Warehouse Operations Shift Lead

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 Warehouse Operations Shift Lead as part of the Technical Operations team based in Raritan. 

Role Overview

The CAR-T Warehouse Operations Lead will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Professional expertise with good understanding of Warehouse and Logistics and able to resolve a wide range of issues. Contributes to the development of concepts and techniques. Completes complex tasks in creative and effective ways.

Key Responsibilities  

This individual will serve as a subject matter expert for warehouse operations and performed daily warehouse operation processes, including inbound, outbound, storage, and replenishment. This individual will also work with and assist inventory management systems and execute cycle count and reconciliation activities to ensure inventory accuracy. This individual will also support the optimization and efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions about packaging, methods, storage, and inventory for internal and external stakeholders. This individual will work closely with freight forwarders, receiving parties, and internal clients. This individual will need to train and follow standard operating procedures and work instructions and comply with cGMP regulations and safety guidelines. Work with supervisor to schedule daily operations that includes people, product, and material flow across multiple shifts. This individual will assist the Warehouse Supervisor with Quality Investigations, Change Controls, Document Revisions, and ongoing Process Improvements.

• Establish key stakeholder relationships with internal and external stakeholders.
• Ability to interact with all levels within the organization.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
• Job duties include operating industrial power vehicle  Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
• Using Audiometric Devices: No average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1000Hz and 2000Hz with or without a hearing aid. 

Requirements

• Minimum of high school diploma and/or equivalent combination of education and work experience is required.
• A minimum of 2 years of experience within warehouse operations and logistics within a cGMP manufacturing environment in the biotech/biopharma industry is required. A minimum of 2 years of experience in Quality Investigations, Change Controls, Document Revisions, and Process Improvements.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Knowledge of cGMP regulations and FDA guidelines. 
• Experience using material handling equipment, SAP, or similar inventory management system is required. Cold supply chain knowledge and fork lift truck license is preferred.
• Ability to lift a minimum of 50 lbs and stand for a long period of time.
• Physical dexterity sufficient to use computers and documentation.
• Ability to accommodate shift work including evenings and weekends as required by operational needs.
• Ability to accommodate unplanned overtime on little to no