工作职责

 Responsible for solid formulation development of small molecules drug discovery for IND/NDA submission and clinical stage supplies.
 Responsible for managing a high performance formulation team. Key activities include formulation design and development, project management, performance evaluation, project status updates, and exceeding customer expectations.
 Standardize the R&D procedure, improve the project management system, and effectively balance the quality, progress and cost.

工作要求

 Master or above major in pharmaceutical sciences or relevant discipline, with a strong scientific track record.
 10+ years of relevant industrial experience in small molecules drug discovery for oral solid.
 Successful track record in IND/NDA drug product development while operating within aggressive timelines.
 In-depth understanding of the pharmaceutical R&D process.
 Experience with different dosage forms, scale-up process of clinical supplies.
 Familiar with regulatory requirements, GMPs and ICH guidelines, etc.
 Hands-on operational manager.
 Flexible and innovative problem solver.

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岗位职责：

1、制剂处方筛选；

2、制剂工艺参数选择及优化；

3、制剂开发报告编写；

4、编写CTD资料（制剂部分）；

5、工艺的技术转移；

6、实验室设备的使用、维护及校验SOP起草。

经验要求：

1、5年以上相关工作经验，熟悉固体制剂的处方和工艺的开发；

2、能够熟练操作固体制剂常用设备（如湿法制粒机、流化床、压片机和胶囊填充机等）；

3、熟悉CFDA和FDA注册法规和指导原则的相关要求；

4、熟练使用office等办公软件；

5、硕士及以上学历。