The Human Applications (Cell Therapy) Laboratory 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 supports many treatment trials 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 Cell Therapy Lab 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.
Contributing to our mission of finding cures and saving children, we are looking for a dedicated professional to join the Cell Therapy Processing Section as a Specialist I. The Cell Therapy Processing Specialist I will be responsible for performing complex, highly specialized technical processing procedures, using aseptic technique and maintaining attention to detail for technical and documentation functions. Due to the nature of cell therapy work (patient needs and protocol requirements) flexibility, teamwork, and good communication skills are essential for this position.
Routine Schedule is Monday through Friday evening shift (12:00 - 20:30) with flexibility to adjust due to the variable nature of incoming cellular products and associated procedures.(Rotates on-call coverage approximately once every six weeks.)

Responsibilities

• Execute routine technical processing procedures (e.g., product characterization, graft manipulation, cryopreservation and storage) in accordance with the Standard Operating Procedures with guidance where required.
• Perform assigned quality functions including documentation for good documentation practices and compliance with cGMP, cGTP, and laboratory quality control practices.
• Conduct appropriate documentation review, data capture, and reporting (e.g., processing record documentation review and follow-up; protocol-specific data capture and dissemination).
• Assist in set-up, preventive maintenance, and troubleshooting activities for equipment within lab under guidance.
• Participate in ongoing lab inventory planning, monitoring, and management

Additionally, the selected candidate will have the following skills and abilities:

• 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. Liquid nitrogen tanks are used for cell cryopreservation frequently and biosafety cabinets are cleaned monthly

MINIMUM EDUCATION AND/OR TRAINING:

• Bachelor’s degree (e.g., medical technology or biological, chemical or physical science) required.
• Master’s degree preferred

MINIMUM EXPERIENCE:

• Prior experience with clinical lab techniques and procedures preferred.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to stand; walk; sit; kneel, use hands to finger, handle, or feel; and talk or hear.
• The employee must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, depth perception and the ability to adjust focus.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.
• An essential function of the job is to be able to comply with all applicable federal, state and local safety and health regulations that would apply to this job.
• The employee must move about the work space to access work surface and shelves, cabinets, drawers, and equipment that are at, below or above the work surface.
• Nothing in this job description limits management’s right to assign or reassign duties and responsibilities to this job at any time as business needs dictate. This job description reflects management’s assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned. The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor is it intended to be an all-inclusive list of the skills and abilities required to do the job.

• Execute routine technical processing procedures (e.g., product characterization, graft manipulation, cryopreservation and storage) in accordance with the Standard Operating Procedures with guidance where required.
• Perform assigned quality functions including documentation for good documentation practices and compliance with cGMP, cGTP, and laboratory quality control practices.
• Conduct appropriate documentation review, data capture, and reporting (e.g., processing record documentation review and follow-up; protocol-specific data capture and dissemination).
• Assist in set-up, preventive maintenance, and troubleshooting activities for equipment within lab under guidance.
• Participate in ongoing lab inventory planning, monitoring, and managemen