Cell Management Specialist

Job Title: Cell Management SpecialistLocation: Morris Plains, NJDuration: 09 monthsShift timings: Sunday - Thursday, 06:00 am to 2:30 pm EST

Job Description:

· 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 Client 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 client 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.