Job Responsibility / 岗位职责 1. 生产项目规划与协调 Production Planning & Coordination · 与项目团队紧密合作，收集NPI相关信息，协助制定生产计划、关键里程碑及资源需求。 · Work closely with project teams to collect NPI-related information and support the development of production plans, key milestones, and resource requirements. · 跟踪项目计划执行情况，及时汇总项目进展、风险及待解决事项。 · Track project execution status and summarize project progress, risks, and open actions in a timely manner. 2. 技术转移项目支持 Technology Transfer Support · 协调技术转移相关活动，包括差距分析、生产工艺讨论、生产文件准备及行动项跟踪。 · Coordinate technology transfer activities, including gap assessment, process discussions, manufacturing document preparation, and action tracking. · 清楚了解并跟踪技术转移状态，推动生产相关输入按计划完成。 · Understand and track technology transfer status and drive manufacturing-related inputs according to plan. 3. 生产准备管理 Manufacturing Readiness Management · 负责对所指派项目的生产前准备工作进行跟踪、总结和更新，包括文件、培训、设备、仪器及物料等。 · Track, summarize, and update pre-production readiness for assigned projects, including documents, training, equipment, instruments, and materials. · 协助识别生产准备风险，并推动相关部门及时关闭。 · Support identification of manufacturing readiness risks and drive timely closure with relevant functions. 4. 项目会议与客户支持 Project Meeting & Client Support · 组织生产内部会议，并参与项目外部会议，对生产相关事项进行汇报。 · Organize internal manufacturing meetings and participate in external project meetings to report manufacturing-related matters. · 根据项目需求支持客户来访、现场PIP及远程PIP。 · Support client visits, on-site PIP, and remote PIP based on project requirements. 5. GMP生产过程支持 GMP Manufacturing Execution Support · 跟踪、协调及管理项目生产过程中产生的偏差、变更控制、CAPA以及监管发现项反馈。 · Track, coordinate, and manage deviations, change controls, CAPAs, and responses to regulatory findings arising during project manufacturing. · 与生产团队共同推动问题闭环，保障项目按计划、高质量交付。 · Work with manufacturing teams to close issues and ensure timely and high-quality project delivery. 6. 跨部门资源协调与持续改善 Cross-functional Coordination & Continuous Improvement · 协调MFG内部资源，与项目团队、技术团队、质量及供应链等部门紧密合作。 · Coordinate internal MFG resources and collaborate closely with project teams, technical functions, Quality, and Supply Chain. · 支持PD/MFG技术交流和生产总结，促进生产执行流程持续优化。 · Support PD/MFG technical exchanges and manufacturing summaries to continuously improve production execution processes. 7. 国际学习与实践机会 International Learning and Practice Opportunities · 公司为表现卓越的员工提供海外学习和培训的机会，如在美国、新加坡的相关团队进行实地学习与交流。员工将有机会深入了解国际行业最佳实践、法规标准，并将其应用于现有工作中，为个人发展和组织提升带来助力。同时，这一机会将帮助员工提升跨文化沟通能力与专业技术水平。 · The company offers outstanding employees opportunities for overseas learning and training, such as on-site learning and communication within related teams located in the United States or Singapore. Employees will gain valuable insights into international industry best practices and regulatory standards, applying them to their current work to enhance individual development and organizational performance. This opportunity also aims to help employees improve cross-cultural communication skills and professional expertise. Job Requirements / 任职要求 教育背景 Educational Background · 硕士及以上学历，生物工程、生物技术、药学、制药工程、化学工程、生物制药等相关专业。 · Master’s degree or above in Biotechnology, Biology, Pharmacy, Pharmaceutical Engineering, Chemical Engineering, Biopharmaceuticals, or related disciplines. 英语能力 English Proficiency · 具备良好的英语听、说、读、写能力，能够阅读英文技术文件，并撰写中英文工作报告及项目汇报。 · Good English proficiency in listening, speaking, reading, and writing, with the ability to read English technical documents and present reports and project updates in both Chinese and English. 专业技能 Professional Skills · 了解生物药研发、技术转移、GMP生产或项目管理基本流程；具备培养基/缓冲液配置、细胞培养或蛋白纯化相关知识者优先。 · Basic understanding of biologics development, technology transfer, GMP manufacturing, or project management; knowledge of media/buffer preparation, cell culture, or protein purification is preferred. · 具备较好的逻辑分析、问题解决及数据整理能力，熟练使用Office工具进行项目跟踪和汇报。 · Good logical thinking, problem-solving, and data organization skills; proficient in Office tools for project tracking and reporting. 综合素质 General Competencies · 具备良好的沟通协作能力、团队合作精神和执行力，能够适应跨部门协作和多任务工作环境。 · Good communication, collaboration, teamwork, and execution capabilities; able to work in a cross-functional and multi-tasking environment. · 责任心强，学习能力好，能够接受适度加班和必要的项目支持安排。 · Strong sense of responsibility and learning agility; able to accept appropriate overtime and project support arrangements when needed.