Clinical Cell Therapy Associate - Cord Blood Bank Program

The primary purpose of the Clinical Cell Therapy Associate position is to assist in the performance of complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable, life-saving cellular products used for treatment of cancer patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment.

**Shift: Mon-Fri or Tues-Sat, 8 hour shift, 40 hours/week. Shift hours will be determined after training period based on business need within current lab hours of 7am to 11pm, Mon-Sat. Shift differentials available for evening and weekend hours.**

CELL MANIPULATION AND PROCESSING

• Perform cell manipulation/evaluation procedures 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, and cell product thaw/wash. Complete responsibility and awareness is required while performing procedures which may take a few hours for completion.
• Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products. 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 gloves, masks/goggles, sterile jumpsuits, scrubs, lab jackets, disposable lab coats, hair and shoe covers, as well as clean room shoes.
• Successfully complete annual competency evaluations, including media fill, and proficiency testing for all procedures with established competency.
• Perform error free calculations, including, but not limited to infusion cell doses, viabilities, dilutions and cell concentrations. Must be able to perform required calculations utilizing down time procedures and worksheets.
• Perform procedures and assays designed to characterize the product and/or evaluate against specifications such as cell counts, sterility testing, flow cytometry for viability and enumeration, colony forming unit enumeration for both fresh and frozen cord blood units.

• Retrieve cord blood product samples while maintaining cryogenic temperatures for internal quality assessments as well as to prepare samples for shipment to reference laboratories for confirmatory typing or additional screening for use in cell therapy and transplant.
• Create requisition orders and prepare patient and cord blood samples for transport to reference laboratories for identification (HLA), typing (AbO/RH) and infectious disease testing (Maternal blood samples).
• Prepare and catalog reference samples for stored products to meet regulatory requirements and support potential future testing. Ensure proper storage of samples based on sample type. Documentation of storage locations and retrieval conditions, ensuring sample appropriate temperatures are maintained at all times.
• Receive and test sterility samples generated during production of HPC, Cord Blood, or other cellular therapeutic products, as well as reagents and media used in the manufacture of cellular therapeutic products. Coordinate the testing for positive sterility samples (clinical patient or cord blood samples). Create requisition orders and prepare sterility samples and associated documentation for transport to microbiology reference laboratories for identification/speciation. Notify reference lab of incoming specimens and request courier pickup. Notify QA of positive sample to reject the cord blood unit and stop further processing activities.
• Retrieve and prepare of shipment of product and associated reference samples to transplant center. Responsible for unit identification and verification as well as completion of all associated documentation. Verify dry shipper meets all requirements prior to use, including exterior labels, CVSI within acceptable range, no visible damage, and that the datalogger is functional. Ensure correct documentation is secured properly prior to release to courier.
• Prepare cord blood units not meeting specifications for clinical banking for transport to research facility. Ensure all rejected units have a disposition report and are approved to be released for research. Ensure transport document matches the units in the transport tote and that tote is secured prior to release to courier. Prepare associated cord blood processing documents for release upon request. Contact courier to arrange transport.
• Retrieve and discard frozen cord blood units and associated samples for products disapproved for research or clinical banking. Verify documentation and cord blood unit identification numbers match and generate disposition reports for all products for long term storage of associated records.
• Responsible for concurrent documentation of all sample storage, movement, retrieval and disposal in associated tracking applications, databases or quality records.
• Adjust to a flexible work schedule as laboratory processing is dependent on product/sample availability and scheduled patient procedures which may require on call shift activation. Adaptability and flexibility to procedural and schedule changes is required to ensure timely preparation of products with highest possible quality.

• Responsible for supply management, verification of expiry prior to use, first in/first out, creation of formulations using validated inventory control application for all critical supplies and supplies used for processing and testing procedures.
• Prepare and perform qualification of reagents and media used in the manufacture and testing of Cord Blood, as well as concurrent documentation of all activities.
• On an assigned rotation, perform environmental monitoring, static and dynamic, for room qualification and ongoing verification of clean room spaces. Collect air particle counts daily and document concurrently. Enumerate colonies for all TSA and SDA media plates. Prepare reporting and notify QA and management of alert and alarm level counts for all EM activities.
• Perform facility, room, and equipment quality control daily, weekly and monthly procedures, as well as equipment routine maintenance, basic and advanced troubleshooting. Responsible for quarterly cleaning of incubators and the documentation of all work concurrently.
• Assist with the receipt, testing and reporting for environmental cultures received in the CBB from SCTCT or other MD Anderson departments.
• Utilize various computer systems and databases to enter, retrieve and compile data, complete laboratory records and prepare reports for review by laboratory supervisors, quality assurance and Directors.
• 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 FDA, FACT/Netcord, and CAP.
• 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.

EDUCATION

Required: Bachelor's degree in a relevant scientific field.

EXPERIENCE

Required: None.

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