The primary purpose of the Cell Therapy Lab Supervisor position is to provide leadership and support for all initiatives in the TIL laboratory at South Campus Research building & in the GMP suites. To train the clinical cell therapy specialists to be able to work independently to perform complex, highly specialized and time sensitive technical cell manipulations and testing procedures on irreplaceable, life saving cellular products used for treatment of cancer patients undergoing either turnstile 1 or 2 treatment under the TIL protocol. The Cell Therapy Lab Supervisor will report directly to a Clinical Research Scientist to ensure all TIL initiatives and projects progress from the initial planning stages to completion in the clinical settings.* Key Functions*
1. Cell Manipulation and Processing
1. Train all Clinical Cell Therapy Specialist (CCTS) to perform cell manipulation/evaluation procedures following standard policies and procedures which include but not limited to cellular product cryopreservation, cell culture, cell product thaw/infusion, etc. 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) CCTS technologist who is responsible for the entire process on scheduled days required per protocol until product is infused into the patient.
1. Train all Clinical Cell Therapy Specialist (CCTS) on maintaining accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Manufacturing/Good Tissue practice regulations as well as standards set by other accreditation agencies. Training on how to 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.
1. Supervise the CCTS to validate proper aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until final infusion to the patient. Making sure the CCTS adhere to special cleaning and gowning requirements for both the SCRB & GMP facility.
1. Reviews cell processing documentation for completeness. Make sure the CCTS perform error free calculations when dealing with patient products in GMP and SCRB. Verify folders for accuracy in reporting. Ensures that appropriate material is being submitted for quality testing and that results are filed appropriately in folder. Finalize patient folders before Quality Assurance audits.
1. Serve as a mentor in increasing efficiency in advanced cell processing, new technologies & laboratory techniques and adapting the procedures/policies towards implementation.
1. Assists in processing when needed. Workload in TIL lab is variable and Cell Therapy Lab Supervisor has to ensure proper staffing and task distribution, including performing part of the processing if needed.
1. Product monitoring, receiving, storage and retrieval
1. Help the CCTS adjust to a flexible work schedule dependent on patient conditions and product/sample availability is required. Cell products are received at any given time with very short advance notice and late night or weekend work may be required. The Cell Therapy Lab Supervisor will make sure all procedures/products have coverage when needed & that the proper amount of support will be available. The Cell Therapy Lab Supervisor will work with the Clinical Research Scientist on all validation & time sensitive procedures so the CCTS schedule is worked out in a timely manner and that the preparation of products will be processed with highest possible quality.
1. Utilize various computer systems and databases to enter, retrieve and compile data, complete patient laboratory records and prepare reports for review by the TIL Director and Quality Assurance personnel.
1. Oversee the coordination and management of supply inventory required for clinical procedures as well as assigned projects and validations.
1. Transfer Technology and Quality control
1. Train CCTS to perform quality control testing, equipment routine maintenance, basic and advanced troubleshooting. TIL patient products are unique; if equipment malfunctions during processing, technologist must be able to rescue product. The Cell Therapy Lab Supervisor will also participate in process and quality improvement projects.
1. The Cell Therapy Lab Supervisor will assist the Clinical Research Scientist in the transfer of novel technologies from translational research to the clinical setting. Validations of procedures and equipment, training of technologists and writing Standard Operating procedures.
1. The Cell Therapy Lab Supervisor will also communicate with physicians/investigators and nurses to ensure timely quality patient care. Proper communication between the clincial staff is key. The supervisor will work with the physicians/nurses and also the SCTCT clinical staff to ensure all patient care is priority and carried out in a timely manner.
Job Description - Requirements EDUCATION
Required: Bachelor's degree in a relevant scientific field.
EXPERIENCE
Required: Three years of experience in clinical processing of cellular products and previous lead/supervisor experience.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
*Supv, Cell Therapy Lab*
*5813BR*
*Houston