工作内容:
1. 负责吸入液体制剂、滴眼剂等制剂项目的国内外技术动态与法规调研,为立项决策提供科学依据。
Conduct market and technical research on inhaled liquids and ophthalmic formulations, analyzing global trends and regulatory requirements to support project initiation.
2. 主导处方工艺研究方案的制定与实施,完成处方筛选、优化及工艺参数确认。
Design and execute formulation development plans, including screening, optimization, and critical process parameter identification.
3 .解决研发过程中的关键技术问题,确保处方工艺的稳定性与可放大性。
Resolve key technical issues during the R&D process to ensure formulation stability and scalability.
4. 配合生产部门完成中试放大、工艺验证,确保技术转移的顺利实施。
Coordinate with production teams for scale-up process validation to ensure successful technology transfer.
5 .规范记录并整理实验数据与技术资料,并进行合规管理;撰写CTD申报资料,协助完成现场核查。
Standardize the recording and organization of experimental data and technical documents, ensure compliance management; prepare CTD Submission documents, and assist in completing on-site inspections
6. 参与研发体系维护、项目管理及实验室设备日常管理,提升研发效率与合规性。
Participate in the maintenance of the R&D systems, project management, and daily laboratory equipment management to improve R&D efficiency and compliance.
任职要求:
1. 本科及以上学历,药学、制剂或相关专业。
Bachelor’s degree or above in Pharmaceutics, Pharmacy, or related fields.
2. 3年及以上吸入液体制剂或滴眼剂研发经验,至少2个完整成功申报案例(硕士学历可适当放宽)
3+ years of R&D experience in inhaling liquid preparations or eye drops, with at least 2 fully successful submission cases (Master’s degree holders may be considered with slightly less experience).
3. 熟悉吸入制剂/滴眼剂技术指导原则、国内外注册法规(如FDA、EMA、NMPA)及GMP要求。
Thorough understanding of technical guidelines (e.g., FDA, EMA, NMPA) and regulatory requirements for inhaled/ophthalmic products.
4. 具备扎实的制剂理论基础,能独立完成处方开发、工艺优化及设备维护;熟练检索并解读外文文献。
Strong theoretical and practical skills in formulation design, process optimization, and equipment operation; proficiency in literature search and data analysis.
5. 具备良好的跨部门沟通能力、团队协作精神及项目管理意识。
Excellent communication, cross-functional collaboration skills, and project management capabilities.
6. 具备良好的英语读写能力
Good at written and read English.