Cell Therapy Processing Specialist II-Human Applications Lab

About the role

The Human Applications Cellular Therapy Laboratory (HAL) supports the Departments of Bone Marrow Transplantation and Cellular Therapy, and Oncology (Neuro-Oncology and Solid Tumor services) by providing products for patients enrolled in investigator-initiated clinical research protocols. The laboratory is actively engaged with many treatment protocols for cancer and genetic diseases, using primary hematopoietic graft products and genetically modified products for sickle cell disease and CAR T-Cell therapy applications. The HAL is composed of two sections: the Quality Control Section providing product analysis by flow cytometry, product quality testing for sterility, and facility environmental monitoring; and the Cell Therapy Processing Section providing cellular therapy product processing in accordance with good tissue practices and good manufacturing practices, product infusions, and product transfer/shipping.

The Cell Processing Specialist II will be responsible for performing complex, highly specialized technical processing procedures, using aseptic technique and maintaining attention to detail for technical and documentation functions. Cellular therapy laboratory experience, flexibility, teamwork, and good communication skills are essential for this position.

Responsibilities

• Performs cellular therapy processing and cryopreservation procedures in accordance with the Standard Operating Procedures in an accurate and timely manner.
• Participates in maintaining accurate documentation in compliance with FDA’s Good Tissue Practices and Good Manufacturing Practices regulations, as well as standards including but not limited to FACT, CAP and AABB.
• Demonstrates workflow organizational skills and good time management skills.
• Reviews processing records for acceptability, accuracy, and completeness.
• Serves as a resource for documentation related questions and applications in accordance with regulations, SOPs, and established laboratory practices.
• Performs reagent and instrument quality control at the appropriate intervals, interprets and correctly records results.
• Participates in equipment qualification and procedure validation applications.
• Serves as a resource for troubleshooting guidelines.
• Becomes familiar with the processing and dose requirements for all transplant related protocols at SJCRH.
• Assists in maintaining coverage in the laboratory to promote optimal workflow.

Skills

• Excellent verbal and written communication skills.
• Flexibility and adaptability with changing schedules and priorities.
• Ability to work in teams and effectively communicate transitions in work processes.
• Excellent mathematical skill, analytical skill, and technical dexterity.
• Ability to function in a clean-room environment and sustain prolonged physical exertion.
• Ability to move and connect liquid nitrogen (LN2) source tanks used for cell cryopreservation.
• Ability to remove internal components of biosafety cabinets for monthly cleaning.

Requirements

• Education: Bachelor’s degree (e.g., medical technology/medical laboratory sciences or biological, chemical or physical science) required. Master's degree preferred.
• Experience: 4+ years of relevant experience required. Master's degree with 2+ years of relevant experience accepted as an exception.
• Prior experience with clinical lab techniques and procedures.
• Experience engaging with all levels of hospital personnel and physicians to coordinate section activities and exchange technical/sensitive information.
• Proven performance in an earlier role.
• Certification: Certification as a Medical Technologist by ASCP, NCA, or AMT preferred.

Pay

A reasonable estimate of the current salary range is $31.50 - $55.00 per hour for the role of Cell Therapy Processing Specialist II-Human Applications Lab. This is an estimate offered in good faith; a specific salary offer takes into account factors including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs.

Schedule

Routine schedule is Monday through Friday day shift with flexibility to evening shift due to the variable nature of incoming cellular products and associated procedures. Rotates on-call coverage approximately once every six weeks.