Associate Director, CMC Regulatory

San Carlos, CA, United States

Description

Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio.

The successful candidate will have a strong background in regulatory CMC with deep expertise in biologic product development. They must have comprehensive knowledge of regulatory requirements and expectations in major regions (US, EU) and will be responsible for the development of sound CMC regulatory strategies. The Associate Director will work closely with colleagues in Clinical Regulatory, Quality, Technical Operations, and Translational Medicine both as a leader and as an individual contributor for the development of effective product development strategies. They will lead the planning, content and creation of regulatory submissions such IND, CTA/IMPD, MAA, BLA, and health authority meetings. This individual will also help to develop the infrastructure, processes and procedures needed for a rapidly growing function.

The role is on site in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

Represent Regulatory CMC on cross-functional teams to help progress CARGO's cell-based gene therapy pipeline

Proactively identify and communicate risks and propose solutions to complex regulatory CMC issues

Develop comprehensive CMC regulatory filing strategies that anticipate and meet the requirements and expectations of global health authorities for cell-based gene therapies

Guide and lead teams in seeking scientific advice from health authorities on CMC development aspects

Interpret global regulations and guidance to identify regulatory opportunities and risks to CARGO's cell-based gene therapy portfolio

Evaluate technical change proposals and develop effective implementation strategies as appropriate

Lead technical teams in the development of CMC submissions (IND/IMPD, MAA/BLA) for global markets ensuring compliance, quality, coherence, and timeliness, including creation and maintenance of strategy documents

Support departmental initiatives, including special projects, budgeting, and authoring departmental documents such as operating procedures, manuals and guides

Collaborate effectively with technical SMEs to evaluate technical and health authority requirements and prepare CMC sections of the regulatory dossiers

THE RIGHT STUFF: Required Experience & Qualifications Minimum of Bachelor's degree in a scientific or engineering discipline

10+ years of experience working directly in regulatory CMC or in a relevant technical development discipline, such as process development, analytical development, or quality assurance, including at least 6 years' experience directly in CMC regulatory

Advanced knowledge of FDA, EMA and ICH guidelines and regulatory requirements

Experience in developing biologic drugs is essential, with a strong preference for experience leading CMC regulatory strategy for cell-based gene therapies

Prior experience with the preparation of biologic marketing applications through the review and approval process in major markets is advantageous

Ability to understand technical aspects of the manufacture, characterization and control of biologic therapies and describe them in regulatory submissions

Strong planning and organizational skills with a history of prioritizing and multitasking multiple projects in a fast-paced environment utilizing excellent time management skills

Adept at working autonomously, as well as collaboratively in a dynamic team environment

PAY RANGE

The pay range for this role is $140,000 - $193,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

ABOUT CARGO THERAPEUTICS

CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.

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 required 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.