Clinical Cell Therapy Lab Specialist

Location:

1620 W Harrison St, Chicago, Illinois 60612

Hospital:
Rush University Medical Center

Department:
Bone Marrow Transplant - Cell Therapy Lab

Work Type:
Full-Time - 40 Hours per week (1.0 FTE)

Work Schedule:

8-Hour Shifts

On-Call Required Once Every 3 Weeks

Pay Range: $29.36 - $47.79 per hour

The Clinical Cell Therapy Lab Specialist is responsible for performing complex, time-sensitive, and highly specialized technical procedures for the processing, evaluation, and preparation of cellular therapy products used in hematopoietic stem cell transplantation, CAR-T therapy, and other advanced cellular treatments. After completing structured training and competency assessment, the Specialist independently performs routine and advanced processing tasks, supports cleanroom operations, maintains accurate documentation, and ensures compliance with regulatory and accreditation requirements.

This role plays a vital part in safeguarding the integrity, sterility, viability, and traceability of irreplaceable, life-saving cellular products.

• Bachelor’s degree in biology, Medical Laboratory Science, Biotechnology, or a related field.
• Certified Medical Technologist, Medical Laboratory Scientist, laboratory discipline specific or specialty certificate (ASCP or AMT);
  If not certified, must obtain certification within 1 year of hire.
• 1–3 years of experience in a clinical laboratory or regulated environment (e.g., blood bank, GMP manufacturing (CFR
  21,parts 210 to 211, cell therapy, stem cell processing)).

• Experience in a Blood Bank, FACT-accredited or FDA-regulated cell therapy laboratory.
• Experience in cleanroom (ISO 7/8) or aseptic processing environments.
• Familiarity with cellular therapy workflows (HPCs, CAR-T, investigational products).

Cellular Processing and Manipulation

• Perform a wide range of cellular therapy procedures in accordance with established SOPs, including:
• Thawing and washing of HPC and CAR-T products
• Cryopreservation and controlled-rate freezing
• Routine cell counts, viability testing, product sampling
• Cell enrichment or depletion techniques (e.g., CD34+ selection)
• Multi-step or multi-day processing workflows (as applicable)
• Maintain strict aseptic technique within CNC, ISO 8, and ISO 7 cleanroom environments, following all gowning, workflow, and contamination-control requirements.
• Perform accurate calculations for dosing, viability, dilution, cell concentration, and recovery metrics.
• Identify irregularities or potential deviations and promptly escalate to senior staff, Lead Specialist, Supervisor, or Quality personnel.

Product Receipt, Verification, Storage, and Release

• Perform chain-of-identity and chain-of-custody verification for all cellular products, including domestic and international arrivals.
• Receive, inspect, document, and evaluate cellular products for compliance with acceptance and labeling requirements.
• Store, monitor, and retrieve products from vapor-phase liquid nitrogen freezers, ensuring full traceability and documentation accuracy.
• Support CAR-T therapy workflows, including receipt, verification, thawing, and product disposition documentation.
• Adjust to variable and time-sensitive schedules driven by patient needs, donor availability, and clinical urgency.

Documentation, Records Management, and Information Systems

• Maintain accurate and compliant documentation according to Good Documentation Practices (GDP), cGMP, cGTP, FACT, and FDA requirements.
• Enter and verify processing, testing, and product data in validated laboratory information systems and databases.
• Prepare and maintain batch records, worksheets, and electronic documentation for supervisory and QA review.
• Support audit preparation and provide documentation for internal and external inspections.

Quality Control, Equipment, and Facility Support

• Perform routine quality control checks and equipment monitoring tasks (daily, weekly, monthly, or as assigned).
• Conduct equipment start-up, calibration checks, temperature monitoring, and basic troubleshooting.
• Assist in responding to equipment alarms or abnormal results and elevate as needed.
• Support cleanroom readiness activities including environmental monitoring support and documentation.
• Help maintain inventory, stock rotation, and qualification of GMP-compliant supplies.

Training, Validation Support, and Process Improvement

• Participate in training programs and competency assessments to achieve and maintain independent status.
• Assist in training new staff, students, or rotating personnel once independent competence is achieved.
• Support validation and qualification activities related to equipment, processes, methods, and technology transfers.
• Provide feedback for SOP revisions, workflow enhancements, and continuous quality improvement initiatives.

Communication and Interdepartmental Coordination

• Communicate effectively with clinical teams, apheresis staff, physicians, triage coordinators, quality personnel, and external collection centers to support timely…