Summary: The Head of Vein-to-Vein Supply Chain will design, build, and manage an innovative and industry-leading vein-to-vein cell therapy process with Chain of Identity/Chain of Custody for autologous cell therapy. Scope of the role will include apheresis collection network, manufacturing site scheduling, logistics & order management, and master data coordination across multiple clinical centers.
ABOUT ARCELLX: Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a veteran team of biotechnology industry professionals who are developing our ARC-sparX platform that incorporates proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. Arcellx’s vision is to bring ARC-sparX platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices.
- Develop the strategy and business process road map for Arcellx’s vein-to-vein patient services process, incorporating flexibility, reach, and responsiveness for all products in the platform
- Build and lead team to coordinate handling of patients’ apheresis and treatment products across Clinical, Regulatory, and Quality teams, Apheresis/Infusion sites, couriers/logistics companies, Manufacturing, and in the future, Commercialization
- Define “process flow” and business requirements for medical, IT, and future commercial group to manage flow of information about patients, their apheresis products, status of the manufacturing process, product release, and timelines from patient identification through delivery of the drug product for treatment,
- Establish and manage clear accountabilities for ongoing oversight and risk identification and mitigation to ensure a high quality and reliable supply chain.
- Schedule manufacturing of patient production lots and optimize demand and capacity planning
- Select qualify and support Apheresis/Infusion sites and develop strategy for commercial supply network
- Establish management tools to gauge and enhance performance of entire supply chain
Qualifications and Education Requirements
- Bachelor’s degree in a life sciences or engineering discipline, advanced degree preferred.
- Minimum of 15 years of experience in a CMC development, supply chain and/or clinical manufacturing environment.
- Broad knowledge of and experience with cell therapy, including basic technical competence and knowledge of Quality Systems and Regulatory processes; autologous CAR T experience strongly preferred.
- Extensive knowledge of current industry practices, including hands on experience with personalized therapies supply chain systems; experience implementing systems very desirable
- Experience with interpretation and application of guidelines and regulations from health authorities such as FDA
- Proven track record of leadership and accomplishment in fast-paced GMP startup, breakthrough designation product launch or similar drug launch environment very desirable
- Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
- Experience leading cross-functional matrix teams
- Excellent oral and written communication skills. Skilled at presenting complex topics to senior leaders.
- Must have strong organizational skills and an ability to handle track and execute multiple priorities
- Highly motivated, with willingness to acquire new skills and ability to learn quickly
- Strong engineering/scientific understanding, and ability to apply knowledge to process development
- Detail oriented, good documentation practices, technical writing and verbal communication skills
- Possess strong problem solving and analytical skills and be an independent and creative thinker
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Interpersonal and leadership skills to work with teams in different functions and organizations
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.