1. Lead and participate in formulation and drug product (DP) process development and stability assessment activities for biological drugs, such as mAb, bispecific antibodies, recombinant proteins, etc.
2. Independently screen and optimize the formulation and drug product process of different dosage forms based on a comprehensive physicochemical knowledge of therapeutic drugs according to domestic and international quality requirements and GMP requirements;
3. Establish drug product process from pilot scale to commercial scale
4. Develop the stability program for different products, in different stages
5. Develop fit-for-purpose analytical methods to support biophysical characterization, formulation and process development, and research stability testing
6. Conduct formulation research and make relevant original records according to relevant specifications, organize and file data, assist and participate in the preparation of declaration data;
7. Laboratory maintenance, calibration, operation and maintenance of formulation equipment shall be carried out and operated according to SOP.
8. Work closely with relevant departments to ensure the smooth progress of the project.
9. Other related work arranged by line Head.
1. Master degree or above in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Chemical Engineering, or related discipline with at least 5 year of pharmaceutical industry formulation development experience;
2. Strong theoretical knowledge and experience with protein chemistry, biochemical characterization of proteins or other biological drugs
3. Hands-on experience and trouble-shooting proficiency with applying chromatographic (HPLC/UPLC), visible and subvisible particle analysis, CE and/or other biophysical technics (DLS, DSC, CD, FTIR, AUC, Fluorescence, Raman spectroscopy) for protein characterization are desirable.
4. Good oral and written communication skills in Chinese and English
5. Active, highly responsible, with team spirit;