Website Kanghong Pharmaceutical
General Manager, R&D of Biosimilar
1、Lead biosimilar candidate screening and development. Organize project evaluation, program planning，execution, and process management.
2、Set up and manage external collaborations. Coordinate with external partners or CROs to accelerate the development programs.
3、Organize project review and evaluation during various development phases, report development status and progress to the senior management team on a regular basis, and manage regulatory filings related activities.
4、Resolve challenges during product research and development, and contribute to preparation of new biologics patents.
5、Provide technical support to the Institute of New Drug Research or Marketing groups.
6、Complete ad-hoc tasks assigned by the upper management.
1、Ph.D. degree in Molecular Biology or pharmacy-related majors.
2、Familiarity with China’s biologics drug registration regulations and application process.
3、Knowledge of technical requirements of biosimilar drug development, familiarity with the cutting-edge technologies in biopharmaceutical research and development, and able to grasp the industry development trends.
4、Managerial experience in presiding over the research and development of at least 2 biosimilar drugs, familiarity with biologics drug research and development process, including pre-clinical research, process development and product specification development, possess good project management skills and coordination skills.
5、Working experience in completing CMC sections for at least 2 investigational new drug projects and passed on-site inspections by regulatory agencies.
6、Good English communication skills.
7、More than 2 years of team management experience in R&D at overseas enterprises; 5+ years of working experience in biologics R&D; Familiarity with R&D in monoclonal antibody drugs is preferred.