Position type: Full time
Required education: Bachelor's Degree
Area(s) of expertise desired: Laboratory, Cell Culture, Cell Biology

Overview
Under the direction of the Processing Supervisor, the Cellular Therapy Specialist I processes, cryopreserves, and otherwise manipulates cell products using sterile techniques, according to written Standard Operating Procedures, in accordance to facility cGMP practices. Facility and personnel specific duties will be regulated by client procedures being performed at each Cellular Production Facility.

ESSENTIAL FUNCTIONS

1. Performs any and all required processing and testing required to produce and assess safe and efficacious products. Performs additional duties as assigned.
2. Fulfills duties of this position at expected levels of competency as outlined in the Competency/Proficiency polices.
3. Proficiently functions within a Class 100,000 and or Class 10,000 clean room environment, ensuring personal and product safety.
4. Consistently produce a high level of documentation accuracy and clarity.
5. Proficiently performs testing to assess product content and safety according to designed procedures. Depending on the CPS I assigned responsibilities these could include but not limited to testing: nucleated cell counts, viability, WBC slide differential, sterility sampling, tissue culture, flow cytometry, endotoxin testing, Gram stain, and PCR.
6. Cryopreservation of products using DMSO solutions and rate-controlled freezers.
7. Proficiently operate equipment according to designed procedures. Depending on the CPS I assigned responsibilities this equipment could,
   include but is not limited to the COBE 2991 cell washer, Cell Counters, controlled-rate freezers, temperature monitoring systems, alarm systems laminar flow hoods, CO2 incubators, liquid nitrogen freezers, microscopes, centrifuges, flow cytometers, optical plate readers, pipets, gene amplifiers.
8. Perform the monitoring and maintenance of critical equipment such ultra-cold freezers, storage tanks, refrigerators, freezers, and incubators.
9. Manipulate products according to established standard operating procedures such as enrichments, depletions, or volume reductions to achieve pre-determined endpoints. Specific projects require:
   a. Volume reduction using centrifugation and plasma depletion.
   b. RBC depletion for incompatible allogeneic marrow, or for cryopreservation of autologous or allogeneic marrow.
   c. CD34 enrichment/selection using density-gradient centrifugation or commercial devices.
   d. Preparation of mononuclear cell fraction using ficoll.
   e. Purging or depletion of cell populations using monoclonal antibodies and complement, depletion devices, or cytotoxic substances.
   f. Thawing cryopreserved hematopoietic progenitor cell products either at the Clinical Site or in the facility as specified by protocol.
10. Participating in clinical trial support and studies, may include but not limited to:
    a. Sample preparation
    b. Sample shipping
    c. Media and reagent preparation
    d. Ordering and receiving supplies.
    e. Communicating effectively with other departments and clinical staff, including apheresis, clinical laboratory, attending physicians, research fellows, and unit nurses.
11. Performing facility and equipment duties such as the quality control, periodic maintenance, and preventative maintenance, for applicable methods and equipment, reporting facility and equipment problems to supervisor, trouble shooting facility and equipment problems as specified in SOP. Performing Environmental Monitoring of the facility.
12. Sharing on-call responsibilities.

Requirements
A relevant college degree and/or applicable experience in; a clinical laboratory, hematology, blood banking, immunology, or cGMP manufacturing. Cell processing experience is preferred A current Medical Technologist license may be required. Demonstrates tact and courtesy in dealing with others.