XDS_MSAT工艺技术工程师（技术转移方向）*3

ensures that client process

are accurately translated into executable, controlled, and GMP-compliant manufacturing solutions. 工作职责 / Key Responsibilities

1. 01

   负责抗体及偶联药物项目的工艺技术转移，参与新项目引入和技术可行性评估，识别工艺、厂房、设备、物料、分析及生产执行方面的差距和风险，并制定相应的技术转移计划及风险控制措施。 Responsible for process technology transfer for antibody and bioconjugation projects. Participate in new product introduction and technical feasibility assessments, identify gaps and risks related to process, facility, equipment, materials, analytics, and manufacturing execution, and develop appropriate transfer plans and risk controls.

2. 02

   根据项目范围和时间计划，组织或参与客户技术资料接收、差距分析及技术澄清，确保工艺知识、关键工艺参数、关键质量属性、控制策略、历史偏差和工艺经验得到充分理解、记录并传递。 Organize or participate in the receipt, gap assessment, and clarification of client technical information according to project scope and timeline. Ensure that process knowledge, critical process parameters, critical quality attributes, control strategy, historical deviations, and process experience are adequately understood, documented, and transferred.

3. 03

   负责或协调完成技术转移相关文件，包括但不限于Facility/Process Fit、GARA或其他工艺风险评估、BOM、PFD、SPL、工艺参数清单、取样计划、生产工艺说明、MBR、技术转移方案、技术转移报告及生产总结报告，并确保不同文件之间内容一致、可追溯。 Author or coordinate technology transfer documents, including but not limited to Facility/Process Fit assessments, GARA or other process risk assessments, BOMs, PFDs, SPLs, process parameter lists, sampling plans, manufacturing process descriptions, MBRs, technology transfer protocols, technology transfer reports, and campaign summary reports. Ensure consistency and traceability across documents.

4. 04

   组织并跟踪GMP生产准备工作，包括物料、设备、设施、公用系统、生产文件、分析方法、取样、人员培训及支持性研究等；支持生产准备清单或PT清单确认，识别准备差距并推动按项目时间要求关闭。 Coordinate and track GMP manufacturing readiness, including materials, equipment, facilities, utilities, manufacturing documents, analytical methods, sampling, personnel training, and supporting studies. Support confirmation of manufacturing readiness or PT checklists, identify readiness gaps, and drive timely closure in line with the project schedule.

5. 05

   为工程批、临床批、工艺确认批及其他GMP生产活动提供现场技术支持，确认工艺要求得到正确执行，及时识别和协调解决生产过程中的技术问题，并推动必要的升级、决策和行动项关闭。 Provide shop-floor technical support for engineering, clinical, process confirmation, and other GMP manufacturing batches. Confirm that process requirements are correctly executed, promptly identify and coordinate resolution of technical issues, and drive necessary escalation, decision-making, and action closure.

6. 06

   负责或参与项目相关偏差、变更、风险评估及技术问题调查，开展工艺影响评估、根因分析和科学论证，制定或支持CAPA，并评估质量事件对后续生产、技术转移状态及项目交付的影响。 Lead or participate in project-related deviations, changes, risk assessments, and technical investigations. Perform process impact assessments, root cause analysis, and scientific justification; define or support CAPAs; and assess the impact of quality events on subsequent manufacturing, transfer status, and project delivery.

7. 07

   负责项目技术接口和跨职能协同，与客户、CMC、生产、QA、QC、工程、供应链、工艺开发及项目管理等团队保持有效沟通，定期更新项目进展、关键风险、待决策事项和交付状态，确保客户技术要求被准确传递至生产团队。 Act as a project technical interface and collaborate across functions, including clients, CMC, Manufacturing, QA, QC, Engineering, Supply Chain, Process Development, and Project Management. Provide regular updates on progress, key risks, pending decisions, and deliverable status, and ensure that client technical requirements are accurately communicated to the manufacturing team.

8. 08

   支持项目由技术转移阶段向工艺验证及商业化生产阶段的顺利衔接，向工艺验证或商业化支持团队提供完整的工艺知识、关键风险、控制策略、历史问题及未完成事项，支持后续PPQ准备、持续工艺确认和生命周期管理。 Support effective transition from technology transfer to process validation and commercial manufacturing. Provide process validation or commercial support teams with complete process knowledge, key risks, control strategy, historical issues, and open items, and support subsequent PPQ readiness, continued process verification, and lifecycle management.

