Head of Bio-Manufacturing & Development 北京

月薪： 40-80万/年

该公司所有职位
  • 10年以上经验
  • 本科
  • 招若干人
  • 03-07 发布
  • 五险一金

职位描述

l To oversee the complex day-to-day work of biopharmaceutical drug substance manufacturing in a multi-product clinical facility to meet goals of quality, productivity and efficiency under cGMP condition.l To develop manufacturable processes for company new pipeline biologics drugs, scale up, and transfer to manufacturing.l Establish/maintain manufacture procedure, secure operation GMP compliancel Responsible to build, develop, and manage process development and manufacturing teams to achieve high performance levels and will be accountable for staff effectiveness. l Responsible for establishing, implementing, and maintaining cGMP systems and processes requirement to ensure high quality operation and compliance.l Responsible for developing and optimizing cell culture and protein purification process for company large molecule pipeline, and process characterization and validation.l Responsible for managing CMO activities.l Facilitate communication across functions internally and externally.l Responsible for developing and managing functional area capital and expense budgets, and develop models for resource, economic, and/or process analysis. l Manage and control production schedule, budget and headcount, ensure production performed on time and within budget.l Manage manufacturing supply chain, inventory control, and distribution for production need.l Responsible for driving and facilitating continuous process improvement and lean manufacturing. l Ensure effective and timely technical, GMP and safety training for manufacturing staff.Responsible for building new commercial facility including design, construction, equipment selection, IOQ, PQ, validation, and GMP system establishment.职位要求：l Master or above degree in Pharmacy, Biology, Chemistry, etcl At least 20 years pharmaceutical experiences in process development and manufacturing, and at least 5 years manufacturing managerial rolesl Fluent in English and Chinese，familiar with various automation software and electronic quality management systems.l Familiar with large scale biomanufacturing operation with disposable technology, and familiar with international GMP requirements.l Demonstrate a deep knowledge in protein/antibody process development（cell culture and protein purification）, scale up, and tech transferl Expert knowledge of biomanufacturing facility design, equipment selection, qualification, and validationl Ability to handle multiple tasks at the same time, prioritize, and complete tasks within tight timeline. l Anticipate complex technical issues and proactively develops practical solutions, proven ability to develop novel processesl Demonstrate ability to make sound recommendation and identify potential impacts to managementl Exceptional performance in leadership roles that contributed to the achievement of department/project team objectivesl Excellent communication skills that able to clearly communicate and accurately present scientific/technical information formally and informallySets a highly ambitious, clearly prioritized vision for the team; provide clear direction and define priorities for the team; listen to the different voices and win the commitment of team members.oNormal style="margin-left:21.0000pt;text-indent:-21.0000pt;text-align:left;mso-list:l0 level1 lfo1;" >l Ensure effective and timely technical, GMP and safety training for manufacturing staff.Responsible for building new commercial facility including design, construction, equipment selection, IOQ, PQ, validation, and GMP system establishment. 职能类别： 生物工程/生物制药 关键字： 生产经理 生产总监 制造总监

联系方式

Beijing

公司信息

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周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南

企业入驻日期： 2018-03-07

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