Responsibilities

• Establish process development and scale-up manufacturing function for cell therapy including establish a CMC manufacturing process for cell therapy
• Manufacture and testing the cells
• Provide subject matter expertise for the organization from early preclinical to clinical manufacturing to eventual commercial production; identifies key issues and critical activities throughout project/product lifecycles
• Responsible for all CMC matters related to pre-IND meeting and IND filing such as process definition, understanding and control, analytical tests particularly potency assays and comparability studies
• Institute a donor supply and screening program to support a reliable supply of suitable GMP donors. Ensure our pool of donors will meet the FDA standards to manufacture allogeneic cell products