纯化总监或者CB03-纯化生产副总监
面议
上海市
刷新时间:2023-10-23
职位描述
Sr. Director / Director of Purification Process Development Dept.
Main responsibilities include:
·Lead a team of scientists /engineers and associates to develop, scale-up and transfer purification processes from small scale to production scale for therapeutic proteins, antibodies and ADC drugs.
·Develop and optimize the purification processes to achieve higher purity, yield and robustness.
·Design, execute and supervise purification process development programs.
·Perform technology transfer and scale-up activities seamlessly from lab-scale to large-scale production.
·Assist the purification team to perform virus clearance study.
·Support pilot and large-scale production technically and solve technical issues.
·Have good communication skills with ******s in written and oral formats.
·Write and review technical reports and regulatory submission files.
·Manage multiple projects as project leaders in parallel with different priorities.
·Assist BD and marketing teams to acquire new projects.
·Day-to-day team operation management.
Requirement:
·Ph.D. degree in biochemical engineering, cell biology, biochemistry, molecular biology, or other related fields is required.
· A minimum of 10 years of working experience in biopharmaceutical development environment with good track record in purification process development is required. Experiences in international biotechnology companies are preferred.
·Extensive experiences on antibody, recombinant proteins / enzymes and ADC development at small and pilot scale, including but not limited to major aspects of unit operations in chromatography, TFF or ADC conjugation at bench-top and pilot scale, etc.
·Highly experienced in assessing, communicating and streamlining technology and process transfer between development and manufacturing. Process development or manufacture experience with commercial biopharmaceutical products is a big plus.
·Excellent troubleshooting skill is needed.
·Experience with ADC conjugation and purification is a great plus.
·Has leadership vision, with good management,team building and results driven skills.
·Fluent communication in both English and Chinese.
·Good experience in regulatory submission for NMPA, FDA, and EMA is preferred.
其他要求
-
1人
- CMC
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。