Director of MSAT

CARGO is hiring a Director of MSAT within the Technical Operations Manufacturing Organization to lead Technology Transfer and Comparability activities. This is a key role within the Manufacturing Organization focused initially on technical support of external manufacturing partners for both cell processing and gene delivery platform, and strategic decision making on internal manufacturing operations. Our current network involves up to 7 CDMO partners and 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.

The candidate will work closely with other functions in the Technical Operations team (External Manufacturing, Process Sciences, Gene Delivery and Editing, Quality Control, Quality Assurance, CMC Regulatory, CMC Strategy & Operations) to develop 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, and ensuring continued manufacturing success. This MSAT role is expected to be hands-on in the technical and operational details of the manufacturing process across multiple CDMO partners, with a focus on short term execution on aggressive tech transfer and comparability timelines.

The role is based in San Mateo, CA.

WHAT YOU’LL DO AT CARGO THERAPEUTICS

Key responsibilities of this role will broadly include the following elements:

• Provide technical oversight to ongoing operations at external partners to ensure on-time delivery of project milestones, including execution of formal comparability, tech transfer, and clinical/GMP readiness milestones
• Manage a sub-group within the MSAT team, focused on comparability, tech transfer execution, and technical support for the Clinical team and sites
• Represent MSAT function in both internal and external leadership forums
• Partner within TO on Process Lifecycle Management to ensure alignment of documents to reflect manufacturing process across multiple CDMOs
• Develop internal procedures to manage technology transfer activities, process gap/risk assessments, and comparability activities
• Oversee implementation of process and analytical changes throughout the product life cycle, in partnership with External Manufacturing, Quality Control, Quality Assurance, and other functional groups
• Review capabilities of the CDMOs against CARGO’s product and technology requirements and develop a tech transfer plan
• Lead the Technology Transfer teams for process and analytical method transfers to the CDMO, and in the future, out from the CDMO to potential third-party partners or CARGO
• Support transfer of development candidates from Process Sciences to internal or external facility for GMP manufacturing
• Support the development of PPQ strategy and execution for drug product
• Collaborate within MSAT on manufacturing control strategy for the CARGO product and author appropriate sections of the regulatory documents describing the control strategy
• Review quality and manufacturing procedures at the CDMO and ensure they meet the requirements of CARGO process and control systems
• Provide technical guidance to MSAT team on deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale
• Ensure on time and accurate documentations in support of the various quality records (deviations, CAPAs, change controls)
• Participate in CDMO and supplier audits; identify technical gaps and develop mitigations
• Identify and implement appropriate automation solutions to simplify and evolve the cell therapy manufacturing platform for current and future products
• Participate as a Subject Matter Expert (SME) in health authority interactions, including authoring of regulatory documents
• This role may require travel up to 25-35% of the time to support CDMO and sourcing activities

THE RIGHT STUFF: Required Experience & Qualifications

• BS/MS in Biological Engineering or Life Sciences with 12 years of relevant experience in the biotech industry, or PhD with 8 years experience, with a minimum of 3-5 years of experience in cell therapy modality. The level of the role may be adjusted to Associate Director, based on the totality of candidate experience.
• Experience working with cell therapy processes is required.
• Direct supervisory experience leading small teams is required.
• Tech transfer experience in both early stage (clinical manufacturing) and late stage (commercial enabling) to external partners is required.
• Experience working external CDMO relationships as well as working in internal manufacturing operations is highly desirable.
• Demonstrated evidence of strong project management and timely execution.
• Ability to effectively lead complex projects with a cross-functional internal/external team.
• 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 audiences in oral and written formats.
• Ability to focus on short term delivery, and at the same time, directional focus on the long-term partnership and strategy.
• 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 while we are building the team.
• Ability to hire, develop and retain strong technical talent.

PAY RANGE

The combined pay range for this role is $176,000 - $230,000. 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.