• 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述: Assistant/Associate Director, Stability, Analytical SciencesWuXi Biologics in ShanghaiRESPONSIBILITIES:?Lead the Stability Group in Analytical Sciences?Strategic oversight and guide all the stability studies performed in Analytical Sciences?Provide dynamic forecast of upcoming stability projects to the senior management team for management of resources and workload?Collaborate with other functions to meet projects timeline and deliverables?Serve as subject matter expert for all stability matters, Participate and lead any stability investigations?Lead the stability team and improve stability program management?Develop talent, inspire innovation and operational excellence and foster a continuous learning environment.?Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.QUALIFICATIONS:?The candidate must demonstrate solid working knowledge of biologics development processes?Project experience of IND filing (Domestic or Global projects)?Understand the global stability regulatory requirements with knowledge of FDA/EMA/CFDA/ICH regulations and guidance on stability?Be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).?MS or PhD degree in Analytical Chemistry, Biochemistry or other related life sciences degree and 8+ years of relevant biotechnology industry experiences.Contact:Dr. Gang Huang,Vice President, Analytical Sciences & Quality Control & Regulatory Affairsgang_huang@wuxiapptec.com 职能类别: 生物工程/生物制药

联系方式

上海市外高桥保税区富特中路288号

公司信息

药明生物(WuXi Biologics)是香港上市公司(代码:2269),我们是全球领先的开放式、一体化生物制药能力和技术平台,旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司,并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务,帮助任何人、任何公司发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。目前,公司规模达到2300多人,有200多位拥有海外高等学位和工作经验的海归科学家,拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验,打造了世界一流的生物药研究、开发及生产团队。 更多信息,请登录公司官网:http://www.wuxibiologics.com.cn/

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