CMC Director 上海

月薪： 100万以上/年

该公司所有职位
  • 无工作经验
  • 硕士
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 出国机会
  • 绩效奖金
  • 年终奖金
  • 定期体检

职位描述

职位描述： Title: Director- CMC ManagementCompany/Location: Antengene Corporation/Shanghai Job Type: Onsite, Full-time employee Reporting to: CEOEssential Duties and Responsibilities: Lead the assigned products,focusing on DP,DS,Formulations during clinical stageLead the IND/NDA submission and filing Lead the the GMP Clean Room Installation of Qualification for the manufacturing facilityLead effective communication with internal and external responsible parties.Monitor and control the CMC process; within budget, and timeline.Required Skills and Abilities: Familiar with Chinese CMC regulations and guidelines applicable to oncology drugs including NDA and IND filing requirements.Strong working knowledge and cases of IND/CTA/NDA/GMP.Education/Experience Required: PHD preferred.Overseas educational background preferedContact: Please send your CV and cover letter to Peter.Qian@antengene.com 职能类别： 生物工程/生物制药

联系方式

华闻大厦

公司信息

Antengene Corporation is a clinical-stage drug development company focusing on introducing mid- to late-stage drug candidates from abroad to China, bringing to China Food and Drug Administration (CFDA) approval and launching products for Chinese market Antengene's approach is to leverage global medical innovation from the U.S. and Europe coupled with Antengene's expertise in clinical development and commercialization in Chinese market to alleviate cost pressures of innovators, accelerate product entry into China, expand/defend the business interest of its partners in Chinese market and ultimately meet huge medical needs of Chinese patients.

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