广州欣凯化工科技有限公司
制剂经理
2 months ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
31 August 2026
What they need
该职位来源于猎聘 岗位职责: 1.负责口服固体制剂项目:包括研究方案的设计和组织技术实施、解决关键技术问题、完成小试和中试放大生产;申报资料撰写等; 2.负责口服固体制剂项目管理:项目进度管控、资源调配、保证研究申报资料符合申报注册法规要求; 3.负责团队建设和管理。 岗位要求: 1.博士1年或研究生8年以上工作经验;
- 具备较好的制剂理论知识,熟悉口服固体制剂研究开发全过程。至少有两个仿制药研发和申报经验,有CRO工作经历者优先; 3.具备较强的科研素质和能力,能够分析和解决技术问题; 4.熟悉口服固体制剂研发和生产所用设备的原理和性能,熟悉设备的工艺操作; 5.熟悉国际(包括ICH,FDA和EMA)研发技术要求及国内药品技术审评要求和药品注册的相关法规; 6.具备较好的中英文文献检索及解读能力。 7.具备制剂项目管理经验,能够协调团队高效合理的开展工作; 8.善于沟通,勇于承担、敬业进取、态度积极、正直向上;
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