1、According to the company's overall development strategy and R & D strategy, responsible for the progress tracking and coordination of the whole process from formulation development to production transfer, solving technical problems encountered in the process, organizing the forces of technical research to be responsible for the completion quality of the project.
2, Grasp the development trend and dynamics of formulation technology research, participate in project establishment, formulate formulation R&D project plan, and supervise the implementation of the plan.
3, Responsible for drug formulation prescription screening, process research and optimization, and realize the transformation to pilotscale experiment and large production.
4、Responsible for the overall coordination arrangement of the work related to the domestic registration of drugs, the authenticity, completeness and accuracy check and audit of the declaration materials, diagrams, original records, etc..
5、Participate in the corresponding project introduction assessment and CRO cooperation, responsible for the equipment required for the preparation project test, material procurement review and approval.
1、Master's degree or above in pharmacy related majors; more than 3 years of experience in management of formulation R&D team.
2, More than 8 years of experience in formulation R&D, experience in product registration and drug declaration projects, experience in innovative drugs is preferable.
3、Familiar with formulation R&D management, with rich experience in dosage form improvement, technological scale up, analytical R&D. Experience in tablet R&D in large domestic and foreign pharmaceutical companies is preferred.
4、Familiar with the relevant policies and regulations of drug development and registration, national new drug approval technical requirements and review trends, with multiple projects successfully developed to complete the declaration of production experience is preferred.
5、Good at organization and coordination, communication, and have excellent listening, speaking, reading and writing skills in Chinese and English.