Senior Manager, Quality Control

CARGO is seeking a self-motivated and versatile individual to join us as a Senior Manager, QC within the Quality organization. This is a key role focused on method qualification/validation, method life-cycle management, technical support of external manufacturing partners, including supporting method transfer, technical document authoring, person-in-plant activities, impact assessment, laboratory investigation, and method trending/monitoring. The candidate will work closely with Analytical Development, Process Development, Quality Assurance, Translational Science, Biometrics, and Regulatory team members. This role is critical in developing a strong partnership with our CDMOs in pursuit of advancing our pipeline and is expected to be hands-on in the technical and operational details of the Manufacturing and Quality Control operation at CDMOs, with focus on method validation, method troubleshooting, life cycle management, and supporting tech transfer and comparability activities.

This is an on-site role based in San Carlos, CA (with the possibility for Remote work from an East Coast-based location).

WHAT YOU’LL DO AT CARGO THERAPEUTICS

• Contribute to and implement method qualification and validation strategy. Accountable and responsible for implementing the detailed method qualification and validation strategy with the CMOs and CTLs.

• Review and approve method qualification/validation protocols and reports; may need to author method qualification/validation protocols and reports.
• Support person-in-plant activities at CDMO(s) as a technical method SME.
• Support timely and accurate documentation in support of the various Quality records (laboratory investigation, deviations, impact assessments, CAPAs, change controls).
• Provide hands-on technical support to laboratory investigation, deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale.
• Review executed test methods at the CDMO and ensure they meet the requirements of CARGO process and regulatory guidelines.
• Collaborate closely with Analytical Development to support, execute and/or provide oversight in the execution of method optimization, extended characterization, troubleshooting, transfer, and qualification/validation.
• Develop, revise, review, approve, and own SOPs (Standard Operating Procedures) and technical (transfer, validation, bridging, etc.) protocols/reports.
• Assist in reviewing data and assist with product and assay control trending and monitoring.

• Perform additional duties as assigned.

THE RIGHT STUFF: Required Experience & Qualifications

• Bachelor’s or Master’s degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely related field, and 7+ years of industry experience, preferably in gene and cell therapy.
• Experience with relevant technologies on multi-color flow cytometry, Immunospot, cell culture (e.g. aseptic techniques, cell line expansion), multiplexed immunoassay, qPCR, ddPCR methods, endotoxin, sterility testing (e.g.. Rapid Milliflex, BacT/alert).
• Experience and successful track record of method transfer/verification/qualification/validation, routine testing in QC environment.
• Knowledge related to scientific data analysis applications such as GraphPad Prism, FlowJo, FACSDiva, Novocyte, Spotfire, and JMP software packages.
• Excellent technical writing experience in a regulatory environment (such as protocols, reports, and SOPs).
• Results-oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements "best practices" or leading-edge quality standards.
• Project Management skills, including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
• Experience in IND, NDA and BLA submission is highly preferred.
• Availability to work extended hours to meet deadlines when necessary.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Highly effective written and oral communication skills to address a wide variety of audiences and governing bodies.
• Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving skills in a variety of situations.

• Travel - Domestic and International, up to 25-35%, to support CDMO activities.

PAY RANGE

The combined pay range for this role is $145,000 - $200,000. 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.