Cell Management Specialist

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