Manufacturing Director 天津

月薪：

该公司所有职位
  • 10年以上经验
  • 硕士
  • 招1人
  • 11-09 发布
  • 五险一金
  • 员工旅游
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 定期体检

职位描述

职位描述： 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. 职能类别： 生物工程/生物制药

联系方式

滨海新区中新生态城中天大道1620号研发大厦

公司信息

杰科（天津）生物医药有限公司是一家中美合资的生物制药公司，坐落于天津中新生态城。公司正在筹建包括研发、中试、质控及GMP生产等功能的大型生产基地，并陆续从国内外招聘优秀人才，组建一流的研发及生产团队。公司正在筹建的是中国规模最大之一的生物药物生产设施，其研发、生产及质量控制等设施均达到欧美设计建造标准。第一期工程将在三年内投产运行。杰科生物预计未来一期、二期共建设十条生产线，满足十多个生物药物的大规模GMP生产，达到1000-1500人的规模，产品包括单克隆抗体、抗体融合蛋白、细胞因子、重组蛋白或DNA疫苗等。

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