Cellular Therapy Lab Specialist

Community Health Network•Indianapolis, IN

About The Position

The Clinical Cellular Therapy Lab Specialist performs highly specialized, time-sensitive technical cell manipulation and testing procedures on irreplaceable cellular products used to treat cancer patients undergoing stem cell transplantation and/or cellular therapy. The role supports the integrity, viability, sterility, and timely preparation of cellular products for infusion, while following applicable procedures, regulations, and accreditation standards. Duties may vary, and additional related responsibilities may be assigned.

Requirements

Associate degree in chemical or biological science, clinical laboratory science, or medical technology, or an equivalent combination of education and experience.
At least 2 years of experience as a technician in a clinical laboratory setting.
Certification as a professional Medical Laboratory Technologist (MT-ASCP, MT-AAB, or MT-AMT), or equivalent certification in the area of specialty; Medical Laboratory Scientist (MLS) (ASCP) is also listed.
Ability to perform accurate calculations and follow technical, documentation, aseptic, and sterile procedures.

Nice To Haves

Bachelor's degree in chemical or biological science, clinical laboratory science, or medical technology.
At least 1 year of experience in clinical cell processing.

Responsibilities

Perform cell manipulation and evaluation procedures, including stem cell and/or cellular product cryopreservation, cell enrichment, product thawing and washing, and infusion.
Perform procedures and maintain accurate documentation in compliance with FDA Good Laboratory Practices, Good Manufacturing Practices, Good Tissue Practices, and applicable accreditation standards, including FACT, FACT/Netcord, CAP, and CLIA.
Document deviations and events, notify supervisory, technical, and quality management personnel promptly, and assist with investigations and corrective actions.
Maintain aseptic and/or sterile technique and follow facility cleaning and gowning requirements to protect cellular product integrity, viability, and sterility.
Perform calculations, including infusion cell doses, viabilities, dilutions, and cell concentrations.
Maintain and apply knowledge of stem cell transplantation and cellular therapies, including procurement, processing, testing, storage, and transplantation.
Apply knowledge of cell sources, donor evaluation, screening and testing, labeling, product acceptability, and release criteria.
Adapt to varying incoming cellular products and samples, and participate in product receipt, storage, and transport for infusion.
Follow external company procedures and policies for commercial cell therapy products, including product-specific processing and documentation requirements.
Use computer systems and databases to enter, retrieve, and compile data, complete patient laboratory records, and prepare reports for laboratory directors, quality assurance, and physicians.
Coordinate and manage supplies needed for clinical procedures, projects, and validations.
Review and evaluate monitoring alarm system reports, notify the appropriate manager or designee of excursions, and participate in the on-call rotation when excursions put products at risk.
Work a flexible schedule as needed to prepare products on time and maintain quality.
Perform quality control testing, routine equipment maintenance, and basic and advanced troubleshooting.
Participate in process and quality improvement projects and assist with procedure and equipment validation.
Participate in writing Standard Operating Procedures.
Perform routine environmental monitoring and equipment maintenance at designated intervals.
Communicate with physicians and investigators, nurses, donor coordinators, internal and external testing laboratories, and transplant facilities to support timely quality patient care.