About this role
<p><strong>岗位职责：</strong></p> <ul> <li>熟悉厂房设施、工艺流程、技术转移及PPQ（工艺性能确认）所需知识要点；</li> <li>Familiar with knowledge related to facilities, process flow, tech transfer and PPQ (Process Performance Qualification).</li> <li>主导日常生产管理，包括偏差调查、纠正预防措施（CAPA）、变更控制及技术方案/报告的撰写/审批；</li> <li>Lead daily manufacturing management, including deviation investigations, Corrective and Preventive Actions (CAPA), change control, and draft/approval of technical plans/reports</li> <li>PPQ阶段担任工艺负责人，推动持续工艺优化与验证工作；</li> <li>During PPQ stage, serve as the process owner and drive continuous process optimization and validation work.</li> <li>支持向不同CDMO或生产基地的跨国技术转移；</li> <li>Support cross-border tech transfer to different CDMOs or production sites.</li> <li>与所有相关部门紧密合作，确保项目按计划推进；</li> <li>Collaborate closely with all relevant departments to ensure projects progress as planned.</li> <li>做好MSAT上游人才培养工作。</li> <li>Conduct MSAT upstream talent development and training work.</li> </ul> <p> </p> <p><strong>任职要求：</strong></p> <ul> <li>本科及以上学历，生物工程、发酵工程、细胞生物学、分子生物学等相关专业</li> <li>Related degrees in Bioengineering, fermentation engineering, cell biology, molecular biology</li> <li>熟悉GMP生产，具有技术转移和工艺验证相关经验；</li> <li>Familiar with GMP production, with experience in tech transfer and process validation.</li> <li>拥有生物制药MSAT/PD相关经验；</li> <li>Drug product experience of MSAT/PD in biopharmaceuticals.</li> <li>能够熟练阅读和撰写中英文技术文件；</li> <li>Ability to read and write technical documents in both Chinese and English.</li> <li>具备基础的英语沟通能力</li> <li>Basic English communication skills.</li> </ul>