岗位职责:

1.负责指定项目开发策略及计划。

Responsible for specifying project development strategies and plans.

2.负责制定生物偶联工艺开发阶段性目标，拆解工作任务并合理安排组员进行工作。

Responsible for formulating stage goals of coupling process development, dismantling work tasks and reasonably arranging team members for work.

3.完成工作总结及汇报，完成制药工艺开发过程中各方案制定、撰写及执行，完成后报告撰写。

Complete the work summary and report, complete the formulation, writing and implementation of various plans in the process development process, and write the report after the completion.

4.能独立负责偶联工艺开发，并协助放大生产。

Independently responsible for the development of coupling process and assist in the scale-up of production.

5.完成偶联相关项目管理和申报，确保符合注册法规与行业趋势。

Complete the management and application of coupling related projects to ensure compliance with registration regulations and industry trends.

6.负责偶联研发成本的核算。

Responsible for the cost accounting of coupling research and development.

7.负责管理、维护保养检验设备，确保检验设备可正常运行且在有效期内。负责新设备的安装、调试、校准、确认以及设备档案的建立工作。

Responsible for the management and maintenance of the inspection equipment to ensure that the inspection equipment can operate normally and within the validity period. Responsible for new equipment installation, debugging, calibration, validation and equipment file establishment.

8.完成领导分配的其他工作和职责。

Complete other tasks and responsibilities assigned by the leader.

9.负责保证所有的活动符合GMP/GLP的要求。

Be responsible for assuring that all the activities are in line with GMP/GLP requirement.

10. 负责保证所有的检测活动符合公司和总部的EHS方针和要求，确保检测的环境是安全的，人员的保护设备能按要求正确地使用。

Be responsible for assuring that all the testing activities are in line with the company and corporate EHS policies and requirements. Make sure that the production environment is safe and personal preventive equipment properly used as required.

任职要求:

1. 至少五年以上从事生物制药偶联相关工作（至少包括ADC）的实践经验。

At least 5 years of practical experience in coupling related work (including ADC at least).

2. 能够阅读相关的英文资料。

Be able to read related English materials.