Material Handler, CAR-T Warehouse Operations

Role Summary

The 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. Material Handlers must adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Responsibilities

• Performs inventory control: cycle counts, material stocking, scrapping, at a minimum.
• Manages material expiry, allocation, kitting, and maintains material condition requirements.
• Quantifies and maintains materials in production dispensary.
• Perform apheresis receipt of incoming raw materials and prepares final product shipments for couriers.
• Maintains timing according to the production schedule to ensure on-time logistics.
• Records material handling data and information in a clear, concise format according to proper GDPs.
• Works in a team based, cross-functional environment to complete warehousing tasks required by shift schedule.
• Must be able to work in an environment with blood derived components.
• Other duties may be assigned as necessary.
• Performs other tasks as assigned.
• Available to work OT if / when business requires.
• Flexible to work across both Summit and Warren NJ sites if needed.

Knowledge & Skills

• Knowledge of cGMP/FDA regulated industry
• Basic mathematical skills
• General understanding of cGMPs
• Technical writing capability
• Proficient in MS Office applications
• Inventory control and/or management
• Background to include an understanding of biology, chemistry, medical or clinical practices is a plus

Basic Requirements

• Bachelor's degree and no prior experience.
• OR Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience within a cGMP environment.
• OR High School diploma/GED and 4 years of Manufacturing or Operations experience within a cGMP environment.
• Strong computer skills.
• Strong attention to detail required.
• Ability to work in a fast-paced environment with multiple competing priorities.
• Ability to gown appropriately in a cGMP environment.
• Willing to work staggered shift hours.

Working Conditions

• Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Ability to lift from 25-50 pounds.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.