主要职责Main responsibilities 1、开展并完成成药性研究、制剂开发、技术转移以及产品稳定性研究工作。 Participate and complete developability research, formulation research and development, technical transfer and stability study of products. 2、编写相关实验方案、及时填写实验记录、按时完成技术报告。 Be in charge of writing relevant research protocol, filling in experimental records in time, and completing technical reports on schedule. 3、开展辅料、包装材料的选型工作。 Participate in excipients and container closure screening. 4、开展制剂研发范围内的偏差调查、变更控制等工作。 Participate in deviation investigation and change control in the formulation development. 5、完成所负责仪器、设备的选型、URS编写、确认、维护、培训及相关文件的编写工作。 Complete the selection, URS writing, qualification, training and related documentation of the instruments and equipment in charge. 6、应每周一次对实验室现场所负责的仪器SOP进行完好性检查,并记录于实验室现场检查记录中。 The person should check the integrity of SOP in the laboratory site once a week, and record in the laboratory onsite inspection sheet. 7、完成上级指派的其他任务。 Perform other duties delegated by immediate supervisor. 任职资格Job qualification 1、学历:硕士及以上学历,或本科学历且有两年或以上研发经验,并有药学、生物技术、医学方面的专业背景,其他有制剂研发经验及相关经验者也可考虑。 Education background: master degree or above, bachelor degree with two years or more research and development experience in pharmacy, biotechnology or medical science, or others who have pharmaceutical development and relevant experience 2、其他:英语读写熟练,能够熟练查阅外文专业资料。了解GMP及药品注册法规。 Others:Be proficient in reading and writing in English, and be able to read foreign language professional materials. Understand GMP and drug registration regulations.