We are seeking a highly motivated and enthusiastic individual to join us as a CMC, Associate Director, in our R&D Therapeutics team. You will work with the research team in the exciting areas, including antibody generation and engineering, cancer immunotherapy, autoimmune disorders and other diseases. This role will be a hands-on resource reporting to the Director.
- Oversees and directs all chemistry, manufacturing and controls (CMC) regulatory and manufacturing strategies for new and mature products
- Provides guidance and support to internal groups such as marketing, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations
- Provides strategic input and risk assessments and oversees preparation of CMC regulatory submissions
- Interacts with regulatory agencies
- Selects, develops and evaluates personnel to ensure the efficient operation of the function