Project Management 项目管理
61 Independently responsible for the project management of all kinds of projects：
独立负责各类项目的项目管理工作：
61 Responsible for coordination of multi-disciplinary team to achieve project goals, including timeline, budget and deliverables;
负责协调项目团队以达成包括时间表、预算和交付物在内的项目整体目标；
61 Set and monitor the project plan including decision gate and milestones together with the internal project team and generate project updates for client;
与内部项目组一同对项目计划中的关键决策节点和里程碑进行监督，并为客户整理项目进展；
61 Prepare and hold project meetings including issuing of agenda, action items, and meeting minutes;
准备并主持项目会议，包括制定议程，行动项和整理会议纪要；
61 Take charge of order quotation filing, contract and supplementary agreement draft writing；
负责订单的报价文件整理，合同及补充协议初稿撰写；
61 Complete project related work, such as delivery, material settlement expense check, internal process application, etc；
完成项目相关工作，例如发货，物料结算费用核对，各项公司内部流程申请等；
61 Responsible for client relationship management and ensuring client satisfaction throughout the life of the project execution;
负责客户关系管理，并保证客户在整个项目执行过程中能够满意；
61 Travel to clients or conferences will be required from time to time;
有时可能需要出差拜访客户或参加会议
Site Safety and Environmental compliance 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 质量保证
61 Comply with the Company Quality Management System.
遵守公司制定的质量管理体系。
61 Contribute to writing Quality Management System documentation for project management processes and procedures.
需要参与撰写项目管理流程和步骤相关的质量管理体系文件。
General常规要求
61 Maintain effective, collaborative, and frequent interactions with other department to ensure harmonization in scientific and technical approaches;
与其他部门保持有效、协作和频繁的沟通，以确保科学和技术方法的协调；
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。

Qualifications 任职资格
Educational Background 教育背景
61 Bachelor’s degree or above in Biochemistry, Biochemical Engineering, Bioprocessing or related field.
生物化学、生物化工、生物工艺过程或者其他相关专业学士学位及以上。
Essential Experience 必要经验
61 At least 3 year of biopharmaceutical project management experience for master degree，5 years for bachelor degree.
全日制硕士相关领域工作3年及以上；本科学历，大分子生物领域工作5年及以上。
61 Basic knowledge in biologics CMC development.
在生物药的CMC开发方面具备基础的知识；
61 Previous experience in project management to deliver investigational medicinal products (IMP) and/or dual IND filing in China and USA or Europe;
具备交付临床研究用医药产品的项目管理经验和/或在中国，美国或者欧洲递交双语IND申报的经验；
61 Advanced computer system skills for Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook).
熟练使用Microsoft Office办公软件（Word、Excel、Powerpoint、Project、Outlook）。

Preferred Experience 优先考虑
61 Advanced postgraduate qualification (BS, MS or PhD) related to biopharmaceutical development;
具备生物医药研发相关的高级学位（学士，硕士或博士）；
61 Sound knowledge of Good Manufacturing Practices including NMPA, ICH, and US-FDA guidelines with focus on biologic products;
在GMP方面具备全面的知识，包括NMPA，ICH和US-FDA发布的针对生物制品的相关指导原则；
61 Hands-on experience on the dossier preparation for IND or BLA filing;
具备IND或BLA申报相关文档的撰写经验；
61 Formal qualification in project management， e.g. PMP certification.
具备官方认证的项目管理资质，例如，持有PMP证书；