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微球制剂首席科学家/Microsphere Principal scientist

工作地点:中国         所属类型:GCS-Formulation         发布时间:2020-07-02

岗位描述:

1. 全面负责微球制剂项目组的项目研发及生产放大;

In charge of microsphere R&D team for project R&D and scale up;

2. 制定微球制剂项目组的年度研发计划、组织实施并把控项目进度,完成年度研发任务;

Make the annual R&D plan of microsphere preparation team, organize the implementation and control the project schedule, complete the annual R&D tasks;

3. 负责新产品的立项、评估、设计、研发以及申报;

Responsible for project approval, evaluation, design, R&D and submission of new products ;

4. 指导研发项目实施方案,把控关键进程节点,评估技术瓶颈并提出解决方案,降低项目开发风险;

Guided the implementation plan of R&D project, controlled key process nodes, evaluated technical difficulties and proposed solutions to reduce project development risks ;

5. 指导解决研发过程中以及生产工艺放大转化过程中的重大关键技术问题;

To guide and solve the key technical problems in R&D and production process amplification and conversion;

6. 负责项目的申报,原始记录、CTD资料的审核;

Responsible for project declaration, original records, CTD data audit;

7. 负责研发实验室日常管理以及团队人员的建设与培养;

Responsible for the daily management of R&D laboratory and the construction and training of team members;

8. 上级指派的其他职责.

Other duties as assigned by superior.

任职资格:

1. 博士学历,药学相关专业,8年以上微球剂型药品研发生产工作经验,至少5年以上技术研发团队管理经验;

PhD, major in pharmacy or related field, at least 8 years working experience in R&D and manufacturing of microsphere dosage form, at least 5 years working experience in technical R&D team management;

2. 熟悉药品研发、注册申报全流程,熟悉国家药品技术审评要求、熟悉相关研发技术指导原则、药品注册管理办法、GMP等相关法规文件;

Familiar with the whole process of drug R&D and registration application, national drug technical evaluation requirements, relevant R&D technical guidelines, drug registration management measures, GMP and other relevant regulatory documents;

3. 熟悉微球制剂技术及生产工艺,具备微球制剂产品的生产放大经验,精通药品研发技术理论知识,具备丰富的微球制剂研发及生产经验;

Familiar with microsphere preparation technology and production process, have experience in production amplification of microsphere preparation products, proficient in theoretical knowledge of pharmaceutical research and development technology, and have experience in microsphere research, development and manufacturing;

4. 具有微球GMP生产车间建设经验;

Have the experience of establishing microsphere GMP plant;

5. 具有良好的英语读写能力,能独立查阅、翻译相关文献资料,熟悉国内外的微球制剂研发趋势.

Good English reading and writing skills, able to independently consult and translate relevant literature, familiar with the development trend of microsphere preparations at home and abroad .