Job Responsibilities:

1. As the CMC Module Analysis and Formulation Specialist responsible for antibody drug development, I oversee the daily management of the Analysis and Formulation departments, including experimental scheduling and progress coordination.
2. Responsible for the analysis and development of formulation platforms, as well as their continuous improvement, including providing professional training and guidance to subordinate staff.
3. Responsible for quality research on antibody drug products, including the design, development, optimization, and validation of analytical methods; as well as quality analysis and control of products currently in development.
4. Responsible for antibody drug formulation development, stability protocol design, and research.
5. Responsible for preparing IND submission documents and drafting content related to formulation studies.

Job Requirements:

1. Master’s degree or higher in pharmacy, biology, medicine, chemistry, or a related field;
2. Master’s candidates should have more than 5 years of experience in biopharmaceutical R&D and quality analysis, while PhD holders require at least 3 years of relevant work experience.
3. Led projects in biopharmaceutical quality research/control or formulation development, with at least one product successfully advancing to the clinical trial stage.
4. Possesses strong writing skills and is capable of independently drafting research and experimental plans, protocols, and reports.
5. Preference will be given to candidates with strong English reading and writing skills or those who have studied abroad.