General Summary

• This is a position in the Cell Therapy Laboratory in the NCI designated Marlene and Stewart Greenebaum Comprehensive Cancer Center at the University of Maryland Medical Center (MSGCCC at UMMC). This unique lab supports lifesaving treatments for cancer patient in the Transplant and Cellular Therapy Program. We are seeking a highly motivated, Cell Therapy Specialist to join our Cell Therapy Team.

• The Cell Therapy Specialist performs and/or verifies all tasks associated with manufacturing, processing, manipulation, and cryopreservation of Hematopoietic Progenitor Cells (HPC) and other related cellular products, distribution and shipment of HPC and other related products to the University of Maryland Medical Center (UMMC) clinical areas and other outside facilities. Ensures activities are performed in accordance with accepted standards and practices, as well as, regulations stipulated by the Foundation for the Accreditation of Cellular Therapy, United States Food and Drug Administration, and other agencies as required by the activity. Provide support of clinical research trials that require management investigational products (IP) including formulation of IP for administration to patient.

• Serves as a technical resource to clinical staff in the specialized area of cell therapy including cryopreservation of HPC and other related products. Responsible under the direction of lab leadership for ordering and acquisition of supplies and equipment, personnel training and competencies for a small laboratory unit.

Principal Responsibilities and Tasks

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.

Complies with established departmental standards and practices/procedures; follows strict principles of asepsis and antisepsis; uses standard techniques.

• Cleans and disinfects all equipment and apparatus used in the performance of tests prior to and after use, as appropriate.
•  Troubleshoots problems with equipment and corrects, as appropriate.

Develops and implements procedures in the UMCC Cell Therapy Lab, to assure the efficient and effective operation of the unit and to reflect current FDA, Foundation for the Accreditation of Cellular Therapy and American Association of Blood Banks (AABB) standards and other regulating or accrediting agencies as appropriate.

Develops, documents, performs and teaches cryopreservation of mononuclear cells, bone marrow and peripheral blood stem cells in accordance with governing standards and departmental procedures.

• Responsible for ongoing training of physicians, technologists or technicians by teaching and demonstrating methods, techniques and operation of equipment as well as monitoring their work in various training assignments.
• Serves as technical resource person for blood cell cryopreservation, providing guidance and direction to technologists on matters such as technical procedures, equipment, instrumentation requirements, and equipment calibration.
• Participates in research, development and implementation of processes or improved laboratory procedures and techniques. Makes recommendations to improve or augment the efficiency and effectiveness of cryopreservation services.
• Ensures equipment and instruments are properly calibrated and in sound operating condition; advises on equipment condition; advises on equipment modification or replacement. Develops and implements quality control program. Tests and evaluates equipment operation and various control levels with specimens, such as temperatures and environmental conditions being within acceptable limits. Documents test results.

Prepares, completes, and maintains records and reports to document technical, quality control, budgetary, personnel or supply activities of unit.

• Maintains inventory of disposable supplies needed to perform apheresis, ordering from Central Supply, or specific vendors, as needed.
• Maintains acceptable drug inventory for cell therapy procedures. Documents inventory amounts and orders replacements from the Pharmacy as needed.

Performs data collection, computer data storage, maintenance and data analysis. Records statistics from the lab work. Enters patient information or disposition of blood for therapeutic, research or apheresis products into the department computer system as needed.

• Assists in the maintenance of departmental records by preparing and filing patient procedure information as necessary. Maintains patient/donor cell therapy files.
• Generates patient service charges for procedures performed.
•  Communicates with medical and nursing staff that are requesting laboratory tests, as needed, to clarify the specifics surrounding particular test requests, to ultimately assure that the proper test is performed on the specimen.

Ensures equipment and instruments are properly maintained and successfully troubleshoots processing and equipment issues while communicating said issues to management.

Complies with established lab standard of practice (SOP) and procedures. Participates in the evaluation and revision of SOPs that are technically sound, provides clear instructions to align with cGXP requirements and supports efficient operations.

Finds opportunities for improvement in cell therapy efficiencies and compliance while assisting with investigations/deviations, audits, and change controls.

Renowned as the academic flagship of the University of Maryland Medical System, our Magnet®-designated facility is a nationally recognized, academic medical center with opportunities across the continuum of care. Come join UMMC and discover the atmosphere where talents and ideas come together to enhance patient care and advance the science of nursing. Located in downtown Baltimore near the Inner Harbor and Camden Yards, you won’t find a more vibrant place to work! 

Education and Experience

• Bachelor’s degree in Medical Laboratory Technology, Biology, Microbiology, or Chemistry is required.
•  Certification as a registered Medical Technologist obtained from the American Society of Clinical Pathologists, or eligibility to obtain, or equivalent certification, is preferreded.
• CPR certification is required.
• Experience with either commercial or clinical manufacturing is preferred.

Knowledge, Skills and Abilities

• Knowledge of the principles of Medical Technology, biology, chemistry or microbiology, hematology and clinical laboratory process, testing and analytical procedures, and the principles of the particular area of specialty, where applicable, is required.
• A high level of analytical ability is required to resolve difficult and complex technical problems encountered, e.g. stem cells being tested for content, prepared for cryopreservation and frozen, and maintained in liquid nitrogen storage is required.
•  Ability to read, write, speak English and perform mathematical and statistical operations for recording and evaluating lab results, including, addition, subtraction, multiplication, division and algebraic functions is required. Ability to follow detailed written or verbal instructions accurately is required.
• Ability to operate laboratory equipment, such as, a centrifuge, chemistry analyzers, fluorescent microscope or specialized laboratory equipment specific to the assigned laboratory. Ability to use a computerized system for logging and tracking laboratory test results and patient information, and for calibrating laboratory equipment is required.
• Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served on the assigned unit. The individual must demonstrate knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient’s requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures.
• Effective verbal and written communication skills are necessary in order to work with medical or nursing staff, resolve problems and concerns regarding specimens or lab tests and to properly record test results and quality control statistics. Effective interpersonal and written communication skills are necessary to assign work to, and conduct an on-going training of physicians, technologists or technicians.

Patient Safety

Ensures patient safety in the performance of job functions and through participation in hospital, department or unit patient safety initiatives

• Takes action to correct observed risks to patient safety.
•  Reports adverse events and near misses to appropriate management authority.
• Identifies possible risks in processes, procedures, devices and communicates the same to those in charge.

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