Job responsibility 工作职责 Leadership 领导力 61 Lead cell line development team 领导细胞株开发团队; 61 Recruit, mentor, and manage staff; 负责招聘，指导和管理员工; 61 Accurately report status of cell line development activities for routine operation and projects; 准确报告细胞株构建相关的日常运营和项目状态； 61 Excellent project management skills with the ability to effectively coordinate cross-functional teams. 具有出色的项目管理能力，能够有效协调跨部门团队。 61 Represent the cell line development functions to customers, partners, investors, and government authorities; and 需作为细胞株开发团队的代表面对客户，合作伙伴，投资人和政府部门; 以及 61 Select and manage third party contractors to provide materials and services that supplement or complement internal capabilities. 选择管理第三方公司提供的物料和服务用以填补内部资源的短板。 Cell Line Development 细胞株开发 61 Lead the team to optimize and improve the cell line development platform, enhancing production efficiency and product quality. 领导团队优化和改进细胞株开发平台，提高生产效率和产品质量。 61 Introduce and implement the new technologies and methodologies to drive innovation in cell line development. 引入和实施新的技术和方法，推动细胞株开发领域的创新。 61 Manage the cell line development team to complete 10-15 cell line development projects in parallel approximately every six months, ensuring timely delivery. 61 管理细胞株开发团队以确保能在每6个月内并行完成10-15个细胞株构建项目开发, 确保项目按时交付； 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； 61 Standing member of the CMC Committee in support of the technical progress and regulatory filing of all products; 作为CMC团队的常务成员为项目开发提供技术和法规支持；
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 Prepare annual operating budget for cell line development activities and provide input into 3-year OPEX and CAPEX budget; 编制细胞株开发相关活动的年度预算并为3年的运营支出和资产支出预算提供意见； 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 Take a leadership role in Quality Assurance; 以身作则遵守公司的质量要求
Qualifications 任职资格 61 Bachelor’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。 Essential Experience 必要经验 61 Minimum of 8 years work in cell line development; 不少于8年在细胞株构建方面的经验; 61 Experience in managing staff of at least 5 technical specialists; 拥有管理至少5名技术人员的经验； 61 In-depth understanding and demonstrated experience in modifying vectors, sub-cloning of cDNAs into vectors, and associated molecular biology techniques 对载体优化，载体克隆和相关的分子生物学技术有深入的了解和实操经验； 61 Extensive experience in developing cell lines for recombinant protein products, monoclonal antibodies, bispecific antibodies, and complex proteins; 在重组蛋白产品、单抗、双抗及复杂蛋白细胞株开发方面具有丰富的经验; 61 Familiar with knowledge of regulatory requirements on manufacturing cell lines; 熟悉生产用细胞株相应的法规知识； 61 Previous responsibility for presenting to potential clients, investors, and government authorities; and 过去有负责过向潜在客户，投资者和政府职能部门进行宣讲的经验； 61 Expert user of Microsoft Office applications (MS Word, Excel, Outlook); 良好办公软件的运用（MS Word, Excel, Outlook）。
Preferred Experience 优先考虑 61 Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/NDA filing in China, USA and EU; 在CMC方面，拥有丰富的中国，美国和欧盟IND/NDA申报经验 61 Project management of CMC filing for US, EU, and China IND/NDA; 拥有美国，欧盟和中国IND/NDA申报的CMC项目管理经验； 61 Advanced computer system skills including Unicorn, Empower, and DoE and statistical analysis. 进阶计算机系统技能，包括：Unicorn, Empower, DoE和数据分析。
