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Director-Manufacturing

50-80万元/年

天津市博士及以上10年及以上

刷新时间:12小时前

职位描述

TITLE: Director, Manufacturing

LOCATION: Tianjin, China

Report to: CEO

Responsibilities:

Work with the technology transfer department to finished the process & engineering amplification and process optimization.

To be responsible for pilot scale production and clinical production.

To be responsible for implementation of manufacturing with coordination of all resources, QC for in process testing, facility maintenance, engineering, and administrative support.

Solve comprehensive manufacturing problems including prioritizing manufacturing activities, schedules, and resources in aligning with company’s priority.

To be responsible for the team building, budgeting, project timeline management, personnel training and performance evaluation of the manufacturing team.

Collaborate with quality departments on facility qualification including utility calibration and validation, process validation, personnel GMP training, environment monitoring, QC testing, and final product releasing.

Assist regulatory affair activities for DMF, IND, and NDA/BLA submission.

Other assignments from the direct manager.

Minimum Requirements:

Graduate degree in biochemical engineering, biological sciences or related field. Minimum 10 years biopharmaceutical experiences with ~5 years managerial responsibilities at a level of senior manager of a department. Ph.D. is a plus.

Extensive experiences with microbial fermentation, mammalian cell culture, protein purification, formulation, viral vector production, and PAT in in-process testing.

Extensive large scale manufacturing experiences with GMP operation background.

Extensive management experiences. Strong leadership, organization ability, wide range of GMP knowledge on FDA or EMA or CFDA regulation.

The candidate must be excellent with bilingual (English and Chinese) communication, professional writing and interpersonal skills.

其他要求

  • 1人
  • CEO
  • 生产质量研发

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:
杭州市
所任职位:
猎头顾问C

企业信息

名称:
诗迈医药猎头
行业:
制药.生物
性质:
中外合营(合资/合作)
规模:
50-99人

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