CAR-T Manufacturing Logistics Specialist

1 week ago

Trenton, United States CareerBuilder Full time

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. Thisis a key role within the organization focused on end-to-end CAR-T cell logistics, chain of custody and chain ofidentity, and management of third-party supply chain vendors. We seek a highly motivated individual who canmanage all aspects of scheduling logistics. This associate will support the execution of clinical trials in bothestablishing processes and procedures, and logistical execution. Key to this role will be supporting logistics ofpatient 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 trialmaterial 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 Legends network of sites, including GMP Storage vendors, Contractand Development Manufacturing Organizations, and Clinical Sites.

Serve as direct liaison for the ordering, transportation, delivery, and problem resolution for patientmaterial, 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 technicalchallenges 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 logisticsand 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 automatedprocesses 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 tothe program objectives.

Requirements

BS or MS Degree in Engineering, Supply Chain or equivalentdiscipline is required or related discipline. Advanced technicaltraining 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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