Under general supervision, operates the Marlene and Stewart Greenebaum Cancer Center (MSGCC) Cell Therapy Laboratory or Fannie Angelos Cellular Therapy (FACT) Laboratory to include the manufacturing, processing, manipulation, and cryopreservation of 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 sponsor-initiated clinical research trials that require management of trial-related documents and investigational products (IP) including formulation of IP for administration to patient.
Serves as principal 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.
II. 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.
Performs, documents, and teaches cell manufacturing, collection, processing, cryopreservation, and thawing and infusion of HPC and other related cellular products in accordance with governing standards and departmental policies and procedures.
Responsible for training and competency evaluations of new employees. Provides guidance and direction to new employees in all aspects of their job description
Serves as technical resource for clinical staff when applicable
Complies with established departmental standards, practices, and procedures, follows strict principles of asepsis and antisepsis, uses standard techniques, maintains and troubleshoots problems with equipment and corrects problems, as appropriate Assists the Facility Director and Medical Director with the formulation of policies, procedures and protocols relating to laboratory operations and maintenance, instrument and equipment validation and maintenance, and manufacturing processes. Recommends changes in laboratory procedures where appropriate, to assure the efficient and effective operation of the lab and to reflect current Fact, FDA, State, and Joint Commission Standards and other regulating or accrediting agencies.
Recommends the addition or modification of laboratory equipment, as necessary.
Ensures compliance with requirements of accreditation and regulatory agencies through periodic inspections, audits and observation of practices. Participates in the Quality Management System by reporting and investigating occurrences and planned deviations, and implementing corrective actions/process improvements under the direction of quality.
Assists in the evaluation of process performance and recommends, initiates and effects measures to improve services and quality of cell therapy. Assists in the design and development of new services.
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 the cell therapy services.
Ensures equipment and instruments are properly maintained, 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, and supply activities of unit.
Maintains adequate inventory of supplies needed to perform procedures, ordering from Central Supply, Pharmacy, or specific vendors as needed.
Performs and maintains data collection, computer data storage, data analysis, and statistics. Maintains complete department records for the collection and/or disposition of all blood and components collected and processed by the Cell Therapy Laboratory.
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, and processes charges.
Communicates with medical and nursing staff that are requesting procedures, as needed, to clarify the specifics surrounding particular requests.
Assists in new research treatment protocols as directed by and under the direct supervision of the Principal Investigator.
Company Description THE MEDICAL HEART OF MARYLAND
Treating over 330,000 patients every year, the University of Maryland Medical Center is at the vital core of Maryland's health care system and community. We're known for our prestigious expertise in innovative research and education, along with the talented staff and advanced centers that make it all possible. The R Adams Cowley Shock Trauma Center, the world's first center dedicated to trauma, treats more than 7,500 critically injured patients a year with an incredible 97 percent survival rate. We also have one of the nation's largest kidney and pancreas transplant programs at The Joseph and Corinne Schwartz Division of Transplantation, home to Maryland's first steroid-free protocol and pancreas/kidney transplant. From our National Cancer Institute-designated UM Marlene and Stewart Greenebaum Cancer Center to The University of Maryland's Children's Hospital, one of the largest pediatric centers in the state, we are dedicated to saving and transforming lives.
Qualifications
Education and Experience
Bachelor's degree in Medical Laboratory Technology, Biology, Microbiology, or Chemistry, Biomedical Engineering or equivalent combination of education.
Certification as a registered Medical Technologist from the American Society of Clinical Pathologists, or equivalent preferred.
CPR certification is required.
Two (2) years' experience, three years preferred, performing Medical Technologist duties required, one (1) of which involved working with blood bank policies and procedures is highly desired. In addition, laboratory skills in the handling of blood products, and or biopharmaceutical based GMP cryopreservation, is also desired.
Experience in in cell culture, cryopreservation and aseptic processing techniques is required.
Experience with both commercial and clinical manufacturing is preferred.
IV. 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.
Proficiency in use of computerized systems for tracking and evaluating manufacturing milestones, laboratory and equipment maintenance schedules and inventory control.
A high level of analytical ability is required to resolve difficult and complex technical problems encountered, e.g. The collection and analysis of Hematopoietic Progenitor Cells, preparation for cryopreservation, handling Liquid Nitrogen, and the transplantation of cells.
Ability to perform mathematical and statistical operations for recording and evaluating lab results, including, addition, subtraction, multiplication, division and algebraic functions. Ability to follow detailed written or verbal instructions accurately. Ability to maintain aseptic manufacturing procedure including proper cleanroom gowning protocol and maintenance of the cleanroom environment.
Strong writing, and technical editing skills.
Ability to operate laboratory equipment, such as, a centrifuge, microscope, cell processors, and other specialized laboratory equipment specific to the assigned duties. Ability to use a computerized system for logging and tracking laboratory test results and patient information.
Ability to demonstrate knowledge and skills necessary to provide assistance and care appropriate to the age of the patient and/or family being treated on the 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 requests, and to properly record results and quality control statistics. Effective interpersonal and written communication skills are necessary to assign work to, and conduct training of new employees, and orientation of physicians and nursing staff.
Ability to handle potentially infectious materials, such as, blood and body fluid specimens observing proper safety regulations and procedures.
V. Safety
Ensures patient safety in the performance of job functions and through participation in hospital, or unit based patient and employee 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
Additional Information All your information will be kept confidential according to EEO guidelines.
