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, Analytical Development (Retained Role)
The Associate Director will develop analytical methods to support the development of the company's genomic therapies, including genome editing, gene regulation, gene therapy and cell therapy. This individual will lead the assay development and will be responsible for designing and implementing biological and molecular biology related methods.
The Associate Director will also be responsible for being an analytical development representative on product specific CMC teams and coordinate all analytical development activities. As part of this responsibility, the Associate Director will also take lead authorship and or review/editing roles for module 3 analytical section for drug substance and product in support of regulatory filings.
This individual will also oversee a team of about 6-8 people.
- PhD in a relevant, scientific area
- 10+ years of experience (must have some industry background) with a focus on bioassay method development for biologics products
- Hands-on experience with cell-based bioassays and method development
- Knowledge of FDA cGMP requirements is a must
- Combination of both NGS and CMC experience
- AAV-mediated gene therapy, gene editing and cell therapy experience is highly desired
- T-cell, iPSC and immune oncology method development experience is plus
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.