Sr Cellular Therapy Lab Specialist

Job description

JOB SUMMARYThe primary purpose of the Senior Clinical Cellular Therapy Lab Specialist position is to proactively and independently perform complex, highlyspecialized and time-sensitive technical cell manipulation and testing procedures on irreplaceable, life-saving cellular products used fortreatment of cancer patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment. In addition to technical functions, thesenior specialist serves as mentor and resource to Clinical Cellular Therapy Lab Specialists and assists the manager in daily operational duties.EDUCATION
• 2 year / Associate Degree (Required)
• 4 year / Bachelor's Degree (Preferred)
• In lieu of the above education requirements, a combination of experience and education will be considered.LICENSE & CERTIFICATION REQUIREMENTS
• One of the following is required Certifications/Licensures: (Certification as a professional Medical Laboratory Technologist (MT-ASCP
• or MT-AAB, or MT-AMT) or an equivalent in area of specialty., Medical Lab Scientist (MLS) (ASCP))EXPERIENCE
• 5+ years: Experience in clinical cell processing (Required)ESSENTIAL FUNCTIONS (JOB DUTIES)
• Perform cell manipulation/evaluation procedures following standard policies and procedures which include but are not limited to cryopreservation, cell enrichment and/or purging, cell evaluation and sorting, cell culture, cell product thaw/wash and infusion.
• Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, FACT/Netcord, CAP, CLIA.
• Document deviations and events, notify supervisor, technical and quality management personnel in timely manner and assist in investigation of cause and any required corrective actions.
• Maintain technical knowledge of procedures and equipment and be able to initiate and assist Cellular Therapy Specialists in troubleshooting steps.
• Maintain aseptic and/or sterile technique during processing of products to ensure the integrity, viability, and sterility of cellular products until final infusion to the patient. Must adhere to standard cleaning and gowning requirements for the facility.
• Perform error-free calculations, including, but not limited to infusion cell doses, viabilities, dilutions and cell concentrations
• Demonstrate and maintain working and theoretical knowledge of current stem cell transplantation and cellular therapies including but not limited to procurement, processing, testing, storage, and transplantation. Knowledge of various cell sources such as bone marrow, peripheral blood stem cells, and cord blood is essential for understanding the rationale behind methods. Must maintain and apply knowledge regarding donor evaluation, screening and testing, labeling, and product acceptability and release criteria.
• Required to adapt to variable nature of incoming cellular products/samples and participate in the receipt, storage, and transport of products for infusion.
• Follow and adapt to procedures/policies implemented by external companies for commercial cell therapy products. Must adhere to all defined processing and documentation requirements for each product
• Utilize various computer systems and databases to enter, retrieve, and compile data, complete patient laboratory records, and prepare reports for review by laboratory directors, quality assurance, and physicians.
• Coordinate and manage supply inventory required for clinical procedures as well as assigned projects and validations
• Participate in reviewing and evaluating monitoring alarm system reports and promptly notify appropriate manager or designee of excursions. Participate in on-call rotation in the event of an excursion that puts products at risk.
• Participate in a flexible work schedule as needed to accommodate timely preparation of products with highest possible quality.
• Perform quality control testing, equipment routine maintenance, and advanced troubleshooting. Lead in process and quality improvement projects
• Assist in the development of validations of assays/equipment/supplies. Participate in creation of Standard Operating Procedures.
• Perform routine environmental monitoring and equipment maintenance at designated time intervals
• Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care
• Serve as a mentor and train technologists in processing procedures and daily operational processes. Assist in completion of competency assessments and training documentation.
• Individuals may not perform all of these duties, or may perform additional, related duties not listed here.