职位描述
工作职责:
参与原液下游蛋白质纯化生产操作，包括但不限于缓冲液制备，AKTA纯化系统操作，低pH病毒灭活操作，除病毒过滤操作，超滤洗滤操作和最终原液分装。。执行生产、确认和验证工作，包括产品生产操作、车间清洁和产品切换清洁、设备操作、溶液配制、生产批记录审核和特殊样品协调。对问题解决、技术转移和投产准备提供支持。协助主管执行偏差调查、工艺数据分析和工艺过程改进工作。对工艺实验设计提供生产支持，如混合系统、产品转移和其他相关生物过程控制系统等。能够制备并介绍技术分享资料。了解cGMP需求和安全操作要求，并且针对内部和外部审计提供审计支持。
Participate in the execution of drug substance downstream protein purification processes, include but are not limited the following activity: the buffer preparation, AKTA process system operation, low pH viral inactivation operation, viral removal operation, UFDF operation and final filling operation. Execute manufacturing and qualification/validation activity, including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review and special sample coordination. Provide support in troubleshooting activities, technology transfer and start-up activities. Support supervisor to execute investigations, analyze process data and identify and implement process improvements. Provide support of process of experimental design with regard to system mixing, mass transfer, and other pertinent aspects of bioprocess system control. Author and present comprehensive technical presentations and procedures. Thorough understanding of cGMP requirements and safety practices and provide audit support to several internal and external audits.
主要职责 Role Responsibilities
？ 在SOP的指导下，进行原液的下游蛋白质纯化生产操作。包括但不限于缓冲液制备，AKTA纯化系统操作，低pH病毒灭活操作，除病毒过滤操作，超滤洗率操作和最终原液分装。
Perform DS downstream protein purification manufacturing under standard operation procedure, include but are not limited the following activity: AKTA process system operation, low pH viral inactivation operation, viral removal operation, UFDF operation and final filling operation.
？ 按照SOP要求在新建生产车间进行原液下游蛋白质纯化生产前准备，工艺放大及临床批次生产。
Perform standard operating procedures of DS downstream protein purification startup/scale up/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
？ 本科及以上药学、化工、生物、生物化学及其他相关专业。
BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
？ 有相关工作经验。
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.
？ 熟悉蛋白质纯化工艺及溶液配制者优先
Familiarity with 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.
？ 熟悉工业规模层析系统及超滤洗滤系统为加分项
Familiarity with manufacturing-scale 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
