Cell Management Specialist

Delan Associates, Inc

Cell Management Specialist

Morris Plains, NJ
Full Time
Paid
  • Responsibilities

    **Title: 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
    **

    Job Description Summary
    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.

    Job Description
    Key Responsibilities:
    o Follow all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time performance
    o Ensure prompt and precise data entry
    o Maintain compliance with training requirements
    o Keep Manufacturing Support areas in an “audit ready” state
    o Provide “flow to the work” support when needed/available
    o Perform equipment cleaning and maintenance in accordance with governing SOP requirements
    o Escalate and help reconcile any observed compliance or safety issues
    o Be proficient in various operating systems, such as LIMS, SAP, and MES
    o Support monthly and annual cycle counts
    o Participate in site/team projects and initiatives
    o Act according to Novartis Values and Behaviors
    o Ensure accurate SAP/MES inventories for all components
    o Properly segregate and store all conditioned materials
    **
    APH Receipt / Final Pack / Day 0 / Harvest Activities:**
    o Receive and inspect incoming leukapheresis
    o Package and ship final products
    o Deliver scheduled Day 0 apheresis for patient processing on time
    o The Harvest and storage of final product
    o Receive and store final products from scheduled patient processing
    o Resolve outstanding issues with internal and external customers through follow-up communication
    o Coordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exports
    o Verify inventory accuracy of GMP and non-GMP LN2 storage locations
    o Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activities

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