Job Description
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