- Lead or support internal or external technology transfer activities
- Act as MSAT technical SME/POC for manufacturing execution escalations
- Perform person-in-plant activities at CDMO(s) as technical SME
- Author technical documents including batch records, SOPs, risk assessments, impact assessments, protocols, and reports
- Lead or support phase appropriate comparability studies
- Support development and authoring of process control strategy and lifecycle management
- Translate process and 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 quality and manufacturing procedures at the CDMO and ensure they meet the requirements of CARGO process and control systems
- Participate in CDMO and supplier audits, identify technical gaps and develop mitigations
- Develop a clear set of technical material requirements
- Support other BLA-enabling deliverables in collaboration with internal and external partners
- Provide hands-on technical oversight to ongoing operations at external partners to ensure on-time delivery of project milestones and batch disposition
- Support timely and accurate documentation in support of the various quality records (deviations, impact assessments, CAPAs, change controls)
- Provide hands-on technical support to deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale
- Oversee implementation of process changes throughout the product life cycle
- Travel - domestic (mainly Northeast) and international, up to 25% to support CDMO activities
- Undergraduate/Graduate degree in Biology, Biological Engineering or other life sciences with 8+ years of relevant experience in the biotech industry, with a minimum of 2-3 years of experience in cell therapy modality
- Tech transfer experience in both early stage (clinical manufacturing) and late stage (commercial enabling) to external partners is highly desirable
- Experience working with cell therapy processes is highly desirable
- Experience working external CDMO relationships as well as working in internal manufacturing operation is highly desirable
- Experience with data analysis using programs such as JMP or Minitab
- Demonstrated evidence of strong project management and timely execution
- Ability to work cross-functionally with internal/external team to meet deadlines
- Ability to troubleshoot complex manufacturing investigations combining technical, compliance and business considerations working with cross functional teams
- Strong technical foundation in biologics or cell/gene therapy manufacturing process and technology
- Ability to effectively communicate complex technical content to a range of audience 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
- Ability to hire, develop and retain strong technical talent
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Senior Engineer, MSAT - San Carlos, United States - Cargo Therapeutics
Description
CARGO is hiring a Senior Engineer, MSAT within the Technical Operations Manufacturing organization. This is a key role within the CARGO Manufacturing Organization focused on leading technology transfers for cell therapy processes, including supporting person-in-plant activities, technical document authoring, data analysis, and contributing to functional team projects. Our current network involves multiple CDMO partners and it is expected to grow as we build out the end-to-end supply chain for our cell therapy portfolio, with the lead asset already in the clinical stage of development. Work at the CDMO includes oversight and potential optimization of the manufacturing process, tech transfer in to the CDMOs (and potentially back to CARGO or another CDMO in the future) in preparation for a registration enabling clinical trial for the lead asset, and commercial readiness.
The candidate will work closely with other functions on the Technical Operations team (External Manufacturing, Process Sciences, Vector MSAT, Quality Assurance, Quality Control, CMC Operations, and CMC Regulatory) to support development of the internal and external manufacturing strategy and execute against the strategy to ensure reliable deliverables throughout the project life cycle. This role is critical in developing a strong partnership with our CDMOs in pursuit of advancing our pipeline. This MSAT role is expected to be hands-on in the technical and operational details of the manufacturing process, with focus on short term execution on aggressive timelines, tech transfer, manufacturing execution, identifying failure modes and mitigation plans, supporting processing monitoring and data analytics activities, and commercial readiness/PPQ activities.
The role is based in San Carlos, CA.
WHAT YOU'LL DO AT CARGO THERAPEUTICS
Key responsibilities of the Senior Engineer, MSAT will broadly include:
The combined pay range for this role is $112,000 - $154,000. 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.
