职位描述
工作职责:
？ 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原液生产前准备，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
- 本科以上学历，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
