Job Functions 岗位职责 61 Perform cell culture experiments related to cell line development; 负责细胞株开发项目相关的细胞培养实验; 61 Perform related activities such as medium and buffer preparation,and data record; 负责相关培养基和缓冲液的配制并记录数据; 61 Effective communication of data/results through written documentation and oral presentation of projects; 能够通过口头或书面形式,高效的报告项目数据; Cell Line Development 细胞株开发 61 Perform cell line development projects according to timelines; 根据时间表完成细胞株构建开发项目; 61 Record and evaluate experimental data on time; 按时记录和评估实验数据; 61 Participate in project meetings as CLD SME. Present and discuss the data and project progress at those meetings; 作为CLD项目SME参与项目会议,并在这些会议上汇报数据和项目进展; 61 Evaluate and report experimental results and ensure that research data and protocols align with CMC section of CTD packages; 评估并汇报实验结果并确保实验数据和相关方案与CTD文档中CMC版块的要求保持一致; Develop and optimize techniques for cell line construction to enhance the cell line development platform, including but not limited to vector design and optimization, process optimization; 开发和优化细胞株构建相关技术手段,提升细胞株开发平台, 包括但不限于载体设计和优化,开发流程优化; General 常规要求 61 Take responsibility of the general operation and maintenance of the equipment in cell line development lab; 负责细胞株开发实验室设备的日常运行及维护; 61 Comply with Company Policies and Procedures and contribute positively to Company morale; 遵守公司政策和程序,积极提升公司士气; 61 Other reasonably duties as requested by Company Senior Management from time to time. 有时需完成公司管理层提出的其他合理任务。 Safety and environment 现场安全和环境合规 61 Take a leadership role in site safety through promotion of safe workplace and personal action; 以身作则推动建立安全的工作环境; 61 Adhere to the Company’s safety and environmental protection procedures. 遵守公司的安全环保程序。 Quality Assurance 质量要求 61 Adhere to the Company’s Quality Assurance; 遵守公司的质量要求 Qualifications 任职资格 61 Master’s degree or above in molecular or cell biology, chemistry, biochemistry, or a related field. 分子或细胞生物学,化学,生物化学或相关领域,硕士以上学历。 Essential Experience 必要经验 61 Minimum of 5 years work in cell line development; 不少于5年在细胞株构建方面的经验; 61 Have experience in modifying vectors, sub-cloning of cDNAs into vectors, and associated molecular biology techniques; 熟悉载体优化,载体克隆和相关的分子生物学技术; 61 Expert knowledge in cell line development for recombinant protein products and has experience with multiple cell line development projects. 在重组蛋白产品细胞株开发方面具有专业知识,并有多个细胞株开发的项目经验; 61 Sound knowledge of regulatory requirements on manufacturing cell lines; 清楚了解生产用细胞株相应的法规知识; 61 Expert user of Microsoft Office applications (MS Word, Excel, Outlook); 熟练运用办公软件(MS Word, Excel, Outlook)。 Preferred Experience 优先考虑 61 Have industry experience to develop the cell line of recombinant protein in CDMO company and or Bio-pharma; 有在CDMO或者生物制药公司的重组蛋白产品的细胞株开发经验; 61 Experience in building and optimizing cell line platforms; 有细胞株平台搭建及优化经验;