9. 09

   负责或支持IND/BLA等申报资料中与生产工艺和技术转移相关内容的撰写、审核及技术信息核对，确保申报内容与已批准工艺文件、实际生产执行和项目数据保持一致。 Author, review, or verify manufacturing process and technology transfer content for IND/BLA or other regulatory submissions. Ensure consistency among submission content, approved process documents, actual manufacturing execution, and project data.

10. 10

    作为项目或工艺主题专家支持客户审计、客户拜访、PIP、Mock audit及NMPA、FDA、EMA等官方检查，准备工艺策略、关键文件、数据和科学论证，并支持审计问答、缺陷评估及整改。 Serve as a project or process subject matter expert to support client audits, client visits, PIP activities, mock audits, and NMPA, FDA, EMA, or other regulatory inspections. Prepare process strategies, key documents, data, and scientific rationale, and support audit responses, observation assessment, and remediation.

11. 11

    参与技术转移平台、SOP、模板、检查清单、知识库和培训体系的建立及持续优化，沉淀项目经验，推动技术转移流程标准化、风险管理前置、文件质量提升及最佳实践复用。 Contribute to the development and continuous improvement of technology transfer platforms, SOPs, templates, checklists, knowledge bases, and training systems. Capture project learning and promote process standardization, proactive risk management, document quality, and reuse of best practices. 任职要求 / Qualifications

12. 01

    硕士研究生及以上学历，化学工程、生物工程、生物学、生物化学、药学、制药工程或其他生命科学相关专业。 Master’s degree or above in chemical engineering, bioengineering, biology, biochemistry, pharmacy, pharmaceutical engineering, or another life-science-related discipline.

13. 02

    优先考虑具有3年以上抗体、大分子药物或偶联药物工艺开发、技术转移、工艺放大、GMP生产支持或MSAT相关工作经验的候选人；具有完整技术转移项目经验者优先。 3+ years of experience in process development, technology transfer, scale-up, GMP manufacturing support, or MSAT for antibodies, biologics, or bioconjugates is preferred. End-to-end technology transfer project experience is a strong advantage.

14. 03

    理解抗体或偶联药物生产工艺、工艺放大、控制策略、关键工艺参数和关键质量属性，能够识别技术转移过程中的工艺、设备和生产执行风险。 Understanding of antibody or bioconjugation manufacturing processes, scale-up, control strategy, critical process parameters, and critical quality attributes, with the ability to identify process, equipment, and execution risks during technology transfer.

15. 04

    熟悉GMP要求及技术转移相关文件和流程；具备Facility/Process Fit、工艺风险评估、BOM、PFD、SPL、MBR、取样计划、技术转移方案或报告等文件经验者优先。 Knowledge of GMP requirements and technology transfer documentation and processes. Experience with Facility/Process Fit assessments, process risk assessments, BOMs, PFDs, SPLs, MBRs, sampling plans, or technology transfer protocols and reports is preferred.

16. 05

    具备偏差调查、变更评估、风险评估和问题解决能力，能够基于数据和科学原理开展影响评估、根因分析并形成清晰的技术结论。 Ability to support deviation investigations, change assessments, risk assessments, and troubleshooting, and to use data and scientific principles to perform impact assessment, root cause analysis, and develop clear technical conclusions.

17. 06

    具备良好的项目管理和执行能力，能够在多项目并行及紧迫时间计划下明确优先级、跟踪关键路径、识别风险并推动跨部门行动按时关闭。 Strong project management and execution skills, with the ability to prioritize across multiple projects and demanding timelines, track critical paths, identify risks, and drive timely closure of cross-functional actions.

18. 07

    具备良好的跨部门沟通、会议组织、技术汇报和客户沟通能力，能够清晰传递复杂技术信息并推动相关方达成一致。 Strong cross-functional communication, meeting facilitation, technical presentation, and client communication skills, with the ability to clearly convey complex technical information and align stakeholders.

19. 08

    具备良好的中英文读写及口语沟通能力，能够独立撰写和审核中英文技术文件，并使用英语与国内外客户开展技术沟通。 Strong written and spoken Chinese and English, with the ability to independently author and review bilingual technical documents and communicate technical topics with domestic and global clients.

20. 09

    责任心强，逻辑清晰，具备主动学习、风险意识、团队合作和问题解决能力，能够适应生产现场支持及项目关键阶段的工作安排。 Strong ownership, logical thinking, learning agility, risk awareness, teamwork, and problem-solving capability, with flexibility to support shop-floor activities and critical project phases.