Cell Therapy Lab Specialist - University Hospitals
Cleveland, OH
About the Job
Description
A Brief Overview
Under moderate supervision, the Cell Therapy Lab Specialist performs technical processing procedures, associated quality functions, and lab maintenance related to autologous and allogeneic hematopoietic progenitor cells (HPC) and novel therapeutic cellular therapy products to treat patients within the Seidman Cancer Center Hematopoietic Malignancy and Cellular Therapy Program and Wesley Immunotherapy Center. Primary responsibilities include: preparing materials, equipment, operating and monitoring cell processing instruments, conducting in-process sampling, following SOPs and cGMP guidelines and maintaining supply/reagent inventories within an environment that requires good aseptic technique. Receives and tracks patient samples, assists with routine QC assays and general upkeep of the lab.
What You Will Do
- Provides safe outcomes for patients when handling cellular products. Reports safety concerns, errors, and near misses related to cellular products for administration.
- Participates in the Lab Quality Management Program designed to ensure patient safety by process control and prevention of errors. Performs environmental monitoring checks to maintain a GMP environment.
- Performs a variety of duties related to the processing of cellular therapy products according to standard operating procedures. Prepares production suites with materials, equipment and documents. Provides daily, hands-on support for production of cell-based therapies.
- Follows SOPs and exhibits good documentation practices (GDP) used in the preparation of patient products. Utilizes reagents and supplies in accordance with manufacturer guidelines and/or standard operating procedures.
- Maintains a well-organized, stocked, and clean work area. Monitors inventory levels ensuring adequate supplies.
- Ensures effective collection and receipt/shipment of cell products with appropriate documentation. Performs supply procurement and billing of executed procedures.
- Tends to cell product storage in liquid nitrogen 24/7 to ensure products are not compromised by thaw prior to infusion.
- Demonstrates ability to understand quality systems, safety, and compliance programs while maintaining records to meet standards/requirements of the FDA, CLIA, FACT, and other applicable bodies.
- Assists in performance of validations of new procedures under supervision to optimize processes and/or reduce costs.
Additional Responsibilities
- Performs other duties as assigned.
- Complies with all policies and standards.
- For specific duties and responsibilities, refer to documentation provided by the department during orientation.
- Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications
Education Qualifications
- Associate's Degree in a Biotechnology or Medical Laboratory Science (Required) or
- Bachelor's Degree in Biological Science, Medical Laboratory Science, or another related field (Required)
Experience Qualifications
- 1+ years of experience in a research or clinical laboratory environment (Required) and
- less than 1 year Familiarity with laboratory techniques, procedures and laboratory equipment (Required) and
- less than 1 year Experience in aseptic, molecular and cell culture techniques (Preferred)
Skills and Abilities
- Excellent organizational, planning, attention to detail and time management skills (Required proficiency)
- Excellent written, verbal, and interpersonal communication skills (Required proficiency)
- Ability to work in a fast-paced and rapidly changing technology and environment (Required proficiency)
- Microsoft Word, Excel, and PowerPoint skills (Required proficiency)
