Job Abstract

The Cell Therapy Lab Specialist, under moderate supervision, performs technical processing procedures, associated quality functions, and lab maintenance related to autologous and allogeneic hematopoietic progenitor cells (HPC) and therapeutic cellular therapy products within the Seidman Cancer Center Hematopoietic Malignancy and Cellular Therapy Program.

With moderate supervision, performs a variety of duties related to the processing of cellular therapy products according to standard operating procedures. Processes stem cells from initial evaluation to finished product status in an accurate and timely manner using aseptic techniques. Prepares cellular products for infusion under appropriate regulatory and quality guidelines. Interfaces regularly with nurses, coordinators and physicians to prepare cell products for patient treatment according to physician’s orders. Assists clinical staff during the infusion of cellular therapy products. Prepares appropriate documentation for processing and infusion records. Achieves and maintains competency in common lab procedures including aseptic technique, cryopreservation/thawing, cell selection, centrifugation, and washing. Demonstrates proficiency with lab equipment required for the processing of human products. Assists in interpretation of test results, including: automated and manual cell counts, viability, flow cytometry, infectious disease marker panels, and sterility testing. Performs patient dose calculations during processing to assess product yields. Labels cell products while maintaining chain of custody and identity in collaboration with the clinical and product transport teams. Works as part of a team to correlate data based on results, technical expertise, and other conditions affecting test results or process outcomes. Assists in the validation and development of new procedures to optimize processes. Enters and maintains records of procedures and data, both manually and on electronic data capture systems. Reviews records for acceptability, accuracy, and completeness. Documents procedures according to Good Documentation Practice guidelines. Ensures equipment, reagents and supplies are properly utilized and performs reagent and instrument quality control at the appropriate intervals, interpreting and recording results. Ensures equipment undergoes preventative maintenance and calibration on a regular schedule. Utilizes reagents and supplies in accordance with manufacturer guidelines and/or standard operating procedures. Reviews critical reagents and supply receipts, storage, and applicable manufacturer certificate of analysis or conformity prior to use. Ensures effective collection and shipment/receipt of cell products with appropriate documentation. Performs supply procurement and billing of executed procedures. Maintains a well-organized, stocked, and clean work area. Monitors inventory levels ensuring adequate supplies. Tends to cell product storage in liquid nitrogen 24/7 to ensure products are not compromised by thaw prior to infusion. Demonstrates and maintains knowledge of quality, safety, and compliance programs while maintaining records to meet standards/requirements of the hospital and licensing/accrediting agencies including, but not limited to, FDA, FACT, CAP, and CLIA. Adheres to departmental guidelines, safety/regulatory requirements, and applicable regulatory and quality standards. Provides a safe environment for patients. Reports safety concerns, errors, and near misses related to cellular products for administration. Participates in the Lab Quality Management Program designed to ensure patient safety by process control and prevention of errors.

Associate's Degree in biotechnology or medical lab science and 3 years’ experience in a clinical, analytical or biotech/Pharma lab Required or Bachelor's Degree in biological science, medical laboratory science or related field and 1 year experience in a clinical, analytical or biotech/Pharma lab.

Experience in aseptic technique, quality and regulatory compliance Required and Experience working in a regulatory environment Required

Familiarity with laboratory equipment Required
Knowledge of FDA, cGMP, and cGTP Required
Exhibits excellent organizational, planning, and time management skills Required
Good judgement, critical thinking skills, and problem solving abilities Required
Excellent written, verbal, and interpersonal communication skills Required
Extreme attention to detail Required
Capable of working in a fast-paced and rapidly changing environment and technology Required
Working knowledge of Microsoft Word, Excel, and PowerPoint

Medical Lab Technician (MLTASCP) or Medical Technologist (MT-ASCP) preferred or required to obtain upon Hire