Lead Material Handler, CAR T Warehouse Operations (in Summit, NJ)

About the position

The Lead Material Handler, CAR T Warehouse Operations manages material needs/requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Warehousing Operations Management. The position must adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication and initiation of production deviations and assistance with quality investigations are required, as applicable.

Responsibilities

• Works in a team based, cross-functional environment to complete warehousing tasks required by shift schedule.
• Records material handling / warehouse operations data and information in a clear, concise, format according to proper cGxP requirements.
• Performs inspection and receipt of incoming raw materials and components in coordination with defined specifications and in collaboration with Incoming Quality Control.
• Performs inventory control: cycle counts, material stocking, scrapping.
• Performs kitting operations.
• Completes inventory / material transfer and movement within facility.
• Manages material expiry, lot / batch control, allocation and maintains material condition requirements.
• Quantifies and maintains materials in inventory locations.
• Maintains timing according to the production schedule to ensure on-time material transfers and availability.
• Completes transactions within an electronic warehouse management system.
• Performs inspection and receipt of incoming Apheresis and PBMC and prepares final product shipments for couriers.
• Proactively manages inventory levels within locations to ensure appropriate safety stock / minimum levels are maintained.
• Conducts periodic safety inspections of warehouse areas and equipment.
• Completes training requirements in accordance to defined schedule / curricula.
• Provides on-the-job and classroom training to all departments within the CAR T organization.
• Periodically reviews and provides input on revisions to SOPs related to functional responsibilities.
• Provides support for investigations and issue resolution.
• Assists with resolution of inbound issues (receiving, suspect damages, shipment errors).
• Identifies process and performance improvement opportunities.
• Collaborates with outside departments for warehouse operations including but not limited to Manufacturing, Quality, Materials Management, Process & Technology.
• Performs system testing along with all appropriate documentation of test scripts.
• Provides back up supervisory support.
• Other duties may be assigned, as necessary.

Requirements

• High School diploma/GED or equivalent required and 4-6 years of relevant Warehouse or Manufacturing Operations within an cGxP or regulated environment.
• 2+ years direct supervisor / personal management experience.

Nice-to-haves

• OR Associate/Technical degree and 2-4 years of relevant Warehouse or Manufacturing Operations within an cGxP / regulated environment.
• OR Bachelor's degree and 1-2 years of relevant Warehouse or Manufacturing Operations within an cGxP / regulated environment.
• An equivalent combination of education, experience and training may substitute.