工作职责：
1. XDC技术转移
Technical transfer to XDC
1.1 作为生产技术转移接收方，与工艺技术转移方或客户进行差距分析并完成技术转移工作。并及时就项目技术转移状态与CMC 团队协调并沟通，项目状态包括但不限于技术转移情况、技术挑战和物料准备情况，产品的中控及放行质量标准。
As the receiving side of manufacturing, perform the gap analysis and finish the technology transfer work together with the sending side or client. Coordination and communication with CMC team in time regarding the status of the project, include but not limited to: technical transfer status, technical challenges, materials preparation, in-process control testing and product release specification.
1.2 撰写并及时更新项目相关文件，包括但不限于变更、工艺流程、方案、主生产记录、取样计划、物料清单以及法规申报文件。
Create and keep project related documentation updated, include but not limited to: Change control, process flow diagram, manufacturing protocol, master batch record, sampling plan, bill of materials and RA documents.
1.3 将项目的最新进展及时更新给客户和CMC团队，并针对工艺和技术话题与客户进行沟通协调。
Keep client and CMC team updated on project progress. Communication and coordination with client regarding process and other technology topics.
1.4 就工艺转移、确认和生产的执行与偶联、制剂、QA、QC及研发部门进行协调。
Coordination with BCM, FFF, QA and QC departments regarding to process transfer, qualification and production execution.
2. 物料管理
Material management
2.1 追踪物料的采购进展以及新物料的来源确认。确保项目所需物料的在生产前准备就绪。
Follow-up the material procurement process and source confirmation for new materials. Ensure the readiness of the existing materials as per the project requirement prior to the manufacturing.
2.2 支持生产部门实施购买和接收流程。
Support the production department to implement purchasing and receiving procedure.
3. 项目实施
Project implementation
3.1 领导项目的实施并且保证客户在工艺转移过程中提出的要求被明确地传达给生产团队。
Lead the implementation of project and ensure client requirements discussed during technical transfer are clearly conveyed to production team
3.2 发起并跟进生产、QC检测、样品转移更新。保证客户、PM和CMC Leader及时获得项目进展情况更新。
Initiation and follow-up the production, QC testing, sample transfer updates. Keep client, PM, and CMC lead updated of project progress.

任职要求：

应届研究生/本科具有二年行业相关工作经验
Fresh Master degree/ Bachelor with two years of relevant working experience.
有制药行业知识和经验：制剂生产或/和研发、工艺验证相关的经验优先。
With pharmaceutical knowledge, experience with finished drug product manufacturing or/and R&D or/and process validation is preferred.
流利的英文听说能力、网络通信软件、办公软件的使用能力。
Fluent English listening and speaking skills and ability to use internet communication and office software.
良好的沟通和团队合作能力。
Satisfied technical communication skill and team work ability
能灵活调节时间，满足工作要求
Flexible with the working time as required.