Job responsibility 工作职责 61 Management requirements 管理要求 1. Lead the downstream production team to complete the downstream production tasks as planned 带领下游生产团队按照计划完成下游生产任务。 2. Be responsible for the facilities and equipment used in downstream workshop production. 负责下游车间生产所使用的设施和设备。 3. Manage routine or unconventional projects, arrange production plans, and implement plans to achieve results that meet customer requirements. 管理常规或非常规的项目，安排生产计划，执行计划达到符合客户要求的结果。 4. Be responsible for the recruitment, guidance and management of the Department; And participate in the technology transfer of new projects and / or existing projects 负责部门的招聘和指导并管理工作；并参与新项目和/或现有项目的技术转让。 5. Be responsible for safety and environmental compliance at the production site 负责生产现场安全和环境合规 6. Ensure the safety production in the workplace and be responsible for the personal behavior on the site of the workshop in line with cGMP norms, and play a leading role in site safety; And comply with the company's EHS procedures. 保证工作场所安全生产和负责车间现场个人行为符合cGMP规范，在现场安全方面发挥领导作用；并遵守公司的EHS程序。 61 Production requirements 生产要求 7. Manage the supervisor and operator team to provide sterile DS for IND production batch until BLA application 管理主管和操作员团队，为IND生产批次提供无菌原液，直至BLA申请 8. Optimize production operations by guiding daily production activities. Ensure that production planning activities are carried out as planned 通过指导日常生产活动来优化生产操作。确保生产计划活动按计划进行 9. Monitor and report production efficiency, minimize product quality risks, and reduce variable standard costs 监控和报告生产效率，***限度地降低产品质量风险，降低可变标准成本 10. Prepare annual production budget and personnel budget. Ensure that the budget objectives are met, and provide sufficient facilities, equipment and personnel resources for the production and operation Department to meet the customer's project needs 编制年度生产预算和人员预算。确保满足预算目标，同时为生产运营部门提供充足的设施、设备和人员资源，以满足客户项目需求 11. Prepare BPR, personnel training plan, URS and other technical documents (such as standard operating procedures or validation agreements) to support technology transfer and production. Ensure that the document is consistent with the CMC part of IND/BLA 编写BPR、人员培训计划、URS和其他技术文件（如标准操作程序或验证协议）为技术转让和生产提供支持。保证文档与IND/BLA的CMC部分保持一致 12. Provide expert advice to CMC Committee and provide technical support for downstream production 向CMC委员会提供专家建议，提供下游生产的技术支持 13. Have rich downstream production experience. 具有丰富的下游生产经验。 14. Use a variety of problem-solving tools and techniques, use appropriate resources, personal knowledge and experience, and use any available resources to solve problems in specific situations 使用多种解决问题的工具和技术，利用适当的资源、个人知识和经验，在特定情况下利用任何可用资源解决问题 15. Support the transfer of technology and coordinate resources, including the secondment of R & D personnel for production. 支持转让技术工作，协调资源包括为生产借调研发人员。 61 General requirements 常规要求 16. Be responsible for the maintenance of downstream production workshop equipment and facilities to ensure the normal operation of downstream production workshop; 负责下游生产车间设备和设施的维护，保证下游生产车间正常运行; 17. According to the budget management department's annual expenditure and project capital expenditure; 根据预算管理部门年度支出和项目资本支出; 18. Prepare and submit capital expenditure applications for downstream facilities and equipment; 准备并提交下游设施设备的资本支出申请； 19. Maintain effective, collaborative and frequent interaction with customers and other departments to ensure the effective transfer of technical methods 与客户和其他部门保持有效、协作和频繁的互动，以确保技术方法的有效转移； 20. Abide by the company's policies and procedures, and actively improve the company's morale 遵守公司政策和程序，积极提高公司士气； 21. Actively complete the tasks assigned by the superior. 积极完成上级布置的工作任务。 22. Have good communication skills. In the early stage of business negotiation and quality audit, you can reduce or dispel customers' doubts through your own technical ability and background, and help the company win orders. 具有良好的沟通能力，在前期商务谈判和质量审计阶段，可以通过自己的技术能力和背景降低或打消客户的疑虑，帮助公司赢得订单。 Safety and environment 现场安全和环境合规 61 Promote a culture of safe work place through personal actions. 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 All pharmaceuticals production and packaging should follow approved process procedures and operation procedures, and the relevant records should be kept in order to obtain products of the requisite quality and be in accordance with the relevant manufacturing and registration requirements. 