岗位职责:
1. 负责制剂工艺开发部门、团队建设及管理工作。
Be responsible for the construction and management of the formulation process development department.
2. 负责项目制剂开发策略及计划,及产品使用方式、作用机理、技术指标、技术可行性分析及专利可行性分析。
Be responsible for the formulation development strategy and plan of the project, as well as the analysis of the usage mode, mechanism of action, technical indicators, technical feasibility and patent feasibility of the product.
3. 负责制定制剂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 purification process development, dismantling work tasks and reasonably arranging team members for work.
4. 完成工作总结及汇报,参与并监督工艺开发过程中各方案制定、撰写及执行,完成后报告撰写,对输出结果负责。
Complete the work summary and report, participate in and supervise the formulation, writing and implementation of each plan in the process of process development, write the report after completion, and be responsible for the output results.
5. 能独立负责制剂工艺开发放大,并能协调相关部门完成相关工作。
Independently responsible for the development and amplification of preparation process, and able to coordinate relevant departments to complete related work.
6. 负责与客户对接、交流、汇报工作,保证任务的即时、准确、专业性。
Responsible for communicating, communicating and reporting with customers to ensure the promptness, accuracy and professionalism of tasks.
7. 完成制剂相关项目管理和申报,确保符合注册法规与行业趋势。
Complete preparation related project management and application to ensure compliance with registration regulations and industry trends.
8. 负责制剂研发成本的核算。
Responsible for the cost accounting of preparation R&D.
9. 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.
10. 完成领导分配的其他工作和职责。
Complete other tasks and responsibilities assigned by the leader.
任职要求:
1、微生物学,化学工程,生化工程等理学或生物制药,制药工程等工学学士及以上,硕士优先。
2、至少五年以上从事制剂相关工作(医药固液无菌制剂类工作经验优先)的实践经验。
3、能够阅读相关的英文资料。