职位描述

职位描述： 工作内容： – 针对在CRO生产的CTA批次提供支持。 Provide local execution support during CTA lot execution at CROs. – 按照SOP要求在新建生产车间进行制剂原料生产前准备，工艺放大及临床批次生产。 Perform standard operating procedures of DS startup/scaleup/clinical lots production in new facility. – 在主管的指导下编写相关文件，如生产批记录，SOP和验证报告等。 Author documentation such as batch records, procedures, and validation reports as directed by supervisor. – 对关键操作提供实时一次正确率支持。 Provide real-time RFT support of critical operations. – 与主管一起沟通解决生产操作中的不一致行为。 Work with supervisor to communicate and resolve operational variances. – 负责工艺监控，包括工艺参数和工艺数据/趋势分析的实时回顾。 Process monitoring including real time review of process parameters and process data/trend analysis. – 负责部门间和班组间的信息沟通。 Communicate process performance across shifts and departments. – 协助主管进行工艺改进，设备能力评估和新技术的使用。 Support supervisor to Implement process enhancements, measure and respond to equipment capability and implement new technologies. – 保证操作符合质量安全规章。 Execute operation following QEHS regulations. – 参与调查和变更控制，确保变更具有附加价值并且变更后工艺和设备稳定。 Participate investigations, and change controls to ensure changes are value added and processes and equipment are robust. – 参与创新文化和持续改进。 主动领导变更能够提高一次正确率，生产效率和成本减少。 Participate a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs. – 提供审计支持。 Provide Audit support 。 – 执行主管分配的其他工作。 Execute other items assigned by supervisor. – 根据生产需要进行倒班生产。 Attend shift work according to manufacturing requirement. 任职资格： 教育程度/经验 Education/Experiences – 高中以上学历，药剂/药学相关专业。 BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field. – 有相关工作经验者优先。 Experience working in related environment is a plus. 特别知识/技能 Specific Knowledge & Skills – 良好的英语口语和写作能力 Good English oral and written communication skills are required. – 熟悉哺乳动物细胞培养或蛋白质纯化工艺及溶液配制者优先 Familiarity with mammalian cell culture and/or protein purification process. Solution formulation is not essential, but is highly desirable. – 熟悉GMP生产为加分项。 Familiarity and experience with a GMP manufacturing environment is a plus. – 熟悉工业规模生物反应器，连续离心机，层析系统及超滤洗滤系统为加分项 Familiarity with manufacturing-scale bioreactors/fermentors, centrifuge, column chromatography and/or tangential flow filtration (UF/DF) a plus – 有6西格玛及5s管理经验者优先 Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus 职能类别： 其他

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