Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the treatment paradigm for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.
We are seeking a highly motivated and experienced Director/Sr Director, CMC Regulatory Affairs. The Director/Sr. Director, CMC Regulatory Affairs is responsible for
development and lead of the CMC regulatory strategy for our innovative pipeline of early-stage T cell therapies. These capabilities may include but are not limited to develop CMC regulatory strategy, provide internal CMC regulatory guidance and interaction with regulatory agencies. This position is based in Santa Monica, CA and reports to the VP, Clinical Development.
Responsibilities include, but are not limited to:
We offer the opportunity to join a highly dynamic biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.