QC总监/经理 30-60万
苏州某生物大分子CDMO公司
所属部门:生产 汇报对象:总经理
不限 语言能力不限 0 岁-0 岁 3 年工作经验 性别不限
投递简历
QC总监/经理30-60万
苏州某生物大分子CDMO公司
所属部门:生产 汇报对象:总经理
不限 语言能力不限 0 岁-0 岁 3 年工作经验 性别不限
投递简历
职位描述
Lead the Quality Control Department for the Mammalian Business Unit with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics.<br/><br/> 1.Management of a diverse range of analytical, bioanalytical, and biological testing and support teams comprising of ~40 colleagues and future organizational growth to over 100 colleagues over the next few years to support a growing and expanding site.<br/><br/>2.Responsible for the development and implementation of a Quality Control strategy to meet business goals.            <br/><br/>3.  Responsible to ensure the QC operations comply to cGMP and safety regulations.  <br/><br/>4.  To evaluate and prioritize QC projects in the medium and long term, ensuring that the manpower, technical and financial resources are focused on the achievement of strategic objectives.  <br/><br/>5.  To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy.<br/><br/>6.  Plan resources for QC to support projects and testing in alignment with production activities.<br/><br/>7.  Lead QC department capacity and staffing planning and ensures QC has adequate resources and capabilities to meet the needs of the site and internal/external customers. <br/><br/>8.  To ensure the development and coaching of QC staff in order to improve their performance, abilities and competences.    <br/><br/>9.  Work closely with relevant functions including Process Development, Quality, Program Management and Business Development function to develop plan, budget and execute to exceed all biomanufacturing and overall company goals.  <br/><br/>10.   Maintenance of associated QC Laboratory systems, advancement of new QC technologies, Laboratory Information Management System (LIMS), laboratory investigation.<br/><br/><br/>
企业介绍
是一家聚焦于生物制药工艺开发与大规模生产的CDMO,成长速度快,两年8亿订单量。
工作地址
苏州
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