Director/Sr Director, CMC Regulatory Affairs

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:

• Interpret global regulations and guidance to identify risks and provide strategic guidance to cross functional product teams.
• Develop CMC regulatory strategy for early-stage cell therapy products through late stage and product registration.
• Represent CMC regulatory affairs on product teams and in health authority interactions.
• Lead development and compilation of Quality modules for global regulatory submissions including but not limited to clinical trial applications, health authority responses and briefing packages.
• Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity and accuracy.
• Lead the build out CMC regulatory organization to support expanding cell therapy pipeline.
• Serve as a strong partner to the Development and TechOps organizations.
• Perform other duties as required.

• Hire, lead, managing workflow and develop of staff.

Requirements:

• Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, handle and prioritize multiple projects and work independently.
• Excellent communication and collaboration skills to work in a fast paced start up environment.
• Highly developed leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
• Ability to deal with time demands, incomplete information or unexpected events
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.

• BA/BS degree in life sciences required Advanced degree preferred (PhD, MS, PharmD).
• 8 to 10 years’ experience in CMC Regulatory Affairs.
• Prior experience in cell therapy preferred.
• In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
• Experience leading CMC teams in IND, IMPD, BLA, MAA filings.

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.