Cell Management Specialist
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. This role requires adherence to all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time performance. The specialist will ensure prompt and precise data entry, maintain compliance with training requirements, and keep Manufacturing Support areas in an “audit ready” state. They will provide “flow to the work” support when needed, perform equipment cleaning and maintenance, and escalate/reconcile compliance or safety issues. Proficiency in various operating systems like LIMS, SAP, and MES is expected. The role also involves supporting monthly and annual cycle counts, participating in site/team projects, and acting according to Novartis Values and Behaviors. Accurate SAP/MES inventories for all components and proper segregation/storage of conditioned materials are crucial. Specific activities include receiving and inspecting incoming leukapheresis, packaging and shipping final products, delivering scheduled Day 0 apheresis, harvesting and storing final product, receiving and storing final products from patient processing, resolving outstanding issues, coordinating shipping/receiving/storage/processing of goods (including imports/exports), verifying inventory accuracy of GMP and non-GMP LN2 storage locations, and ensuring availability/accuracy of materials and documentation.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
