VP, Process Development
- Manage the work of upstream and downstream PD departments, ensure programs progress on time.
- Lead the teams responsible for (antibody or recombinant protein) cell culture, purification and preparation process of small scale and pilot scale development.
- Formulate and organize implementation of process development plan, ensure compliance with Chinese or international regulatory authorities, responsible for writing the IND application materials to CFDA, FDA, TGA, etc..
- Manage the process development departments: create the department management system and project budgets; responsible for staff recruitment, training, incentives and assessment.
- As part of company executives, involvement in the development of the company's strategic planning and decision-making process.
- Biology background, with Ph.D or master's degree, 8 years or more biopharmaceutical industry R & D and management experience.
- Experience in developing CHO or other mammalian cells with monoclonal antibodies or recombinant protein products.
- Familiar with China and the United States drug discovery, regulatory registration and other work processes. Experience with regulatory requirements for registration of biological products, experience leading pre-clinical development projects is preferred.
- Excellence in planning, execution, analysis and problem solving as well as communication and coordination skills.
Please send CV to [email protected]e.com