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生产下游总监

面议

浙江省

刷新时间:2023-10-11

职位描述

• Lead the effort on establishment of a state-of-the-art biologics downstream purification process development platform at Pharmaron Biologics.

• Lead and manage daily operations of the downstream purification process development function with high productivity, efficiency, and quality.

• Design and optimize downstream processes that are suitable and scalable for clinical and/or commercial manufacturing.

• Provide oversight of process scale-up and technology transfer between the process development team and manufacturing team.

• Author, review and approve necessary documents including but not limited to protocols and reports for purification process development, technical transfer, process characterization and validation, batch records etc.

• Effectively prepare and present scientific findings and proposals to internal and external parties as needed.

• Keep abreast of the advancement of new technologies in the relevant biologics CMC areas and apply to the ******’s projects as appropriate.

• Take active roles in department and corporate planning, budgeting, recruiting and employee training, coaching and mentoring.

• Work collaboratively and effectively with cross functional teams.• PhD in biochemistry, biochemical engineering, biotechnology, or other life science disciplines, with at least 6-10 years of industry experience focused on biologics downstream process development.

• Expert knowledge and experience in biologics downstream process development. Familiar with laboratory procedures and operations including lab scale chromatography systems, depth filtration, centrifugation, UF/DF, viral inactivation and removal.

• Familiar with downstream process scale up and GMP manufacturing processes. Proven track records in successful development of downstream process and scale up for GMP manufacturing process.

• Extensive experience with authoring, reviewing, and approving various technical documents relevant to downstream process development, and clear understanding of regulatory filing requirements in different territory.

• Ability to work effectively in a highly collaborative and dynamic environment with cross functional teams.

• Ability to mentor and motivate team members to achieve high performance.

其他要求

  • 1人
  • 生产总监/副总

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

Li

所在城市:
所任职位:
BP

企业信息

名称:
某知名上市企业
行业:
制药.生物
性质:
外商独营/外企办事处
规模:
10000人以上

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