Senior Scientist, Analytical Development (Potency)

Reporting to a lead within the Process Sciences team, CARGO Therapeutics is seeking a highly motivated and versatile individual to join us as a Senior Scientist in Analytical Development within the Process Sciences organization. In this position you will contribute to the development of cell-based assays, including potency and functional assays, as well as molecular assays for both lot release and characterization of CARGO's CAR T-cell therapy products. You will contribute to novel assay development, fit-for-purpose method qualification, troubleshooting of assay/equipment related issues, SOP/authoring/review, document management, data analysis and execution of routine analytical testing. The candidate will work closely with the Analytical Development and Process Development teams as well as with the broader CMC team. The candidate will collaborate cross-functionally to ensure timely development, manufacture, and release of drug products as well as support regulatory submissions.

This is an on-site role based in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

• Plan, coordinate and execute analytical testing to assess T-cell function, such as cell-based potency assays (ELISA, ELISpot, Ella)

• Plan, coordinate and execute analytical testing of molecular assays such as qPCR/ddPCR and flow cytometry-based assays

• Design and execute characterization studies using both cell-based assays and high-throughput molecular and cellular techniques to interrogate immune cell biology and function

• Support routine Process Development testing as well as other internal/external studies

• Successfully execute and document laboratory procedures and experiments with great attention to detail

• Perform technical root-cause investigations for aberrant results and deviations relating to analytical methods

• Collaborate closely with Analytical Development and Quality Control groups to support, execute and/or provide oversight in the execution of method optimization, method qualification, characterization, troubleshooting, transfer, and validation

• Support method transfer to partners at external contract manufacturing organizations, including compilation of documentation (protocols, test methods, reports)

• Develop, revise, review, approve, and own SOPs (Standard Operating Procedures) and technical (transfer, validation, bridging, etc.) protocols/reports

• Create and manage project plans, define project deliverables, lead and facilitate working teams

• Organize, communicate and present data to key stakeholders, senior management and external partners

• Analyze data, assist in the preparation of reports and data packages

• Monitor and conduct process trending

• Perform additional duties as assigned

THE RIGHT STUFF: Required Experience & Qualifications

• Demonstrated experience in cell therapy, immunology, cancer biology, molecular biology or a closely related field; BS with 8+ years of industry experience, MS with 6+ years, or PhD with 4+ years

• Experience with relevant technologies with an emphasis on potency and functional assays, cell culture (e.g. aseptic techniques, cell line expansion), flow cytometry-based assays and ddPCR

• Experience with routine testing in GLP and/or GMP 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, SnapGene, Novocyte, Spotfire, and JMP software packages

• Proficient in MS Word, Excel, Project and PowerPoint

• Experience with gene and cell therapies or pharmaceutical industry

• 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

• Available to work extended hours to meet deadlines when necessary

• 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

PAY RANGE

The combined pay range for this role is $114,000 - $156,000. 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.