Job description

Job responsibilities:

1. Conduct research and risk assessment of the projects undertaken, formulate feasibility plans and research and development plans, and be responsible for the implementation of research work;

2. Responsible for the research on the formulation of the project, the trial production of pilot and pilot samples, and the formulation of key process parameters;

3. Responsible for summarizing and analyzing the research work at each stage and writing technical packages;

4. Responsible for the handover of the prescription process and the quality of the samples produced;

5. Be able to write application materials in CTD format for preparations as required by SFDA;

6. Responsible for the preparations for the on-site inspection and preparation of drug registration.

Job requirements:

1. Major in pharmaceutical preparation or pharmacy, bachelor degree or above, with more than 5 years of relevant work experience;

2. Familiar with the use of commonly used preparation research and development equipment (such as mixers, granulators, fluidized beds, tablet presses, etc.), and understand the use of commonly used analytical testing instruments;

3. Familiar with drug research and development process, master the professional knowledge of drug preparation research and development, quality control, workshop production, etc.;

4. Working experience related to controlled release is preferred;

5. Have good English reading and writing skills, able to independently consult and translate related documents;

6. Honesty, integrity, strong sense of responsibility, good team spirit and cooperative spirit.