Principal Engineer, Cell Therapy Process Development - San Carlos, United States - Cargo Therapeutics

Description

Reporting into the Senior Director of Process Development, CARGO is hiring a Cell Therapy Process Development Principal Engineer within the Process Sciences organization in Technical Operations. The candidate will contribute to and support development of GMP-compatible manufacturing processes for production of CARGO's cell therapy products. The ideal candidate will have a background in cell selection, lentiviral transduction, cell culture and expansion, and flow cytometry analysis. The successful candidate will work closely with the Process Sciences team and the broader CMC team to advance PD-related CMC deliverables for our pivotal drug candidate. The individual will also collaborate cross-functionally to ensure timely development, manufacture, and release of drug products, as well as support regulatory submissions.

The role is based in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

• Provide technical oversight to ensure timely completion of Process Development related CMC deliverables such as risk assessments, plan documents, process characterization, material specifications, filter qualifications, extractables testing, packaging and labeling qualification, and container closure testing
• Guide scientists and engineers through these late-stage deliverables to drive exposure and career development
• Work with cross-functional teams to drive internal alignment on overall requirements (technical, quality, regulatory) and timeline to achieve these deliverables
• Where required, partner with contract testing labs to define requirements, author, and review protocols, provide testing materials, execute testing, and document results per defined timelines
• Participate in the development and characterization of cell therapy manufacturing processes
• Support technology transfer to partners at external contract manufacturing organizations, including compilation of documentation (reports, SOPs, batch records, assessments)
• Participate in laboratory set-up and equipment procurement, and establish internal process development practices
• Author relevant documentation (protocols, technical reports, SOPs)
• Organize, communicate, and present data to key stakeholders, senior management, and external partners

THE RIGHT STUFF: Required Experience & Qualifications

• 6+ years of postdoctoral experience with PhD, 8+ years with MS, or 12+ years with BS in applicable scientific or engineering disciplines such as biotechnology, bioprocess, molecular biology, immunology, or biochemistry
• 4+ years of experience in supporting late stage/pivotal cell therapy assets as process development Subject Matter Expert
• Strong problem-solving skills for developing creative, innovative solutions, and meeting project objectives are required
• Highly organized and capable of leading multiple projects independently
• Must have interpersonal, organizational, written, and verbal communication skills, and the ability to work collaboratively in a team environment
• Proficiency in Office, JMP, Benchling, and other productivity and data analysis tools
• Experience with cell therapy CMC filing strategy, quality and regulatory guidelines, regulatory audit support, manufacturing operations, and lifecycle considerations
• Some travel to contract testing labs may be required

PAY RANGE

The combined pay range for this role is $136,000 - $187,000. 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-

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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.