Position Summary
We are hiring for the role of Director of Analytical Development (AD) within the Process Sciences team (Technical Operations) at Cargo. The focus of the role is to ensure phase-appropriate development/qualification and readiness of analytical methods for release, characterization and stability keeping in mind the line of sight towards commercialization. While the initial focus will be on the lead autologous CAR T asset, the role is expected to evolve the entire pipeline with multiple programs currently in the pre-clinical stages. Later stage analytical development and life cycle management experience is highly desired. The role is within the Process Sciences organization of technical operations and will report to the VP of Process Sciences.

What You’ll Do at Cargo Therapeutics
Key responsibilities of the Director of Analytical Development (AD) are summarized below, and these will likely evolve over time as the portfolio matures.

• Direct technical and laboratory activities focused on method development, qualification, and analytical strategy for CAR-T gene therapy products
• Advance scientific understanding of CAR-T products by directing studies aimed at deepening product understanding
• Establish collaborative working relationships between analytical development, research, and quality control departments both internally and at external CDMOs.
• Develop scientifically sound and phase appropriate methods to release and characterize CAR-T products
• Provide scientific and technical guidance for flow cytometry, cell-based potency, and molecular based assays
• Support transfer analytical methods to CDMOs and ensure the methods are GMP ready for the phase of development and scientifically sound.
• Oversee analytical development services provided by CDMO partners
• Lead all aspects of method development and work with QC for transfer, characterization, validation, investigations required
• Support product development to ensure timely and robust data analysis, establishment of control strategy, and incorporation within Tech Ops functions
• Provide analytical development input to IND and other regulatory filings, including developing justification of specification
• Collaborate with internal SMEs and CDMOs to automate methods and improve method performance
• Benchmark external practices and evolving regulatory landscape for cell and gene therapy to continually improve methods specifically with respect to method performance and method cycle time
• Develop release and characterization methods for incoming raw materials, as needed

THE RIGHT STUFF: Required Experience & Qualifications

• Undergraduate/Graduate degree in life sciences or Chemical/Biological engineering with 10 plus years of experience in the biotech industry. The level of the position will depend of the candidate experience and level of education.
• 3-5 years of relevant experience in cell and gene therapy is highly desirable. Direct or indirect supervisory experience leading small teams is preferred. Later stage experience in analytical development and life cycle management is highly values for this role.
• Analytical method qualification and transfer experience in both early stage (clinical manufacturing) and late stage (commercial enabling) to external partners is required.
• Experience working external CTL relationships as well as working in internal manufacturing operation is highly desirable
• Demonstrated evidence of on-time execution
• Ability to effectively lead complex projects with a cross-functional internal/external team.
• Technical expertise in flow cytometry, molecular biology and/or cell-based potency methods
• Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management
• Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.
• Ability to troubleshoot complex method investigations combining technical, compliance and business considerations working with a 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.
• Ability to focus on short term delivery and at the same time directional focus on the long-term goals
• Knowledge of 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.

PAY RANGE

The combined pay range for this role is $188,410 - $259,063. 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.