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Cell Therapy Laboratory Associate Specialist

2 months ago

Cleveland, Ohio, United States University Hospitals Full time
Job OverviewPosition SummaryGeneral Description

This role involves performing essential technical processing tasks, quality assurance functions, and laboratory upkeep related to both autologous and allogeneic hematopoietic progenitor cells (HPC) as well as innovative therapeutic cellular products aimed at treating patients within the University Hospitals' Hematopoietic Malignancy and Cellular Therapy Program.

Key Responsibilities
  • Independently executes a range of tasks associated with the preparation of cellular therapy products in compliance with established operating procedures. Processes stem cells from initial assessment to final product status with precision and timeliness while employing aseptic techniques. Prepares cellular products for administration following relevant regulatory and quality standards.
  • Collaborates consistently with nursing staff, coordinators, and physicians to prepare cell products in accordance with medical directives. Supports clinical personnel during the administration of cellular therapy products and ensures proper documentation for processing and infusion records.
  • Maintains proficiency in standard laboratory procedures, including aseptic technique, cryopreservation/thawing, cell selection, centrifugation, and washing. Demonstrates adeptness with laboratory equipment necessary for processing human-derived products.
  • Analyzes test outcomes, including automated and manual cell counts, viability assessments, flow cytometry, infectious disease marker panels, and sterility evaluations. Conducts patient dose calculations during processing to determine product yields.
  • Labels cellular products while ensuring chain of custody and identity in partnership with clinical and transport teams.
  • Functions as part of a collaborative team to interpret data based on results, technical knowledge, and other factors influencing test outcomes or processing results. Takes initiative in the validation and development of new methodologies to enhance operational efficiency.
  • Records and maintains procedure and data logs, both manually and electronically. Reviews documentation for accuracy and completeness, adhering to Good Documentation Practices.
  • Ensures proper utilization of equipment, reagents, and supplies, conducting quality control checks at designated intervals and interpreting results. Oversees routine maintenance and calibration of equipment.
  • Utilizes reagents and supplies according to manufacturer guidelines and standard operating procedures. Reviews critical reagent and supply documentation prior to usage.
  • Facilitates the effective collection and shipment of cell products with appropriate documentation. Manages supply procurement and billing for completed procedures. Maintains an organized, stocked, and sanitized workspace while monitoring inventory levels.
  • Oversees the storage of cell products in liquid nitrogen continuously to prevent compromise prior to administration. Demonstrates and upholds knowledge of quality, safety, and compliance protocols while maintaining records to meet the standards of the hospital and relevant accrediting bodies.
  • Adheres to departmental protocols, safety regulations, and applicable quality standards, ensuring a safe environment for patients. Reports any safety issues, errors, or near misses related to cellular products for administration. Engages in the Lab Quality Management Program aimed at ensuring patient safety through process control and error prevention.
Additional Duties
  • Performs other assigned responsibilities.
  • Complies with all institutional policies and standards.
  • For specific duties and responsibilities, refer to departmental documentation provided during orientation.
  • Must adhere to all regulations regarding the secure handling of Protected Health Information (PHI) for patients.
QualificationsEducation
  • Bachelor's Degree in biological sciences, clinical laboratory science, or a related health field (Required)
Work Experience
  • 5+ years of experience in a clinical, analytical, or biotechnology laboratory (Required)
  • 5+ years of experience in aseptic techniques, quality assurance, and regulatory compliance in a highly regulated environment (Preferred)
Knowledge, Skills, & Abilities
  • Familiarity with laboratory equipment (Required proficiency)
  • Knowledge of FDA regulations, cGMP, and cGTP (Required proficiency)
  • Demonstrates strong organizational, planning, and time management skills (Required proficiency)
  • Exhibits sound judgment, critical thinking, and problem-solving abilities (Required proficiency)
  • Excellent written, verbal, and interpersonal communication skills (Required proficiency)
  • High attention to detail (Required proficiency)
  • Able to thrive in a fast-paced and evolving technological environment (Required proficiency)
  • Proficient in Microsoft Word, Excel, and PowerPoint (Required proficiency)
Licenses and Certifications
  • Medical Technologist (MT-ASCP) upon hire (Preferred)
Physical Demands
  • Standing: Frequently
  • Walking: Frequently
  • Sitting: Rarely
  • Lifting: Frequently up to 50 lbs
  • Carrying: Frequently up to 50 lbs
  • Pushing: Frequently up to 50 lbs
  • Pulling: Frequently up to 50 lbs
  • Climbing: Occasionally up to 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%