制剂研发Pharmaceutical Formulation development Researcher(J13560)

工作职责 1. 负责制剂研发项目的管理，组织/审核研究方案，并组织落实方案内容，整合资源，对RLD处方进行解析； 2. 负责中试放大，协助制定、审核并落实工艺验证方案，协调资源进行工艺技术及资料移交； 3.进行新药或者仿制药的研发、一致性评价、针对制剂研发提供QbD/DoE方案、解决在项目过程中出现的处方/工艺/放大等问题； 4. 熟悉并及时了解CFDA和FDA的各项相关法规的动态、从分析检测结果中找到处方和工艺筛选的方向； 1. Be responsible for pre-formulation study, such as the physical and chemical properties of API and reference listed drug, API and excipients compatibility, to be basis of formulation development. 2. Prepare for scale up and technology transfer of formulation process. For different equipment and batch size, confirm adjustment plan, ensure the scale up and transfer economically and efficiently. 3.Preparation for formulation and process screening according to QbD/DoE, ensure laboratory batch samples satisfy the established standards. 4.Familiar with all regulations and guidelines relevant to formulation. 任职资格 1、硕士学历，药学、药剂学相关专业 2、课题为固体制剂、注射剂、复杂制剂、药物递送研发、制剂分析检测等相关 Master's degree, majoring in Pharmacy, Pharmaceutics or related disciplines With R&D experience in solid preparations or injections