Cell Therapy Lab Scientist- Cellular Therapy Laboratory

Overview

The Cell Therapy Lab Scientist performs cellular product processing, utilizing various separation and processing techniques. This role is responsible for conducting both qualitative and quantitative testing on cell therapy products while maintaining strict aseptic technique throughout all procedures involving cellular materials. The technologist ensures accurate and timely documentation of each process step in accordance with established standard operating procedures (SOPs) and institutional policies. The position requires full compliance with all applicable regulations and standards, including cGMP, cGTP, FACT, CAP, and AABB.

Responsibilities

• Performs cellular product processing using established methods such as Ficoll separation and cryopreservation, adhering to aseptic techniques and safety protocols at all times
• Labels, stores, and manages cellular products in accordance with institutional procedures and regulatory standards to ensure proper tracking, identification, and storage conditions
• Maintains accurate and timely documentation for all processing, testing, labeling, storage, and deviation events in compliance with quality assurance protocols and regulatory requirements
• Executes all responsibilities with a high degree of precision, consistency, and within established timeframes, supporting the timely delivery of safe therapeutic products
• Develops and demonstrates an understanding of the clinical application of cellular products, including how processing outcomes directly impact patient therapy and care
• Monitors for process deviations or unexpected outcomes, promptly identifying and reporting issues to supervisory personnel and following escalation procedures as needed
• Learns and applies regulatory compliance standards related to the manufacturing and testing of cell therapy products, including cGMP, cGTP, FACT, AABB, and CAP

Qualifications

Bachelor's Degree in Medical Technology, Medical Laboratory Science, Clinical Laboratory Scientist, Chemistry, Biology, Immunology, or Molecular Biology. Experience in a clinical or research laboratory, particularly in cellular therapy, hematology, immunology, or related field.

Skills and Abilities

• Complies with the Cell Therapies Facility's standard operating procedures and policies related to processing, analytical testing, reporting, and documentation of cellular product manufacturing for clinical or research purposes
• Ability to follow and interpret SOPs, QC, and QA metrics
• Strong communication, teamwork, and analytical skills
• Able to recognize issues that could negatively impact product quality, test accuracy, or result reporting, and must take corrective action according to standard procedures or notify supervisory personnel immediately