Medical Lab Cl

Department Overview The Cellular Therapy Laboratory brings decades of expertise in hematopoietic cell transplantation and cellular therapies, advancing personalized medicine through the manufacture and processing of specialized cell products. The laboratory is FDA-registered and accredited by the Foundation for the Accreditation of Cellular Therapy (FACT). Our team of Medical Directors and highly skilled technical staff provides extensive experience in clinical testing and product development, ensuring the highest standards of quality and patient care.

The Medical Laboratory Scientist is a key member of the Cellular Therapy Laboratory and the broader healthcare team. This role is responsible for the processing of cellular therapy products and other human tissues supporting multiple clinical departments and centers at OHSU. The Medical Laboratory Scientist performs complex laboratory procedures requiring advanced technical judgment, sound decision-making, and the ability to work independently with minimal supervision.

This position requires a strong foundation in hematology, transfusion medicine, flow cytometry, immunology, and cellular therapy, particularly as they relate to the treatment of hematologic malignancies and other serious diseases. The incumbent is expected to adhere to all applicable institutional policies, including the Compliance Rules and Responsibilities of OHSU Hospitals and Clinics.

Function/Duties of Position Handles, stores, prepares, and distributes cellular therapy products for infusion or transplantation

Participates in the collection of bone marrow harvest in OHSU Operating Rooms

Cryopreserves cellular therapy products and other tissues using both manualtechniques and the Controlled Rate Freezer Thaws and assists in infusion of cellulartherapy products both in the laboratory and at the patient’s bedside· Handles and prepares tissues for storage and release, including autologous boneflaps, parathyroid tissue, and UNOS cadaveric vessels.

Prepares infectious disease marker panels for send out, reports on results andensures regulatory compliance with positive products

Performs cellular therapy product selection and/or depletion procedures using theMiltenyi CliniMACS Plus or Prodigy

Participates in the collection of solid tumor tissue for send out to Tumor InfiltratingLymphocyte Manufacture.

Receives cellular therapy products and other tissues from national and international transplant centers and manufacturers

Follows written procedures and policies.

Prepares samples for testing, including viability and colony forming unit (CFU) assays. Repeats analysis as necessary to ensure accuracy. Reports test results via computer and telephone.

Performs all computer functions using EPIC, OnBase and Microsoft Office applications – Access, Notebook, Excel

Follows regulatory standards and guidelines put forth by the Foundation for the Accreditation of Cellular Therapies (FACT) and the Federal Drug Administration (FDA).

The position participates in many clinical trials and research endeavors

Available for emergency action response in the event of a freezer or refrigeration malfunction or weekend processing.

Assists with miscellaneous technical administrative functions to support daily laboratory activities.

Maintains inventory of reagents and supplies.

Enters data into various registries including the CIBMTR

Performs validations, audits and other quality control data as delegated by the Laboratory Manager and/or Laboratory Director.

Trained by various external business partners in commercially approved Cellular Therapy Product handing – including use of online data portals.

Assists in cellular therapy product inventory control, including discard of cell product

Answers telephone requests for laboratory information and scheduling assistance.

Equipment Maintenance: calibrates, maintains, and troubleshoots laboratory instruments and procedures.

Performs and evaluates quality control data to determine functionality of instruments and procedures.

Completes competency training, review of the quality management plan, policy and procedure manuals, and safety review. Attends and participates in staff meetings and training sessions.

Attends and participates in staff meetings, Grand Rounds, and training sessions.

Participates in internal process improvements and research projects, including Abstract and Manuscript development. · Follows current good tissue practices (cGTP) and current good laboratory practices (cGLP)

Required Qualifications Bachelor's degree in medical technology, Clinical Lab Science, Medical Laboratory Science, Chemical or Biological field, and current certification MT (ASCP), or MLS (ASCP) within 90 days of hire. Current certification and credential maintenance must be maintained for individuals who were certified after January 1, 2004. Completion of a 2-year accredited Medical Laboratory Technician program, plus MLT (ASCP) or equivalent certification within 90 days of hire, and 4 years of experience in a clinical laboratory. Current certification and credential maintenance must be maintained for individuals who were certified after January 1, 2004. Bachelor's degree in a Chemical or Biological field, and four years’ experience as a Medical Laboratory Technician in a clinical laboratory performing testing and related tasks. Current certification and credential maintenance must be maintained for individuals who were certified after January 1, 2004.Note: experience in a specialty lab area will only qualify candidate to work in that specialty area.

Preferred Qualifications FACT Regulatory Standards

Cellular Therapy Laboratory Experience

We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington.