Job Abstract

KEY FUNCTIONS

Cell Manipulation and Processing with Flow Cytometry Experience

1. Perform cell manipulation/evaluation procedures including Standard of Care (SOC), External Sponsored Protocols (ESPs), and More than minimally manipulated manufacturing procedure within the GMP facility following standard policies and procedures which include but not limited to stem cell and/or cellular product 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 who is responsible for the entire process on scheduled days required per protocol until product is infused into the patient.
   
   
2. 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.
   
   
3. Maintain aseptic and/or sterile technique during processing of products to ensure 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.
   
   
4. Perform error free calculations, including, but not limited to infusion cell doses, viabilities, dilutions and cell concentrations.
   
   
5. 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.
   
   

Product monitoring, receiving, storage and retrieval

1. Adjust to a flexible work 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. Requires to be in the presence of medications. Cell products are received from facilities around the world and therefore working late nights, weekends and holidays with very short advance notice may be required. Adaptability and flexibility to procedural and schedule changes to ensure timely preparation of products with highest possible quality.
   
   
2. Follow and adapt to procedures/policies implemented by internal or external study sponsors on 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.
   
   
3. 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.
   
   
4. Coordinate and manage supply inventory required for clinical procedures as well as assigned projects and validations.

Transfer Technology

1. Perform quality control testing, equipment routine maintenance, basic and advanced troubleshooting. Stem cell products are unique, if equipment malfunctions during processing, technologist must be able to rescue product. Participate in process and quality improvement projects.
   
   
2. Assist in transfer of novel technologies from other institutions and companies, validation of procedures and equipment, training of technologists and writing Standard Operating procedures.
   
   
3. Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.
   
   

Perform additional related duties as assigned.