Hengrui Pharma
主要职责：
项目技术转移
主导多个生物药项目（涵盖上游培养、下游纯化、制剂灌装）的技术转移全流程，制定分阶段策略并监督执行。
审核技术转移文件（工艺描述、风险评估、分析报告），组织跨部门（PD、生产、QA/QC）会议以确保技术细节有效落地。
起草核心文件（差距分析、转移方案、总结报告），并全程跟踪物料、设备、工艺规程等关键节点。
负责解决转移过程中的偏差与变更（Deviations/Change Controls），推动根本原因分析（RCA）与CAPA制定。
技术支持
为商业化生产提供工艺优化建议，参与复杂偏差调查及工艺验证（PPQ）
注册申报支持 撰写BLA/NDA申报资料（如CMC模块、工艺验证报告），支持全球监管机构问询。 参与工艺变更的法规影响评估，确保符合FDA/EMA/NMPA要求。 任职资格： 教育背景 生物工程、制药工程、分子生物学、药剂学等相关领域
博士学位
。 相关经验 研究方向与
生物药工艺开发
（如细胞培养、蛋白纯化、制剂稳定性）或
GMP生产
相关者优先。 发表过相关领域SCI论文或专利者优先。 有生物药企业实习或学术合作项目经验（如中试生产、工艺放大）者优先。 专业技能 了解生物药生产工艺（哺乳动物细胞培养、层析、超滤/透析、无菌灌装）及关键质量控制点。 掌握技术转移方法论（如风险评估工具FMEA、质量源于设计QbD）。 了解GMP/ISO法规，有工艺验证或申报资料撰写经验者更佳。 通用能力 逻辑与解决问题：
擅长系统性思维，能通过DOE等工具解决复杂工艺问题。 沟通与协作：
具备优秀的跨文化沟通能力，能清晰地向非技术部门传递技术信息。 抗压与主动性：
能在快节奏环境中高效管理多任务，对行业技术趋势保持敏感。 语言要求 具备优秀的英语听说读写能力，能流畅阅读英文文献并与国际同行进行技术交流。 工作地点 苏州、广州、连云港 Key Responsibilities Lead end-to-end technology transfer for multiple biologics projects (upstream, downstream, fill-finish), defining phase-appropriate strategies and overseeing execution. Review and align cross-functional teams (PD, Manufacturing, QA/QC) on transfer documents including process descriptions, risk assessments, and analytical reports. Draft critical transfer documents such as gap analyses, protocols, and summary reports; track key milestones including materials, equipment, and batch records. Resolve deviations and change controls, drive root cause analysis (RCA), and implement CAPA. Provide process optimization recommendations for commercial manufacturing and support complex deviation investigations and process validation (PPQ). Author BLA/NDA submission documents including CMC sections and process validation reports; respond to global health authority (FDA/EMA/NMPA) queries. Assess regulatory impact of process changes to ensure full compliance. Qualifications Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or related field. Research background in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing. Published papers or patents in related fields (SCI journals preferred). Industry or academic project experience in GMP production or pilot-scale process scale-up. Knowledge of biologics manufacturing processes including mammalian cell culture, chromatography, UF/DF, and aseptic filling; understanding of critical quality attributes (CQAs). Familiar with technology transfer methodologies such as FMEA and QbD; knowledge of GMP/ICH guidelines. Experience in process validation or regulatory writing is a strong advantage. Systematic problem-solving ability with experience using DOE or statistical tools (e.g., JMP, Minitab). Able to clearly convey technical concepts to non-technical stakeholders. Effective in fast-paced environments, skilled at multitasking and managing priorities. Fluent in English (written and spoken); capable of drafting technical documentation and collaborating within global teams. Location Suzhou, Guangzhou, or Lianyungang, China
注册申报支持 撰写BLA/NDA申报资料（如CMC模块、工艺验证报告），支持全球监管机构问询。 参与工艺变更的法规影响评估，确保符合FDA/EMA/NMPA要求。 任职资格： 教育背景 生物工程、制药工程、分子生物学、药剂学等相关领域
博士学位
。 相关经验 研究方向与
生物药工艺开发
（如细胞培养、蛋白纯化、制剂稳定性）或
GMP生产
相关者优先。 发表过相关领域SCI论文或专利者优先。 有生物药企业实习或学术合作项目经验（如中试生产、工艺放大）者优先。 专业技能 了解生物药生产工艺（哺乳动物细胞培养、层析、超滤/透析、无菌灌装）及关键质量控制点。 掌握技术转移方法论（如风险评估工具FMEA、质量源于设计QbD）。 了解GMP/ISO法规，有工艺验证或申报资料撰写经验者更佳。 通用能力 逻辑与解决问题：
擅长系统性思维，能通过DOE等工具解决复杂工艺问题。 沟通与协作：
具备优秀的跨文化沟通能力，能清晰地向非技术部门传递技术信息。 抗压与主动性：
能在快节奏环境中高效管理多任务，对行业技术趋势保持敏感。 语言要求 具备优秀的英语听说读写能力，能流畅阅读英文文献并与国际同行进行技术交流。 工作地点 苏州、广州、连云港 Key Responsibilities Lead end-to-end technology transfer for multiple biologics projects (upstream, downstream, fill-finish), defining phase-appropriate strategies and overseeing execution. Review and align cross-functional teams (PD, Manufacturing, QA/QC) on transfer documents including process descriptions, risk assessments, and analytical reports. Draft critical transfer documents such as gap analyses, protocols, and summary reports; track key milestones including materials, equipment, and batch records. Resolve deviations and change controls, drive root cause analysis (RCA), and implement CAPA. Provide process optimization recommendations for commercial manufacturing and support complex deviation investigations and process validation (PPQ). Author BLA/NDA submission documents including CMC sections and process validation reports; respond to global health authority (FDA/EMA/NMPA) queries. Assess regulatory impact of process changes to ensure full compliance. Qualifications Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or related field. Research background in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing. Published papers or patents in related fields (SCI journals preferred). Industry or academic project experience in GMP production or pilot-scale process scale-up. Knowledge of biologics manufacturing processes including mammalian cell culture, chromatography, UF/DF, and aseptic filling; understanding of critical quality attributes (CQAs). Familiar with technology transfer methodologies such as FMEA and QbD; knowledge of GMP/ICH guidelines. Experience in process validation or regulatory writing is a strong advantage. Systematic problem-solving ability with experience using DOE or statistical tools (e.g., JMP, Minitab). Able to clearly convey technical concepts to non-technical stakeholders. Effective in fast-paced environments, skilled at multitasking and managing priorities. Fluent in English (written and spoken); capable of drafting technical documentation and collaborating within global teams. Location Suzhou, Guangzhou, or Lianyungang, China