Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a CAR-T Manufacturing Logistics Specialist as part of the Technical Development team based in Somerset, NJ.
Role Overview
The CAR-T Manufacturing Logistics Specialist supports the Patient Journey from start through completion. This is a key role within the organization focused on end-to-end CAR-T cell logistics, chain of custody and chain of identity, and management of third-party supply chain vendors. We seek a highly motivated individual who can manage all aspects of scheduling logistics. This associate will support the execution of clinical trials in both establishing processes and procedures, and logistical execution. Key to this role will be supporting logistics of patient and raw material movement and understanding and managing the criticality of Chain of Custody (CoC) and Chain of Identity (CoI) for the drug product. Coordination of scheduling, management of clinical trial material arrival and departure, and communication of issues are main roles and responsibilities.
Key Responsibilities
- Manage the coordination, shipping, receiving, transfer, and logistics of raw materials, samples, product, and supplies across Legend’s network of sites, including GMP Storage vendors, Contract and Development Manufacturing Organizations, and Clinical Sites.
- Serve as direct liaison for the ordering, transportation, delivery, and problem resolution for patient material, supporting the manufacturing schedule.
- Develop and manage scheduling plans for manufacturing, apheresis receipts, and DP (Drug Product) shipments.
- Liaise with and resolve shipping issues with logistics couriers related to delays or technical challenges in a timely fashion to ensure delivery of clinical trial material on time.
- Investigate/resolve any shipment excursions in collaboration with Quality Assurance.
- Manage the development, implementation, continuous improvement, and enforcement of logistics and CoI-related SOPs for all aspects of Technical Development.
- Assist with Clinical Site onboarding and Qualification activities, as needed.
- Track key logistics metrics and identify areas of improvements.
- Establish new processes and procedures as identified within current V2V processes.
- Support development, build, testing, and roll-out of new capabilities as we build out automated processes and bring processes in-house.
- Establish key stakeholder relationships with partner functions such as Clinical Operations, CMC, quality, regulatory, and manufacturing.
- Functioning in a matrixed environment, drive key activities and timelines, holding stakeholders accountable to the program objectives.
Requirements
- BS or MS Degree in Engineering, Supply Chain or equivalent discipline is required or related discipline. Advanced technical training and experience preferred.
- Minimum of 2 years’ experience in CAR-T Supply Chain Operations. Customer facing experience is required. Experience within a launch / start up environment is preferred.
- Experience with GMP, cell therapy logistics, particularly Chain of Custody/Chain of Identity systems (paper-based and E-Systems), is highly desirable.
- Experience with temperature-controlled shipments, logistics, and E-Systems is highly desirable.
- Development of collaboration, influencing, and negotiation skills to work effectively with internal cross- functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
- Knowledge of global clinical studies, from Phase 1 to Late Phase.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Ability to communicate clearly and effectively with all levels of the organization.
- Understanding of escalation processes and requirements.
- Good written and verbal skills.
- Ability to work hands on, independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
