MD Anderson Cancer Center Clinical Cell Therapy Trainer - Stem Cell Transplantation Lab in Houston, Texas
The primary purpose of thisposition is to have a comprehensive knowledge and be able to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable, lifesaving cellular products used for treatment of cancer patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment. This position will provide hands on training and mentoring to the Cell Therapy technical team members.
Documentation - Training
Complete and maintain accurate documentation of all training records including training objectives and competencies following applicable regulations and prepare reports for leadership and quality assurance review.
Coordinate and track all training documentation. Retrieve and provide updates to laboratory leadership, quality assurance and other laboratory staff in timely manner.
Perform regular audits of training records to ensure compliance with laboratory and hospital regulatory bodies.
Perform routine reviews of the training records at designated time intervals. Track and coordinate timely completion of training and competency records with respective team members and laboratory leadership.
Maintain accurate training records for all team members of the laboratory including related records and documentation.
Assist in the creation of new standard operating procedures and validation of new assays/equipment/supplies.
Attend continuing education programs and participate in process and quality improvement projects.
Cell Manipulation and Processing - Training
Maintain technical knowledge of 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.
- Maintain technical knowledge of procedures and equipment and be able to initiate and assist Cell Therapy Specialists in troubleshooting steps.
- Maintain technical knowledge of calculations which include but not limited to infusion cell doses, viabilities, dilutions and cell concentrations.
- Maintain technical knowledge 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 be able to demonstrate special cleaning and gowning requirements for the facility including requirements to work in clean room environment requiring specialized gowning such as masks/goggles, sterile jumpsuits, hair and shoe covers.
- Maintain knowledge of procedures and required documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, and Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, FACT/Netcord, CAP, CLIA. Must understand and be able to train staff on how to document deviations and events, while notifying supervisor, technical and quality management personnel in timely manner and assisting in investigation of cause and any required corrective actions.
Maintain extensive 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 when training others regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
Product monitoring, receiving, storage and retrieval - Training
Participate and train others in a manner that emphasizes the importance of following and adapting 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.
- As a trainer must 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. 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.
- Must be able to demonstrate the use of 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. Train staff in timely completion of documentation and assist supervisor in review and qualification of data and reports.
- Train cell therapy lab staff on the performance of 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.
Train cell therapy staff on the required supply inventory required for clinical procedures as well as assigned projects and validations.
Participate as a trainer in the 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.
- 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.
Required: Bachelor's degree in a relevant scientific field.
Required: Three years of experience in clinical cell processing.
Preferred: Five years of experience in clinical cell processing.
Preferred: Certified Medical Technologist (MT) or Medical Laboratory Scientist by the American Society of Clinical Pathologist (ASCP)
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
Requisition ID: 144095
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Day/Evening
Fund Type: Hard
Pivotal Position: No
Minimum Salary: US Dollar (USD) 85,000
Midpoint Salary: US Dollar (USD) 106,250
Maximum Salary : US Dollar (USD) 127,500
Science Jobs: No