【Senior Scientist】 Protein Group Leader-CMC 蛋白团队资深科学家
面议
东莞市博士及以上5年及以上
刷新时间:2019-02-14
职位描述
Key Responsibilities
This position will function as the technical lead overseeing upstream/downstream process development of therapeutic biologics and product manufacturing. The responsibilities include establishing CMC strategy, scale up, validation batches and CMC regulatory filing. You will:
Technical leadership for process development, analytical development, formulation development scale up, validation and manufacturing of biologic drug.
Support Quality and Regulatory Affairs.
Author relevant CMC section in regulatory filings and address agency questions.
Assist in recruiting, training and retaining a high performance team to ensure best quality services and leadership in CMC management functions
Requirements
Advanced degree (PhD or MS) in BioChemistry, BioChemical Engineering, Life Science or related major with 8+ years of applicable work experience.
Strategic view and leadership abilities as well as hands on problem solving skills.
Experience in managing projects is required.
Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry.
Experience with staff management and/or CMC team management.
Ability to effectively work across all levels, functions, sites and companies.
Excellent verbal and written communication skills in both English and Chinese.
Familiar with ICH, CFDA drug development regulations, CFDA or overseas experience in biological drug registration is preferred
其他要求
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1人
- 生物化学
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。