Principal Engineer, Vector MSAT - San Carlos, United States - Cargo Therapeutics

Description

CARGO Therapeutics is hiring a Vector MSAT Principal Engineer within the Technical Operations business unit. This role reports to the Director of Vector MSAT and is being recruited to establish long term technical development capabilities to support CARGO's lead asset, which is currently in pivotal trial, and support the rest of the pipeline. The initial focus of this role will be on lentiviral technology platforms, but over time the team will explore broader gene editing platforms as the portfolio evolves. The scope of the role covers the technical support of vector and gene editing manufacturing processes from pivotal to commercial stages, supporting both internal and external vector programs. This role will be focused on transfer of vector candidates to external manufacturing sites for optimization, technical oversight of the CMOs (Contract Manufacturing Operations) producing vectors for late stage, and vector life cycle management including process improvements. The successful candidate will partner closely with the Process Sciences, Gene Delivery, External Manufacturing, Quality, CMC Regulatory, Supply Chain, R&D, and Translational Medicine teams to optimize gene delivery tools, develop process and control systems, and ensure robustness and consistency of vector manufacturing process for stable vector supply as assets move from clinical to commercial stages. The role is based in San Carlos, CA. This role may require travel up to 25-35% of the time. WHAT YOU'LL DO AT CARGO THERAPEUTICS Key responsibilities of the Vector MSAT Principal Engineer will broadly include the these elements:

• Provide technical support of vector CDMOs for deviation management, lot disposition, and batch record reviews to ensure that technical issues stay off the critical path for reliable vector supply
• Lead the development of commercial readiness documentation including process characterization protocols/reports, process control strategies, process qualification, and comparability strategies across vector programs
• Provide technical input for early-stage programs
• Lead vector PPQ planning and execution as a technical SME
• Author technical sections of regulatory documents to contribute to the overall CMC strategies for current vector and future gene editing technologies
• Lead tech transfer activities for viral vector programs, if needed
• Contribute to CDMO selection for future vector programs as a technical SME
• Provide technical input and drive long-term process improvements
• Contribute as a critical team member to the cross-functional CMC team to advance CARGO programs

THE RIGHT STUFF: Required Experience & Qualifications

• Minimum of 12 years of related experience with a Bachelor's degree, 8 years and a Master's degree, or a PhD with 5 years experience, or equivalent experience, with at least 3 years of experience directly in the cell and gene therapy field; degree in Chemical or Biological Engineering, Molecular Biology, Genetics, Virology, or related disciplines
• Experience with viral vector manufacturing process in process development or MSAT role, with experience evolving processes from clinical to commercialization
• Experience with long-term lifecycle management for clinical and commercial products
• Experience working with external CDMOs
• Experience in process and control system development, authoring technical sections of the IND, BLA, and other regulatory submissions
• Experience tech transferring processes to CDMOs/CMOs
• Demonstrated technical expertise; ability to influence without direct authority
• Strong problem solving, scientific reasoning skills including practical experience in implementing meaningful technology solutions in manufacturing setting
• Ability to effectively communicate complex technical content to a range of audiences in oral and written formats
• Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy
• Ability and willingness to roll up the sleeves and be hands-on and flexible
• Experience in working with cross functional product teams

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- 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.