制剂研发&分析研究员 Formulation Development & Analytical Researcher(J13581)

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；

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；

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；

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；

Responsible for the management of formulation development projects, organizing/reviewing research plans and implementing the content of the plans, integrating resources and analyzing the formulation of Reference Listed Drugs (RLD).

Responsible for pilot-scale amplification, assisting in the formulation, review, and implementation of process validation plans and coordinating resources for process technology and documentation transfer.

Conduct research and development of new drugs or generic drugs, perform consistency evaluations, provide QbD/DoE solutions for formulation development and resolve issues related to formulation/process/scale-up during projects.

Familiar with and staying updated on the latest regulations of the CFDA and FDA and identifying directions for formulation and process screening based on analytical testing results.

博士学历，药学、药剂学相关专业

博士课题为固体制剂、注射剂、复杂制剂、制剂分析等相关

Ph.D. in Pharmacy, Pharmaceutics, or related fields.

Doctoral research focused on solid dosage forms, injectables, complex formulations, formulation analysis, or related areas.