Clinical Cell Therapy Specialist II

The primary purpose of the Clinical Cell Therapy Specialist position proactively and independently performs complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable, lifesaving cellular products used for treatment of cancer patients undergoing Cellular Therapy treatment. In addition to technical functions, the specialist serves as mentor and resource to Cell Therapy Associates and assists supervisor in daily operational duties.

KEY FUNCTIONS

Cell Manipulation and Processing: 
* Perform cell manipulation/evaluation procedures following standard policies and procedures which include but not limited to cryopreservation, cell enrichment and/or purging, cell evaluation and sorting, cell culture, cell product thaw/wash and infusion. Complete responsibility and awareness is required while performing procedures, which may take from few hours to over 36 hours before completion. Certain procedures may require several days of processing over an extended time such as 2-6 weeks. To ensure ownership and accountability of critical steps, procedure/product is assigned to one (maximum of two for certain procedures) Cell Therapy Specialist(s) and/or Technician(s) who is responsible for the entire process on scheduled days required per protocol until product is infused into the patient.
* Maintain technical knowledge of procedures and equipment and be able to initiate and assist Cell Therapy Associates and/or Technicians in troubleshooting steps.
* Perform error free calculations, which include but not limited to infusion cell doses, viabilities, dilutions and cell concentrations. Must be able to explain/train Cell Therapy Associates and/or Technicians on these calculations.
* Responsible for aseptic handling of products at all steps to ensure the integrity, viability and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility and may be required to work in clean room environment requiring specialized gowning such as masks/goggles, sterile jumpsuits, hair and shoe covers.
* 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.
* Demonstrate and maintain extensive working and theoretical knowledge of current adoptive T cell therapies, including but not limited to tissue procurement, processing, testing, T cell expansion, cryopreservation, storage and infusion. Knowledge of T-cell therapy is essential for understanding the rationale behind methods. Must maintain and apply knowledge regarding culture and evaluation of cellular products including labeling, screening, testing, understanding product acceptability and release criteria. Must be able to assist in education of Cell Therapy Associates and/or Technicians in this area.
 

Product monitoring, receiving, storage and retrieval:
* Must be able to follow and adapt to procedures/policies implemented by various clinical trials that may differ from standard operating procedures of MDACC Cell Therapy Laboratory. Must adhere to all defined processing and documentation requirements for the clinical trial.
* Be flexible with schedule as laboratory processing is dependent on patient/donor conditions, product/sample availability, age of collected cells as well as procedural modifications required to adapt to variable nature of incoming cellular products/samples. Working late nights, weekends and holidays with very short advance notice may be required.
* 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. Assist other specialists/associates/technicians in timely completion of documentation and assist supervisor in review and qualification of data and reports.
* Perform quality control testing, equipment routine maintenance and advanced troubleshooting. Stem cell and cell therapy products are unique; therefore, specialist must be able to rescue products in the event of equipment malfunction during processing.
* Coordinate and manage supply inventory required for clinical procedures as well as assigned projects and validations.

Transfer Technology:
* Take lead role in completion of assigned projects and transfer of novel technologies, completion of validation of procedures and equipment, and writing/revising Standard Operating procedures.
* Serve as mentor and train technologists in processing procedures and daily operational processes. Serve as supervisor designee in his/her absence. Assist supervisor in completion of competency assessment and training documentation.
* Assist supervisors in daily laboratory functions such as scheduling of staff and procedures; identification, development and implementation of quality and process improvement projects.
* Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.

Perform other related duties as assigned.