Job Purpose (State briefly the overall objective of the job)

Respoible for the technical management of chemical processes assigned to him/her under supervision. Supports the scale-up/commercial production and coaches production people in matrix organization. Eure deliveries, HSE, GMP targets for his/her processes.

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负责所赋予化学工艺的技术管理，支持放大和商业化生产并指导培训生产人员，保证所负责工艺HSE GMP目标的实现和各种交付。

Basic Major Activities (Describe main activities)

1.Point of contact for process support for manufacturing， Coult with process chemist in R&D, prepare and execute master batch record.

作为生产工艺支持的主要联系人，和研发化学师协商,完善和执行车间主批记录。

2.Plan, organize & prepare equipment trai, raw materials and other production facto (e.g. mass balance sheet, PFD, Hazard analysis, coordinate IPC with R&D) for manufacturing of intermediates and drug substances

计划，组织和准备设备反应链，反应原料和其他原料药中间体及原料药生产相关因素（例如准备物料平衡图，工艺流程图，风险分析，和工艺研发部协调中控事宜等）。

3.Execute processes according to batch strategy. Comply with SOP, HSE, and other guidelines

在合乎SOP（标准操作规程），HSE（安全环保健康）等规程的条件下，根据工艺操作规程执行工艺。

4.Interact with R&D project teams and influence process development in order to guarantee feasibility and reliability of scale-up/commercial production.

能和工艺研发部项目组积极沟通反馈，支持工艺研发过程，以保证工艺放大/商业化生产的可行性和可靠性。

5.Coistently lead, advice, and guide manufacturing team in the day to day process operatio assigned for assigned processes.

一如既往地指导和带领相应的操作团队执行相关工艺的日常生产工作。

6.Fully respoible for complex equipment and systems independently

能独立负责较为复杂的工艺设备和系统。

7.Eure training to manufacturing team on assigned processes

确保生产团队得到相关工艺的培训。

8.Equipment and process troubleshooting

设备和工艺中出现问题的解决。

9.Provide process improvement suggestio，Interpret process observatio in order to identify potential improvements for ongoing process development

提供优化工艺的建议，在整个生产过程中时时观察/理解工艺现象，以便更好为可能的工艺改进提供建议。

10.Eure waste management in accordance with internal & external regulatio (Exhaust air, effluent, liquid & solid waste)

在合乎内部和外部的管理规定的前提下确保废弃物管理流程的执行（废气，废液和废固）。

11.Eure reassembling & cleaning of equipment trai after manufacturing

在生产活动结束后确保设备链复位及清洗。

12.Eures proper and compreheive batch record. Guide manufacturing team accordingly

确保生产批记录填写的完整性和正确性，对生产团队提供相应的指导。

13.Perform internal Batch Record Review incl. deviatiochange assessment for QA approval .Complete campaign report in a timely manner.

审阅生产批记录（包括偏差/变更评估部分）。生产结束后及时完成生产总结报告。

14.Contribute to continuous plant optimization and process improvements initiatives对车间设备及工艺的持续优化有所贡献

15. Actively contributes to keeping the plant properly maintained and clean

积极参与车间维护和保洁。

16.Interacts with various support functio (e.g. warehouse & logistic, manufacturing officer) in order to guarantee smooth batch execution

积极和不同职能进行沟通（如，仓储物流，生产主管等）以确保批次生产的顺利进行。

17.Regularly update Planning & Scheduling on the progress on the assigned tasks to facilitate resource allocation pla.

定期沟通项目生产最新进展以便及时制定最新车间生产资源分配计划。

18.Acts as point of contact for emergency respoe teams as appropriate.

根据需要，作为紧急响应团队的联系人。

19.Check all the infrastructure related facilities during operation as appropriate

根据需要，检查车间公用工程系统以保证生产顺利进行。

20.Can take project specific the role as Expert Process

可根据工艺特殊需要担任高级工艺专家的角色。

21.Various respoibilities in accordance to GMP HSE respoibility/deliverable

以及其它GMP,HSE相关的职责/交付。

Key Performance Indicato (Indicate how performance for this job is measured)

Quality (GMP), quantity, and timelines for all assigned tasks/projects保质保量完成分配的任务

Compliance with standards, in particular, ethics, health, safety, and environment (HSE).合规，特别是在职业道德，健康，安全环境保护方面的合规

No LTA (lost time accident), RFT (right fit time), Rework/reprocess Rates, deviatio, batch failure.无损失工时的事故，一次成功率，再加工/返工率，偏差,失败批等

Ideal Background (State the required education and experience levels)

Education (minimum/desirable): Formal education in organic synthesis related

与有机合成相关的教育

Languages:English preferred 有英语基础优先

Experience/Professional requirement:

1.Apprenticeship， or yea of practical experience in organic chemical / pharmaceutical industry or related experience in field of expertise有有机合成经验

2.Adequate IT application know how to fulfill role (ie word excel, drawing tools...)熟练使用电脑

3.Good knowledge of HSE/GMP standards and processes preferred有HSE GMP 经验优先