Cell Therapy Specialist I

Children's Hospital of Philadelphia
United States, Pennsylvania, Philadelphia
Feb 06, 2025
SHIFT: Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career. CHOP's Commitment to Diversity, Equity, and Inclusion CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage all candidates of diverse backgrounds and lived experiences to apply. A Brief Overview The Cell and Gene Therapy Laboratory (CGTL) is a FACT accredited laboratory that processes cellular products for routine bone marrow transplantations (BMT) and for the use in multiple investigational and experimental clinical trials. Under the direction of the Supervisor of the CGTL, the Cell Therapy Specialist is responsible for performing technical procedures on cellular therapy products including plasma reduction, red cell reduction, cryopreserving, thawing, and issuing cell products for patient infusions. The Cell Therapy Specialist will also participate in processing cellular therapy products for investigational clinical trials including TCR Alpha Beta depletions, CD34 selections, and CAR-T and viral CTL manufacturing. New protocols and procedures are almost guaranteed given the rapidly expanding field of cell and gene therapy. The Cell Therapy Specialist will be trained in all technical areas of the laboratory including cell counting, flow cytometry, and product release testing. The Cell Therapy Specialist participates in quality maintenance program for products, reagents, and equipment to meet GMP/GTP standards and satisfy regulatory requirements (FACT, CAP, FDA, JCAHO). The Cell Therapy Specialist also shares certain responsibilities in the management of the laboratory as assigned. This job requires some flexibility in working hours to support patient care. What you will do Processes hematopoietic progenitor cell (HPC), immune effector cell, and other cell therapy products according to defined SOPs. Procedures include but not limited to plasma reduction, red cell reduction, cryopreserving, thawing, and issuing cell products for patient infusions. Achieves and maintains competency in cell product cryopreservation, thawing, washing, selection/depletion, storage, labelling and transportation. Handles research products according to sponsor provided manuals and internally developed processes. Responds to requests for cellular products and manages communications related to coordination and fulfillment of requests across program. Escalates the issues to the Cell Therapy Specialist II, Lead Specialist or Lab Supervisor. Performs and accurately documents analytical tests such as flow cytometry, endotoxin testing, mycoplasma testing, hematology analysis, sterility testing. Complies with institutional and laboratory polices, practices, SOPs and applicable regulations, requirements, and standards (GTP/GMP, FACT, CAP, FDA). Performs daily quality control on all equipment prior to use and conducting routine preventative maintenance as required. Maintains patient records, both manually and computer-based. Supports Supervisor in documenting events, deviations and occurrences and timely notifying staff supervisor. Communicates with staff members regarding manufacturing materials, products inventory and reports. Performs environmental monitoring of the laboratory. Responding to REES alarm system and correcting the controlled parameters if necessary. Identifies improvements to laboratory operations; Performs other related tasks as necessary Education Qualifications Bachelor's Degree biology, medical laboratory science, or similar filed of study Required Experience Qualifications At least six (6) months experience in tissue culture techniques and understanding basic techniques in cell biology and immunology Required At least two (2) years relevant laboratory experience Preferred Skills and Abilities Able to work independently with minimum supervision within established SOPs Able to adjust to flexible schedule or varied hours Competent to work with computers (word processing, database, and spreadsheet programs). Able to perform complex mathematical calculations Communicate effectively and professionally with other lab staff and health care providers involved in the patient's care. Licenses and Certifications Medical Technologist (MT) - American Society for Clinical Pathology (ASCP) - upon hire - Preferred To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more. Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed. EEO / VEVRAA Federal Contractor \| Tobacco Statement