/IC/ICP-MS/NIR/Raman/etc method development/validation.? Strong knowledge of raw material, excipient and package material full release.? Familiar with ICH guideline, ChP/USP/EP/JP/YBB, and CFDA & FDA regulations.? Good communication skill, a good team worker, smoothly coordinating with other groups.? Can handle multiple projects at the same time and Comfortable in a fast-paced company environment. 职能类别: 药品生产/质量管理 关键字: QC 原辅料

联系方式

无锡滨湖区马山梅梁路108号

公司信息

使命 我们的使命是转变和加快制药发现、开发及在快速成长的生物制剂领域造福全球患者。 公司简介 药明生物技术(药明康德关联公司)提供全面、综合及可高度订制的生物制剂发现,开发及生产服务。我们是世界上唯一的开放式生物制剂技术平台,提供端到端解决方案,让任何人能从概念到商业化生产过程中发现、开发及生产生物制剂。我们提供的单源式服务为客户节省了宝贵的项目时间和费用。我们公司的历史和成就证明了我们为全球客户提供真正的一站式,开放式服务的价值主张和承诺。 更多信息,请登录公司官网:http://www.wuxibiologics.com.cn/

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