Director, Product Quality Management

CARGO Therapeutics is hiring a Director of Product Quality Management within the Quality Organization in Technical Operations. The role will initially report to the Head of Quality Operations & Systems and may have a different reporting arrangement as the Quality organization evolves. The individual will serve as the Quality Expert for assigned CARGO Cell Therapy programs (Vector and Drug Product) and is responsible for 1) establishing an overall quality roadmap for the lead asset leading up to the eventual product approval as well as early stage quality plan for pipeline assets 2) executing to this plan, working cross functionally with other functions in Technical Operations 3) developing product and process control strategy, including specifications, collaborating with Analytical Development, QC and Regulatory groups 4) supporting ongoing Quality Operations team to provide product specific expertise. The candidate will have previous experience leading and managing product quality for cell therapy programs in a phase-appropriate manner and will provide a proactive front-end approach to product quality.

The role can be Remote or located at Headquarters in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

• Develop product quality strategies and quality lifecycle plan for lead asset (Vector and Drug Product) and execute to this plan; serve as the single point of decision for product specific quality related decision that requires cross functional input

• Actively monitor product metrics and signals (e.g. cpk/stability, etc.) and initiate/support improvement projects to enhance performance and/or mitigate quality risks across the development portfolio

• Working with QC, Analytical Development and CMC Regulatory, provide technical expertise and quality input into review and approval for overall product analytical strategy, method development, method transfer, qualification, and validation

• Work in close partnership with Process Sciences to develop a product quality profile as input to the overall target product profile

• Lead investigation in response to quality signals/complaint trends or critical deviations, working with SMEs across Technical Operations

• Support and enable strategic management of Quality Risk Management for assigned CARGO products

• Participate in and support complex investigations, Material Review Boards, Change Management, Specification Committee, and critical quality complaint resolution activities

• Serve as Quality approver of key strategic product documents (e.g. specifications, stability plans, process descriptions, QbD documents, and Process Development plans)

• Ensure holistic quality reviews are performed and standards established for regulatory filings, inspections, and external audits as required

• Act as the lead Quality input to ensure the product teams are fully aligned around the Quality Strategy

• Own the APR/PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion

• Interface with Regulatory Affairs to author, review and approve filings and represent Quality in product related agency meetings and regulatory inspections as required

• Author and own policies/procedures to ensure product quality requirements are defined and implemented for CARGO

THE RIGHT STUFF: Required Experience & Qualifications

• Bachelor's degree in Virology, Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology

• Minimum 12-15 years' pharmaceutical experience; preferred experience in cell therapy or biologics product development and licensure

• Demonstrated expert knowledge of relevant global regulations and guidance

• Experience in cell line development, production, and qualification of attenuated viral banks

• Experience developing process/product control strategy including specifications

• Experience authoring regulatory submission documents and responding to health authority review questions

• Knowledge of product licensure submissions and process required; ATMP submission experience highly preferred.

• Ability to think strategically and influence others

• Excellent verbal and written communication skills; strong interpersonal skills

• Strong scientific and global cGMP compliance expertise to ensure robust analysis of complex data to recommend and/or make risk-based Quality decisions in biopharmaceutical product life cycle management

• Collaborate cross-functionally; develop strong relationships with partners both internally and externally

• Confident, independent self-starter; proactive and results-oriented with high performance standards

• Exhibit highest integrity and is committed to ethics and compliance standards

• Strong ability to prioritize and operate with a sense of urgency

• Flexibility to travel as required to accommodate business needs

PAY RANGE

The combined pay range for this role is $172,000 - $235,000. 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/.

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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.