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Location: Oklahoma City, OK

Days: Monday through Friday; some weekends; some on-call

Hours: 8:00 a.m. to 5:00 p.m. (may vary)

Position:

The Manager, under the direction of the medical and laboratory directors, oversees the technical operations related to the provision of cell therapy products and services. The individual serves as an on-site subject matter expert for cellular therapy processing, cryopreservation, storage, and distribution.

Qualifications:

• Baccalaureate degree from a regionally accredited college/university and MT(ASCP) or BB(ASCP) or equivalent
• 3-5 years of experience in Cell Therapy &/or Cord Blood experience
• Familiar with current HPC and Cord Blood regulations and standards - AABB, FACT, FDA, NMDP, etc.
• Ability to perform high-level mathematical computations with extreme accuracy.
• Ability to communicate confidential patient/donor test results effectively and clearly to physicians, nursing personnel, or other appropriate personnel.
• Professional appearance and behavior
• Strong interpersonal, organizational, and customer service skills
• Team player attitude

Primary Responsibilities:

• Oversee all day-to-day activities within the CT and Cord Blood processing laboratories and ensure they are carried out in strict adherence to all facility policies and procedures and current regulatory guidelines and standards, including AABB, FACT, FDA, NMDP, etc.
• Schedule CT & Cord Blood laboratory staff to provide adequate coverage for the daily workload.
• Ensure all necessary steps are performed for testing, processing, cryopreservation, and shipping of HPC-Apheresis, HPC-Marrow, HPC-Cord Blood, and Peripheral Mononuclear Cells (MNCs) for infusion.
• Create, develop and write new Cell Therapy Lab processes, policies and procedures as needed.
• Annually and as needed, review and update all Cell Therapy Lab documents to remain in full compliance with current regulatory standards.
• Write Cord Blood & CT validation plans, ensure validation procedures are performed as appropriate and write validation performance summaries.
• Oversee hiring and training of new staff.
• Supervise, train, and review training and competency assessment.
• Participate in annual competency testing and direct observation of cellular therapy procedures. NOTE: Direct observation may occur more frequently (i.e. during internal and external assessments, as requested by supervisor, etc.).
• Schedule and conduct staff performance reviews.
• Ensure Cell Therapy Laboratory proficiency testing is accurate, performed, and reported according to schedule.
• Actively participate in internal and external assessments.
• Perform root cause analysis and develop a corrective action plan as needed.
• Review CT & Cord Blood lab worksheets for accuracy and completeness.
• Review and file patient and donor records as appropriate.
• Perform and ensure Cell Therapy Laboratory equipment quality control and preventative maintenance are performed as defined for each piece of equipment.
• Manage critical equipment in iMaint and prepare work orders as appropriate.
• Perform calibration on equipment or send for calibration as needed.
• Maintain Cord Blood Processing, CT Processing, and CT testing laboratories in a clean and orderly manner.
• Maintain current knowledge of Cellular Therapy and Cord Blood regulations and standards - AABB, FACT, FDA, NMDP, etc.
• Obtain a minimum of 12 hours of continuing education related to Cell Therapy per year.
• Assist technologists with bench work and calls.
• Work with the Medical Directors and Cell Therapy Quality Officer to ensure functions of the processing lab continue with good workflow and communication.
• Communicate directly with the Medical Director and/or designee and assist in duties as needed.
• Explore initiatives for cost savings.
• Complete financial projections and budget reporting