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Senior Director, CMC Launch Lead - San Carlos, CA, United States - CARGO Therapeutics
Description
Reporting to the Head of CMC Strategy & Operations, CARGO Therapeutics is seeking a Senior Director, CMC Launch Lead within Technical Operations. This individual will lead a cross-functional CMC team focused on launch readiness of CARGO's lead autologous cell therapy asset CRG-022. Key responsibilities include establishing a detailed timeline and roadmap for all launch enabling technical operations activities, overseeing the execution of these cross-functional activities, contributing as a cell therapy CMC technical expert towards BLA preparation, site launch, supply readiness, and a lifecycle management plan. The incumbent will have previous experience leading and managing cross-functional teams, preferably having worked on BLA enabling stages of cell therapy product.
The role is based in San Carlos, CA but may also be suitable for a West Coast Remote arrangement.
WHAT YOU'LL DO AT CARGO THERAPEUTICS
Establish and lead a technical operations focused launch readiness team for CARGO's lead autologous cell therapy asset (CRG-022), ensuring strong stakeholder engagement across the broader CARGO organization
Develop the CMC launch strategy and plan for CRG-022
Serve as the primary Technical Operations representative in all cross-functional launch focused forums
Champion and implement a tracking and visualization tool that provides an industry leading capability to leverage manufacturing and supply metrics (e.g. TAT, OOS, etc.) in the development of BLA and launch strategies
Build an assessment matrix that enables the development of a lifecycle management plan that provides clarity and visibility into the prioritization and timing of post approval changes that can be understood by and communicated to stakeholders across the broader CARGO organization
Work in close partnership with Commercialization on the development, qualification, and implementation of a digital portal
Stay abreast of the cell therapy CMC external landscape and ensure our strategy remains agile and competitive
THE RIGHT STUFF: Required Experience & Qualifications
Degree (graduate or undergraduate) in Chemical or Biological Engineering of Life Science or relevant field
Minimum 12-15 years' pharmaceutical experience; preferred experience in cell therapy or biologics product development and licensure
Minimum 2 years of cross-functional team leadership experience
Demonstrated success as a direct contributor or leader in the launch of at least 1 biotechnology product
Experience in product development (e.g. development of process/product control strategy, authoring regulatory submission documents, responding to health authority review questions, etc.)
Knowledge of product licensure submissions and process required; ATMP submission experience highly preferred
Ability to think strategically and influence others
Excellent verbal and written communication skills; good interpersonal skills
Collaborate cross-functionally, and develop strong relationships with partners both internally and externally
Confident, independent, self-starter; proactive and results-oriented with high performance standards
Exhibit highest integrity and committed to ethics and compliance standards
Strong ability to prioritize and operate with a sense of urgency
Flexibility to travel as required to accommodate business needs
PAY RANGE
The combined pay range for this role is $215,000 - $295,000. 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 .
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.
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