DIRECTOR OF GENE DELIVERY TECHNICAL DEVELOPMENT

Company: CARGO-Therapeutics
Location: San Mateo
Posted on: March 20, 2023

Job Description:

POSITION SUMMARY -
Reporting to the CTO, CARGO Therapeutics is hiring a Director of Gene Delivery Process Development within the Technical Operations business unit. - This is a leadership role and is being recruited to establish long term technical development capabilities to support CARGO's lead asset which is approaching pivotal trial and the rest of the pipeline. - The initial focus of this role will be on lentiviral technology platforms, but over time the team will explore broader gene editing platforms as portfolio evolves. The leader will recruit a team of technical experts and in-house development lab to support the needs of the portfolio. The scope of the role covers the technical development responsibilities for gene delivery and editing in support of CARGO's entire cell therapy portfolio as programs advance from pre-clinical to clinical stages. - The successful candidate will partner closely with Process Science, Manufacturing, Quality, Regulatory CMC and translational research teams to select and design the gene delivery tools and develop process and control system to advance these candidates from research to clinical and eventually translate to commercial manufacturing processes.The role is based in San Mateo, CA. This role may require travel up to 25-35% of the time. -WHAT YOU'LL DO AT CARGO THERAPEUTICS -Key responsibilities of the Director / Sr Director of Gene Delivery Technical Development will broadly include the elements below: - - - - - - Guide the development, characterization and implementation of the gene editing and delivery process (internally as well as in partnership with CDMOs); As such, establish the long-term vision for the Gene Delivery and Editing CMC function - - - - - - Establish a strong technical team responsible for developing manufacturing process for the selected gene delivery platform, which will be focused on lentiviral platform initially - - - - - - Select and develop analytical methods, internally and at contract labs, for the characterization of the vector - - - - - - Develop cost-effective gene delivery commercial manufacturing process suitable for autologous and allogenic cell therapy programs - - - - - - Author, review and approve technical documents that include IND enabling source documents and regulatory submissions - - - - - - Collaborate across all CMC functions including Process Science, and QC, Quality, Manufacturing and CMC Regulatory - - - - - - Develop necessary lab capability in support of commercial process and analytical development of viral vectors - - - - - - Tech transfer viral vector (and other gene delivery platforms in the future) manufacturing process to CDMOs or from CDMO back for internal manufacturing, if needed - - - - - - Provide technical oversight to the gene delivery CDMOs and strategic oversight of the gene delivery topics within the cross functional CMC teams - - - - - - Interface with external consultants supporting CARGO on the gene delivery related strategy topics - -THE RIGHT STUFF: REQUIRED EXPERIENCE & QUALIFICATIONS - - - - - - - Ph.D. or M.S. in Chemical or Biological Engineering, Molecular Biology, Genetics, Virology, or related disciplines - - - - - - 10 plus years of relevant experience, with at least 3 years' experience directly in cell and gene therapy field - - - - - - Minimum 3 years of experience leading scientists/engineers; ideally as a Director - - - - - - Experience developing viral vector manufacturing process, and evolving processes form research to clinical manufacturing and commercialization with broad life cycle management experience. - - - - - - Experience in process and control system development, authoring technical sections of the IND, BLA and other regulatory submissions. - - - - - - Experience tech transferring processes and methods to CDMOs/CMOs and internal manufacturing sites. - - - - - - Demonstrated technical and people leadership, ability to influence without direct authority. - - - - - - Strong problem solving, scientific reasoning skills including practical experience in implementing meaningful technology solutions to simplify cell therapy manufacturing. - - - - - - Ability to effectively communicate complex technical content to a range of audience in oral and written formats. - - - - - - Demonstrated evidence for problem solving, logical scientific reasoning, practical approach to implementing technology solutions to ultimately establish a reliable and robust manufacturing and supply network. - - - - - - Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy. - - - - - - Ability and willingness to roll up the sleeves and be hands-on and flexible while we are building the team. - - - - - - Experience in working with cross functional product teams. - - - - - - Proven record of being able to hire top technical talent. - - - - - - Experience leading small teams comprised of technical experts -PREFERRED EXPERIENCE & QUALIFICATIONS - - - - - - - Experience working with viral vector and cell therapy processes - - - - - - - Experience working external CDMO relationships as well as working in internal manufacturing operation -PAY RANGEThe combined pay range for this role is from $178,608 to $270,972. Title and salary will be based on our assessment of how relevant candidate's skills and experience are to our job requirements. -ABOUT CARGO THERAPEUTICS -CARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generation of best-in-class chimeric antigen receptor (CAR) T-cell therapies. Despite advances made by commercially available autologous CARs, these treatments are curative for fewer than half of all cancer patients. In addition, far too many patients are unable to access these potentially curative therapies due to other challenges, including manufacturing, supply constraints, slow turnaround time and reimbursement hurdles. The team at CARGO is intensely focused on pursuing novel solutions to achieve better cancer treatment outcomes and experiences. ---Our founders are pioneers and world experts in CAR T cell therapy, and we have built a team with experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. CARGO Therapeutics colleagues share a passion to help others thrive.--- We are tenacious in the relentless pursuit of our mission, and we innovate to change the game for the patients we serve. - -Join us to help make a difference! - -EEO & EMPLOYMENT ELIGIBILITY - -CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law. - -CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date.--- This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote.--- If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. -

Keywords: CARGO-Therapeutics, San Mateo , DIRECTOR OF GENE DELIVERY TECHNICAL DEVELOPMENT, Executive , San Mateo, California