Cellular Therapy Lab Specialis

Community Health Network•Indianapolis, IN

1d•Onsite

About The Position

The primary purpose of the Clinical Cellular Therapy Lab Specialist position is to participate in the performance of highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable, life-saving cellular products used for treatment of cancer patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment.

Requirements

Certification as a professional Medical Laboratory Technologist (MT-ASCP or MT-AAB, or MTAMT) or an equivalent in area of specialty.
Medical Lab Scientist (MLS) (ASCP)
2 year / Associate Degree Chemical or Biological Science, Clinical Laboratory Science, or Medical Technology (Required)
2+ years: Experience as a technician in a clinical laboratory setting (Required)

Nice To Haves

4 year / Bachelor's Degree Chemical or Biological science, Clinical Laboratory Science, or Medical Technology (Preferred)
In lieu of the above education requirements, a combination of experience and education will be considered.
1+ years: Experience in clinical cell processing (Preferred)

Responsibilities

Perform cell manipulation/evaluation procedures following standard policies and procedures which include but are not limited to stem cell and/or cellular product cryopreservation, cell enrichment, 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 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, basic and advanced troubleshooting. Participate in process and quality improvement projects.
Assist in validation of procedures and equipment. Participate in writing 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.