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【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

  • 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。

所在城市:
所任职位:
AC

企业信息

名称:
广东生物研发企业
行业:
制药.生物
性质:
私营/民营企业
规模:
100-499人

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