Cell Management Specialist

Delan Associates•Morris Plains, NJ

23h•Onsite

About The Position

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.

Requirements

1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience preferred.
High School diploma required
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

Nice To Haves

Bachelor's degree preferred.

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
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