Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)
Greater San Francisco area - This is an on-site role and candidates will need to relocate.
Associate Director, Cell Culture Process Development (Retained Role)
The Associate Director, Cell Culture PD is responsible for and leads all aspects of cell culture development for the gene therapy platform focused on AAV. This role is responsible for leading cell culture development activities starting from Research, progressing through tox and clinical studies, and ultimately defining the process needed for initial IND, Phase 3, and commercial launch.
Process development is also responsible for the manufacture of research grade gene therapy materials for characterization and animal testing.
This individual will also oversee a small team as well.
- Minimum of a BS degree but PhD is preferred
- Minimum 8 years' of experience within biotech or pharma
- Proven experience in developing cell culture processes
- Familiar with FDA, ISO, EMA, GMP and ICH requirements
- Direct experience with gene-based and rAAV-based therapies will be a plus
- Experience with late-stage development and process characterization/validation in support of product licensure is highly desired
- Experience managing and coaching staff is highly desired
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.