Cell Management Specialist

Cell Management Specialist

Location: Morris Plains, NJ Shift timings: Tuesday - Saturday, 10 AM : 6:30 PM EST & Sunday to Thursday, 10 AM : 6:30 PM EST

The Cell Management Specialist is tasked with Apheresis Receipt, Final Product Packaging, Day 0 and Harvest transfers, Inventory Management, and other duties essential to support core functions.

Key Responsibilities:

• Follow all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time performance
• Ensure prompt and precise data entry
• Maintain compliance with training requirements
• Keep Manufacturing Support areas in an "audit ready" state
• Provide "flow to the work" support when needed/available
• Perform equipment cleaning and maintenance in accordance with governing SOP requirements
• Escalate and help reconcile any observed compliance or safety issues
• Be proficient in various operating systems, such as LIMS, SAP, and MES
• Support monthly and annual cycle counts
• Participate in site/team projects and initiatives
• Act according to Novartis Values and Behaviors
• Ensure accurate SAP/MES inventories for all components
• Properly segregate and store all conditioned materials

APH Receipt / Final Pack / Day 0 / Harvest Activities:

• Receive and inspect incoming leukapheresis
• Package and ship final products
• Deliver scheduled Day 0 apheresis for patient processing on time
• The Harvest and storage of final product
• Receive and store final products from scheduled patient processing
• Resolve outstanding issues with internal and external customers through follow-up communication
• Coordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exports
• Verify inventory accuracy of GMP and non-GMP LN2 storage locations
• Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activities

Role Requirements:

• 1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience preferred.
• High School diploma required; Bachelor's degree preferred.
• Strong interpersonal, written, and communication skills, along with problem-solving and follow-up abilities.
• Must be well organized, flexible, and able to work with minimal supervision.
• Ability to lift up to 50 lbs., assisted.
• Requires handling chemicals such as corrosives, solvents, and bio-hazardous material