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
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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。