Associate Director/Manager, Cell Therapy Process Development
面议
上海市
刷新时间:2021-04-22
职位描述
Duties and Responsibilities:
Lead and execute process development studies for manufacturing of CAR-T and TCR cell product, as well as non-viral and viral vector products.
Participate in and provide manufacturing process troubleshooting support.
Work with program stakeholders in developing and implementing analytical methods for the
manufacturing in-process testing.
Participate in team effort to establish early product definition, manufacturing science, and
method of delivery and use in the clinic.
Develop and maintain detailed and comprehensive project timelines and budgets.
Participate in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
Present updates to project teams on process development and manufacturing support activities.
Maintain a high level of knowledge in gene and cell therapy, particularly in the field of CAR-T
product development and manufacturing.
Collaborate with other departments with an eye toward future commercialization of our exciting biological products.
Serve as an internal resource for R&D regarding manufacturing science, analytical, formulation
and delivery issues.
Education and Experience
Ph.D. degree in Chemical Engineering, Molecular Biology, Analytical Chemistry, Immunology or
equivalent with 5+ years’ experience in biotech development with particular experience in gene and cell therapy product design. Experience with oncology, gene modified T cell products (CAR-T, TCR) a plus.
Experience and knowledge in cell and gene therapy product design.
Experience and knowledge in process development for GMP cell therapy and vector product
manufacturing.
Experience and knowledge in analytical development and implementation for GMP cell therapy and vector product manufacturing.
Experience in immunology.
Experience with technology transfer.
其他要求
-
1人
- 研发总监/研究院院长
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。