Cell Management Specialist

Delan Associates, Inc; Morris Plains (NJ); On-site; USD 45,000 - 60,000; Full time

Job summary

Delan Associates, Inc is seeking a Cell Management Specialist based in Morris Plains, NJ. This role involves managing apheresis receipt, final product packaging, and inventory management. Candidates should have 1-3 years of related experience in a cGMP environment, strong communication skills, and the ability to work independently.

Responsibilities include ensuring compliance with SOPs, maintaining accurate data and inventory, and participating in team initiatives. A high school diploma is required, with a bachelor's degree preferred.

Qualifications

• 1-3 years of related experience in a cGMP/FDA regulated industry required.
• Warehouse experience preferred.
• Must be able to lift up to 50 lbs., assisted.
• Experience handling corrosives, solvents, and bio-hazardous material.

Responsibilities

• Follow SOPs and maintain compliance with training requirements.
• Perform equipment cleaning and maintenance.
• Ensure accurate data entry and inventory management.
• Participate in site/team projects and initiatives.

Skills

Communication skills

Problem-solving abilities

Organizational skills

Flexibility

Education

High School diploma

Bachelor's degree

Tools

LIMS

SAP

MES

Job description

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.