Scope of responsibilities:

1. Able to professionally define, plan and execute the key contents and milestone events involved in CMC, and sufficiently support the company's established project objectives;

2. Able to carry out coordination and management work of internal inter-departmental as well as external cooperation units，such as early development, process development, analytical methods, QC/QA, RA, CRO and CDMO, etc., ensuring the consistency of project objectives, proposed plans and actual work;

3. Able to independently carry out the specific work in the progress of the project and write the corresponding work reports to achieve real-time tracking of the project, ensuring that the project is actively move forward;

4. Able to maintain good communication with key project stakeholders and senior management on a continuous and timely basis on the strategies, status and decisions involved in CMC.

Requirements:

1. Master's degree or above, majors in molecular biology, cell biology, immunology, biochemistry, bioengineering and other related fields;

2. 3 years or more work experience of development or production of new drugs in biopharmaceutical or pharmaceutical companies , with some expertise in the corresponding fields such as antibody development, protein purification, protein analysis, structural characterization and quality control. Professional project management training or experience is preferred;

3. CMC work experience in preclinical and/or clinical development, preferably in different clinical phases of Phase I/II/III;

4. Good communication and collaboration skills, abilities in oral and written expression, team leadership and professional judgment;

5. Good written and oral English skills.