Cell Management Specialist

Role Summary

The Cell Management Specialist plays a pivotal role in ensuring seamless operations across critical stages of the process. From managing Apheresis Receipt and overseeing Day 0 and Harvest transfers, to coordinating Final Product Packaging and maintaining precise inventory control, this role is central to supporting the core functions that drive success.

Location

Morris Plains, NJ

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 ‚Äúaudit ready‚Äù state
• Provide ‚Äúflow to the work‚Äù 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

Qualifications

• 1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience 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.

Education

• High School diploma required; Bachelor's degree preferred.

Additional Requirements

• Ability to lift up to 50 lbs., assisted.
• Requires handling chemicals such as corrosives, solvents, and bio-hazardous material.