滁州 [切换城市] 滁州招聘滁州高级管理招聘滁州总监/部门经理招聘

CMC Director

葛兰素史克(中国)疫苗事业部

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2013-01-09
  • 工作地点:上海-浦东新区
  • 招聘人数:1
  • 工作经验:五年以上
  • 学历要求:硕士
  • 职位类别:总监/部门经理  

职位描述

Job Purpose and Key Responsibilities:

With the establishment of the iTCM BU and its near term goal of in-licensing and developing clinical stage drug candidates for China market and potentially global markets, there are immediate needs of senior leaders with extensive drug R&D experience in the relevant areas of CMC and manufacturing to take responsibilities in the following:

-Lead all CMC activities for iTCM projects
-Establish iTCM CMC development best practices and plans
-Identify and review potential natural product in-licensing candidates
-Lead CMC due diligence efforts
-Interact with and leverage GSK internal CMC expertise and resources for development needs
-Define and meet clinical manufacture needs, outline commercial manufacture plans
-Define supply chain control and management plans
-Establish preferred vendors/collaborators for GAP and GMP compliance
-Work effectively with other technical functional lines and matrix project teams

Accountabilities:

-Ensure CMC development best practices in iTCM BU for all projects

-Ensure in-licensing candidates are of suitable profile and quality for development and registration in China, potentially for global markets

-Ensure proper conduct of CMC due diligence

-Ensure proper quality of CMC technical and regulatory submission documents
-Ensure effective work relationship with other GSK and RDC CMC functional lines/stakeholders

Complexity:

- CMC development in iTCM is the most challenging and critical for program success. The CMC leaders will need to resolve numerous development issues by integrating technical knowledge and project experience with business drive and skills.
- The candidate needs to be very effective communicators, interacting with key stakeholders, regulators and other technical lines and matrix teams

公司介绍

葛兰素史克集团旗下的疫苗业务部是专业从事人用疫苗研究、开发、生产和销售的企业,总部设在比利时的Rixensart市,在全球范围内约有4500名员工,其中1600名科学家致力于疫苗的研发工作。

葛兰素史克是世界最大的疫苗生产供应商之一,疫苗产品线很长,贯穿人类生命的每个阶段。全球25%的疫苗是由葛兰素史克供应的,已上市产品超过30种。葛兰素史克的疫苗有很强的产品研发线,目前有超过20种疫苗在研发阶段。2009年,葛兰素史克疫苗全球销售额达37亿英镑,同比增长30%。

葛兰素史克的疫苗研究和生产始于上个世纪50年代,半个世纪以来,葛兰素史克为世界公共健康作出了杰出贡献,开发出了众多世界首例疫苗,如基因工程乙肝疫苗、甲乙肝联合疫苗、灭活甲肝疫苗、莱姆病疫苗、无细胞白百破/乙肝/注射用脊灰联合疫苗等。葛兰素史克还是唯一为世界卫生组织确定的三大全球疾病――疟疾、艾滋病和结核病同时研制药物和疫苗的公司。

1995年,葛兰素史克于上海浦东张江高科技园区内建立了疫苗生产基地----上海葛兰素史克生物制品有限公司。葛兰素史克是国内最大的外资疫苗供应商之一,为中国民众提供甲肝、乙肝、水痘、麻腮风、百白破、b型流感嗜血杆菌结合疫苗等。目前,葛兰素史克在中国已签署了两个新的合资企业,积极实现疫苗产品的本土化生产,为中国民众带来更多利益。

联系方式

  • 公司地址:浦东新区张江高科园区A5-4地块
  • 邮政编码:201206