Director-Manufacturing

50-80万元/年

天津市博士及以上10年及以上

刷新时间：2019-11-29

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

招聘人数：1人
汇报对象：CEO
职能类别：生产/质量

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。