锦鲤求职岗位描述
1. 最低任职要求Minimum Requirement
教育程度/经验Education background/ Experience:
本科及以上学历，生物学，药学等相关学科。具备一定的生物制剂（尤其是小容量注射剂）的研发或生产经验。具有基本的GMP常识并熟知药物制剂（尤其是水针和冻干制剂）的生产工艺流程。
University or above with majority in biology or pharmacy or equivalent. Have certain experience of DP(especially small volume parenteral)development and manufacturing. Have the basic GMP and Drug product (especially injection and lyophilized product) manufacturing process knowledge
其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)
对制剂配液和无菌灌装以及冻干工艺有较深的认识。
Well known DP formulation and aseptic filling, as well as lyophilization process.
对GMP法规要有一定的了解和理解
Have certain understanding of GMP regulations
善于跨部门沟通和团队协作
Good at cross function communication and teamwork
能灵活调整时间，支持海外基地的工作。
Ability to work flexible hours to support overseas operations (accommodating different time zones as needed.
英语技能（阅读、写作、口语、听力）优异者。
Excellent English skills (reading, writing, speaking, listening).
有海外留学经验者，可适当放宽工作经验要求。
Candidates with overseas study experience may be given more flexibility in the work-experience requirements.
2. 工作职责JOB RESPONSIBILITY
项目转移：负责制剂工艺的技术转移，与DPD紧密沟通工艺转移相关的关键参数的确认，物料准备等，如涉及客户转移工艺，负责支持Gap分析与客户的沟通。与工艺研发部门，质量保证，质量控制等部门有效沟通以支持项目工艺转移，确认相关取样方案，协调生产工艺。
Responsible for drug product process technology transfer, including close collaboration with DPD to confirm critical process parameters, material readiness, and other transfer-related requirements. When client-led process transfer is involved, provide support for gap assessments and client communications. Effectively coordinate with Process Development, Quality Assurance (QA), Quality Control (QC), and other cross-functional teams to support successful process transfer activities. Confirm sampling strategies, coordinate manufacturing processes, and ensure smooth execution of technology transfer activities.
文件撰写和项目执行: 起草和修订项目相关的BOM，批记录，工艺流程图，方案等：掌握工艺转移及项目的状态，工艺转移中的挑战和进展及后续计划，并向客户汇报:确认生产物料信息，协助物料组进行生产物料的领用与采购：领导项目实施，确保客户及工艺转移讨论过程中的要求被有效传递到运营团队。
Document writing and project execution: draft and revise BOM, batch records, process flow charts and plans related to the project; master process transfer and project status, challenges and progress in process transfer and follow-up plan, and report to customers; confirm production material information, assist material group to receive and purchase production materials: Lead project implementation and ensure requirements from customer and process transfer discussions are effectively communicated to the operations team.
项目总结：负责项目生产BPR的核查，数据整理，相关附件收集工作：负责项目报告的撰写。
Project summary: Be responsible for reviewing the BPR, data compilation and collection of relevant attachments: Be responsible for writing of project reports.
项目的偏差、变更、CAPA、OOS管理：负责组织处理项目相关的变更、偏差、CAPA、OOS：跟踪项目相关的偏差调查、变更控制、纠正预防措施、OOS的进展情况，及时与客户保持沟通。
Management of project deviation, change, CAPA and OOS: Be responsible for handling the project related change control, CAPA and OOS: Follow up the progress of deviation investigation, change control, CAPA and OOS of related project and communicate with client timely.
其他：支持客户审计，协调项目相关工艺设备的安装和测试/验证等：关注生物制药行业的前沿动态，为新的扩张项目的技术方案提供信息。
Others: Support client audit, coordinate the installation and testing/validation of project-related process equipment： Understand the trend of biopharmaceutical industry, and provide updated information of technical approaches for new expansion project.