制药生产经理岗位职责

生物制药生产工艺改善高级经理 药明生物 无锡药明康德生物技术股份有限公司,无锡药明康德生物,药明生物,药明 职责描述:

• Provide assistance to technical supervisor in supervising and coordinating manufacturing service and maintenance activity

协助技术主管进行生产服务和设备维护活动的管理

• Provide expertise on production vessel system (e.g. bioreactors, medium, buffer, product hold) and process of clean-in-place, sterilization-in-place or integrity test

支持生物制药工厂大型不锈钢罐体系统的使用和维护,以及为在线清洗灭菌, 完整性测试等工艺流程提供专家支持

• Provide fluid process engineering support for skids design, equipment selection, and for troubleshooting a range of manufacturing challenge

支持流体工艺系统设计,设备选型等;为系列生产工艺挑战提供解决方案

• Lead equipment related quality deviation investigation and communication; support regulatory and internal inspections

负责工艺设备方面的偏差调查,报告撰写,与客户和质量部门沟通;支持外部及内部审计活动

• Provide process engineering support for the commissioning, start-up and operation of biologics plant and/or new process installed in the facility meeting GMP requirement

参与新厂调试,启动和运营;支持新工艺/设备的调试运行, 达到GMP要求

• Develop and run computer process/unit modeling/ simulations in support of plant operations, process fit study,

任职要求:

• Master’s degree in Chemical /biochemical Engineering or related discipline with a minimum of 5 years of relevant experience in engineering or operations. Recent experience in a biologics production facility is required

• 化学工程或同等专业硕士,5-8年工作经验;须有近期在生物品制造厂工作经验

• Prior experience in operation or design around heat transfer, fluid processing, air/liquid transfer and fluid dynamics study, with good familiarity with CIP and SIP

• 有操作或者设计热传递,流体工艺,气体/液体传输,流体混合相关的系统或者公艺经验; 熟悉在线清洗和在线灭菌

• Understand the principles of fluid flow, heat transfer, mass transfer; understand biological process, and ASME BPE standard for bioprocess equipment

• 理解流体特性,传质,传热等化工原理;了解细胞培养和产品纯化流程及ASME BPE设备规范

• Proficiency in using at least one modeling software such as home-built Excel, Aspen, DesignPro or equivalent

• 能熟练使用一种模拟软件,自建或者商用模拟

• Exceptional problem solving and analytical skills.

• 优秀的分析能力和解决问题的能力