Job Details

• Follows, understands and adheres to all appropriate Standard Operating Procedures (SOPs) and complies with cGTP and cGMP regulatory requirements. May assist in evaluating and writing SOPs.
• Processes and cryopreserves autologous and allogeneic cellular therapy products: Peripheral Blood Stem
• Cells (PBSC), Donor Lymphocytes (DLI), using aseptic techniques.
• Performs applicable flow cytometric assays (high complexity), CBC’s (moderate complexity), viabilities (high complexity), Colony Forming Units (CFU) assay (High complexity testing) and BacT-ALERT (moderate complexity testing) using appropriate level of complexity of mathematical and laboratory skills resulting in error-free calculations and products. Recognizes deviations from expected testing results and takes appropriate action.
• Transports irreplaceable products directly from patient/hospital to lab for processing and the specialized cellular therapy products to patient for infusion.
• Performs bedside thaws of cellular therapy products, providing direction to nurses and answering nurse and patient questions as needed.
• Regularly communicates and partners with internal and partner physicians, management and nursing staff regarding needed testing and testing results.
• Evaluates incoming cord blood donors and cord blood products, qualifying units and documentation for acceptance.
• Responsible for drafting cellular therapy reports, providing technical and succinct explanation of results.
• Operates laboratory equipment correctly and performs quality control testing of equipment and reagents (daily, weekly, monthly, quarterly, semi-annual, and annual maintenance maintenance).
• Drafts and performs equipment and process validations.
• Performs training of new staff and new procedures
• Additional duties as needed.
• Performs other duties as assigned
• Complies with all policies and standards

Education

• Bachelor's Degree Bachelor of Science degree from an accredited college or university in Clinical Laboratory Science/Medical Technology (MLS/CLS/MT) or science related degree (biology, chemistry, molecular biology, immunology, or related field) required
• Must be able to meet CLIA requirements for high complexity testing required

Experience

• 1-3 years related experience and/or training; required
• equivalent combination of education and experience. required

Knowledge, Skills and Abilities

• Skill in the operation of laboratory equipment, instrument, computer and materials. required
• Effective time managing and organizational skills to perform multiple laboratory tests simultaneously. required
• Maintain accurate, timely records of patient/donor information and laboratory results required
• Strong detail orientation and analytical ability to evaluate and ensure accuracy of data related to laboratory results and patient/donor information. required
• This person must have the ability to work independently with minimum supervision; multi-task; work with confidential information; and work under high stress or pressure situations and with tight deadlines. required
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of algebra. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. required
• Weekend on-call rotation once competent in processing auto/allo PBSC. Evening and weekend work may be required. Evening and weekend work may vary based on the individual staffing needs of the department. required
• Ability to read and interpret documents such as Standard Operating Procedures, safety rules, operating and maintenance instructions, and other department manuals. required
• Ability to apply judgment to detailed but very structured written or oral instructions and to deal with problems involving concrete variable in standardized work procedures. required
• Able to organize work to provide productive workflow needed in component preparation. required