A Brief Overview Hours worked are 8:30 am - 5:00 pm Position is located in the Wolstein Seidmen Cancer Center Under minimal supervision, this position 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.
With minimal supervision, performs a variety of duties related to the processing of cellular therapy products according to standard operating procedures. Processes stem cells from initial evaluation to finished product status in an accurate and timely manner using aseptic techniques. Prepares cellular products for infusion under appropriate regulatory and quality guidelines.
Interfaces regularly with nurses, coordinators and physicians to prepare cell products for patient treatment according to physician’s orders. Assists clinical staff during the infusion of cellular therapy products. Prepares appropriate documentation for processing and infusion records.
Achieves and maintains competency in common lab procedures including aseptic technique, cryopreservation/thawing, cell selection, centrifugation, and washing. Demonstrates proficiency with lab equipment required for the processing of human products. Interprets test results, including: automated and manual cell counts, viability, flow cytometry, infectious disease marker panels, and sterility testing.
Performs patient dose calculations during processing to assess product yields. Labels cell products while maintaining chain of custody and identity in collaboration with the clinical and product transport teams. Works as part of a team to correlate data based on results, technical expertise, and other conditions affecting test results or process outcomes.
Takes the lead on the validation and development of new procedures to optimize processes. Enters and maintains records of procedures and data, both manually and on electronic data capture systems. Reviews records for acceptability, accuracy, and completeness.
Documents procedures according to Good Documentation Practice guidelines. Ensures equipment, reagents and supplies are properly utilized and performs reagent and instrument quality control at the appropriate intervals, interpreting and recording results. Ensures equipment undergoes preventative maintenance and calibration on a regular schedule.
Utilizes reagents and supplies in accordance with manufacturer guidelines and/or standard operating procedures. Reviews critical reagents and supply receipts, storage, and applicable manufacturer certificate of analysis or conformity prior to use. Ensures effective collection and shipment/receipt of cell products with appropriate documentation.
Performs supply procurement and billing of executed procedures. Maintains a well-organized, stocked, and clean work area. Monitors inventory levels ensuring adequate supplies.
Tends to cell product storage in liquid nitrogen 24/7 to ensure products are not compromised by thaw prior to infusion. Demonstrates and maintains knowledge of quality, safety, and compliance programs while maintaining records to meet standards/requirements of the hospital and licensing/accrediting agencies including, but not limited to, FDA, FACT, CAP, and CLIA. Adheres to departmental guidelines, safety/regulatory requirements, and applicable regulatory and quality standards.
Provides a safe environment for patients. 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.
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. Education Bachelor's Degree In biological science, clinical lab science or another health related field (Required) Work Experience 5+ years Expereince in a clinical, analystial or biotech lab.
(Required) and 5+ years Experience in aseptic technique, quality and regulatory compliance and a highly regulated environment. (Preferred) Knowledge, Skills, & Abilities Familiarity with laboratory equipment (Required proficiency) Knowledge of FDA, cGMP, and cGTP (Required proficiency) Exhibits excellent organizational, planning, and time management skills (Required proficiency) Good judgement, critical thinking skills, and problem solving abilities (Required proficiency) Excellent written, verbal, and interpersonal communication skills (Required proficiency) Extreme attention to detail (Required proficiency) Capable of working in a fast-paced and rapidly changing environment and technology (Required proficiency) Working knowledge of Microsoft Word, Excel, and PowerPoint (Required proficiency) Licenses and Certifications Medical Technologist (MT-ASCP) (Preferred Upon Hire) Physical Demands Standing Frequently Walking Frequently Sitting Rarely Lifting Frequently 50 lbs Carrying Frequently 50 lbs Pushing Frequently 50 lbs Pulling Frequently 50 lbs Climbing Occasionally 50 lbs Balancing Occasionally Stooping Frequently Kneeling Frequently Crouching Frequently Crawling Occasionally Reaching Frequently Handling Frequently Grasping Frequently Feeling Constantly Talking Constantly Hearing Constantly Repetitive Motions Constantly Eye/Hand/Foot Coordination Constantly Travel Requirements 10%