Clinical Cell Therapy Associate

About the Role

The Clinical Cell Therapy Associate supports the mission of The University of Texas MD Anderson Cancer Center by assisting with complex, highly specialized, and time-sensitive technical cell manipulation and testing procedures for life-saving cellular products used in stem cell transplantation and cellular therapy. This role works within the Cord Blood Bank Program, a laboratory environment focused on the safe handling, processing, storage, and release of irreplaceable cellular products critical to patient care. The Clinical Cell Therapy Associate plays a vital role in ensuring the quality, safety, and regulatory compliance of cellular therapy products.

Key Responsibilities

• Cell Manipulation and Processing

• Perform cell manipulation/evaluation procedures following standard policies and procedures, including 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.

• Maintain aseptic technique during processing of products to ensure the integrity, viability, and sterility of cellular products.

• Adhere to special cleaning and gowning requirements for the facility and may be required to work in a clean room environment requiring specialized gowning.

• Successfully complete annual competency evaluations, including media fill, and proficiency testing for all procedures.

• Perform error-free calculations, including infusion cell doses, viabilities, dilutions, and cell concentrations, utilizing downtime procedures and worksheets when necessary.

• 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, and colony forming unit enumeration for both fresh and frozen cord blood units.

• Product and Sample Accessioning, Storage, Retrieval, and Shipment

• Retrieve cord blood product samples while maintaining cryogenic temperatures for internal quality assessments and preparation for shipment to reference laboratories.

• Create requisition orders and prepare patient and cord blood samples for transport to reference laboratories for identification, typing, and infectious disease testing.

• Prepare and catalog reference samples for stored products to meet regulatory requirements and support potential future testing, ensuring proper storage and documentation of storage locations and retrieval conditions.

• Receive and test sterility samples generated during production of HPC, Cord Blood, or other cellular therapeutic products, as well as reagents and media.

• Coordinate the testing for positive sterility samples and prepare associated documentation for transport to microbiology reference laboratories.

• Retrieve and prepare for shipment of product and associated reference samples to transplant centers, ensuring unit identification and verification, and completion of all associated documentation.

• Verify dry shippers meet all requirements prior to use.

• Prepare cord blood units not meeting specifications for clinical banking for transport to research facilities, ensuring disposition reports are approved and transport documents match units.

• Retrieve and discard frozen cord blood units and associated samples for products disapproved for research or clinical banking, verifying documentation and generating disposition reports.

• Maintain 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 activation.

• Quality Control: Equipment, Records, Controlled Documents, and Validations

• Manage supply inventory, verify expiry dates prior to use, and utilize a validated inventory control application for critical supplies.

• Prepare and perform qualification of reagents and media, and maintain concurrent documentation of all activities.

• Perform environmental monitoring for room qualification and ongoing verification of clean room spaces, collecting air particle counts and enumerating colonies.

• Prepare reporting and notify QA and management of alert and alarm level counts for environmental monitoring activities.

• Perform facility, room, and equipment quality control procedures daily, weekly, and monthly, as well as equipment routine maintenance and troubleshooting.

• Assist with the receipt, testing, and reporting for environmental cultures.

• Utilize computer systems and databases to enter, retrieve, and compile data, complete laboratory records, and prepare reports.

• Perform procedures and maintain accurate documentation in compliance with FDA's Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Tissue Practices (GTP) regulations, and standards set by accreditation agencies.

• Document deviations and events, notify supervisor and management in a timely manner, and assist in investigations and corrective actions.

Requirements & Tech Stack

• Cell Manipulation and Processing
• Flow cytometry
• cGMP cell therapy laboratory experience is preferred
• Aseptic technique
• Clean room environment
• FDA's Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)
• Good Tissue Practices (GTP)
• FACT/Netcord
• CAP accreditation standards

Qualifications

• Required:
• Bachelor's degree in a relevant scientific field.
• Preferred:
• One year of prior experience in a cell therapy or clinical laboratory.
• Experience with flow cytometry.
• Experience in a cGMP cell therapy laboratory.
• Strong attention to detail.
• Ability to accurately follow complex technical procedures.
• Comfortable working in highly regulated laboratory and cleanroom environments.
• Adaptability to changing schedules.
• Meticulous in documentation.
• Commitment to adhering to regulatory and quality standards.

Work Schedule

• Variable shifts, may be assigned to Evening shifts.
• Hours may be changed to one of several variable shifts during lab operation hours with advanced notice.
• This position is 100% onsite.

Compensation

• Hourly Range: Minimum $24.27 - Midpoint $30.28 - Maximum $36.29