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. 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. 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. #J-18808-Ljbffr Delan Associates, Inc