POSITION SUMMARY

CARGO is seeking a self-motivated and versatile individual to join us as a Quality Control Scientist within the Quality organization. This is a key role focused on technical support of external manufacturing partners, including supporting method transfer/qualification/validation, technical document authoring, person in plant activities, 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 short term execution on aggressive timelines, method troubleshooting, life cycle management and supporting tech transfer and comparability activities.

The role is based in San Mateo, CA.

WHAT YOU’LL DO AT CARGO THERAPEUTICS

• Support person in plant activities at CDMO(s) as technical method SME.
• Support timely and accurate documentation in support of the various quality records (laboratory investigation, deviations, impact assessments, CAPAs, change controls).
• Support and execute method transfers to the CDMO and in the future out from the CDMO to potential third-party partners or CARGO.
• Provide hands-on technical support to laboratory investigation, deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale.
• Provide hands-on technical oversight to ongoing operations at external partners to ensure on-time delivery of project milestones and batch disposition.
• Translate analytical technical requirements into executable and compliant manufacturing and quality documents for lead asset and future pipeline products.
• Review capabilities of the CDMOs against CARGO’s product and technology requirements and help to develop a tech transfer plan.
• 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 reviews data and assists with product and assay control trending and monitoring.
• Perform additional duties as assigned.

THE RIGHT STUFF: Required Experience & Qualifications

• PhD or MS degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely related field, and +2 years of industry experience, preferably in gene and cell therapy.
• Experience with relevant technologies on multi-color flow cytometry, MSD, Immunospot, cell culture (e.g. aseptic techniques, cell line expansion), multiplexed immunoassay, NGS, qPCR, ddPCR methods, endotoxin, sterility testing (e.g.. Rapid Milliflex, BacT/alert).
• Experience with method transfer/qualification/validation, routine testing in QC environment.
• Knowledge related to laboratory information management system (LIMS) and electronic lab notebook record keeping (ELN).
• 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.
• Proficient in MS Word, Excel, Project, and PowerPoint.
• 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.
• Proficient with Microsoft Office products and Teams.

PAY RANGE*

The combined pay range for this role is $108,000 - $145,000. *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 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 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.