所有药品的生产和包装均应当按照批准的工艺规程和操作规程进行操作并有相关记录，以确保药品达到规定的质标准，并符合药品生产许可和注册批准的要求。 61 Operation procedures for division of production batches should be established. The batch division should be able to ensure the consistency of product quality and characteristics in the same batch. 应当建立划分产品生产批次的操作规程，生产批次的划分应当能够确保同一批次产品质和特性的均一性。 61 Operations on different kinds of products should not be carried out in the same operation room at the same time unless there is no risk of mix-up or cross-contamination. 不得在同一生产操作间同时进行不同品种和规格药品的生产操作，除非没有发生混淆或交叉污染的可能。 61 At every stage of production, products and materials should be protected from microbial and other contamination. 在生产的一阶段，应当保护产品和物料免受微生物和其他污染。 61 At all times during production, all materials, intermediate product or bulk product, major items of equipment and where appropriate rooms used should be labelled or otherwise identified with an indication of the name, strength and batch number of the product or material being produced, When necessary, this indication should also mention the stage of production. 生产期间使用的所有物料、中间产品或待包装产品的容器及主要设备、必要的操作室应当贴签标识或以其他方式标明生产中的产品或物料名称、规格和批号，如有必要，还应当标明生产工序。 61 Normally, line clearance should be carried out after every production completion, to ensure the equipment and work station are clear of any material, product and document related to this production. Before any processing begins, there should be confirmation on previous clearance. 每次生产结束后应当进行清场，确保设备和工作场所没有遗留与本次生产有关的物料、产品和文件。下次生产开始前，应当对前次清场情况进行确认。 61 Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occurs, it should be handled according to the deviation operation procedure. 应当尽可能避免出现任何偏离工艺规程或操作规程的偏差。一旦出现偏差，应当按照偏差处理操作规程执行。 61 Prepare, review and approve quality management system documents, including technology transfer documents and downstream system documents 编写、审查和批准质量管理体系文件，包括技术转让文件和下游体系文件； 61 Review and approve batch production records and comply with the company's quality management system, including timely resolution of quality related issues (such as deviation, CAPA and change control); 审查和批准批量生产记录，并遵守公司质量管理体系，包括及时解决质量相关问题（如偏差、CAPA和变更控制）； 61 Regularly inspect the workshop site, record, etc., optimize and improve the site quality, and reduce the audit findings year by year. 定期巡查车间现场，记录等并有针对性的优化改善现场质量，逐年降低审计发现项。
Qualifications 任职资格 61 Major in Pharmaceutics, Pharmaceutical Science or related field; 药剂学、药学或相关专业； 61 Minimum of 8~10 years, MS degree with a minimum of 4~8 years or Ph.D. degree with a minimum of 3~4 years of experience in pharmaceutical manufacturing; 8～10年以上工作经验，4～8年以上硕士学位或3～4年以上制药经验的博士学位； 61 Experience in managing at least 4~6 staff across extended shift operations; 有管理4-6名员工的经验； 61 Expert knowledge and hands-on experience in harvest, purification, virus clean and bulk filling including MAbs and/or recombinant proteins; 具备收获、纯化、病毒清除和原液分装（包括单克隆抗体和/或重组蛋白）方面的专家知识和实践经验； 61 Advanced computer system skills for Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook); 熟练掌握Microsoft Office套件（Word、Excel、PowerPoint、Project、Outlook）的高级计算机系统技能； 61 Advanced practical experience of Good Manufacturing Practice including NMPA, PIC/S, and US-FDA guidelines with focus on biologic drug product manufacture for clinical trials and commercial. 良好生产实践经验，包括NMPA、PIC/S和US-FDA指南，重点是临床试验和商业用生物药品的生产。 61 Design and selection, installation, start-up, and validation of downstream equipment and facilities; 下游设备和设施的设计和选择、安装、启动和验证； 61 Previous hands-on experience in large-scale manufacture of drug substance; 有大规模生产原料药的实践经验； 61 Responsibility for representing manufacturing operations for drug substance at Agency (NMPA, US-FDA, EMA or similar) and/or customer audit; 负责在机构（NMPA、US-FDA、EMA或类似机构）和/或客户审计中代表原料药的生产运营； 61 Selection and management of Contract Manufacturing Organization (CMO) for purification services; 为（CMO）项目提供纯化的服务； 61 Experience in process transfer and validation for BLA; 具备BLA的工艺转移和验证经验； 61 Project management training; 项目管理培训经验 61 Formal root-cause analysis; 根本原因分析的能力 61 Use of enterprise software platforms including eQMS and ERP. 使用企业软件平台，包括eQMS和ERP。
