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 an Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, NJ.
Role Overview
The Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations team responsible for building operations activity area readiness activities/processes, aiming to support start of a personalized clinical cell therapy site meeting cGMP requirements. This individual will serve as the point of contact for daily distribution of process materials, subject matter expert for operations inventory management and point of contact for oversight of operations transactions during processing, including material consumption overview, RFT documented goods movement for batch, accurate and cGMP storage of materials within activity areas, replenishment of materials in activity area, scrapping, outbound delivery orders, and ERP troubleshooting. In addition, will develop performance monitoring indicators, maintain data integrity of inventory records, and will assist with utilization and improvements of Legend's ERP system.
Key Responsibilities
- Distributes process materials (raw materials, kits, etc) to the process teams.
- Tracks issuance of additional materials for inventory accuracy.
- Supports inventory management systems and execute cycle count and reconciliation activities to ensure inventory accuracy.
- Supports the optimization and efficient utilization of the operations space.
- Assists in regulatory inspections, perform safety and quality audits, and answer relevant questions about storage, material consumption, material allocation, and inventory for internal and external stakeholders
- Continuous and/or Active monitor of ERP and EBR systems during processing hours to ensure GMP standards of ALCOA+ system transactions within operations activity areas.
- Leads and works closely with operations, warehouse, supply chain, materials planning, and internal client teams.
- This individual will need to develop, train and follow standard operating procedures and work instructions and comply with cGMP regulations and safety guidelines.
- Ensures integrity of inventory systems and data records through monitoring and reconciliation of inventory related transactions over multiple material flow channels: consumptions, reversals, scrapping, outbound, inventory differences, material movements and usage.
- Develops departmental area analysis, performance, and metrics packages to showcase strategic analyses to support business and corporate objectives.
- Contributes initiatives and projects to promote and enhance current processes, policies, and capabilities to higher levels regarding inventory control within operations activity areas.
- Develops and provides guidance and training on policies and procedures, both initial and continuous, to internal and external parties responsible for receiving, storing, distributing, transacting inventory, and system usage.
Requirements
- Preferred: Associates degree or Higher. Minimum: A minimum of a High School Diploma is required.
- A minimum of 2 years of experience within manufacturing and/or warehouse operations and logistics within a cGMP manufacturing environment in the biotech/biopharma industry
- Previous and proven experience in an inventory control, supply chain and logistics environment.
- Experience with SAP S4 Hana or similar ERP system.
- Experience in cycle counting and physical inventory administration.
- 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 prior notice.
- Perform other job-related duties as assigned · Must be able to work in a team environment.
- Experience working with Microsoft Office Professional (Excel, Word & PowerPoint) .
- Ability to promote a mindset of continuous improvement, problem solving, and prevention.
- This is an on-site position. Candidate must be willing to work on site full time.
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.
