WE ARE LOOKING FOR QUALIFIED CANDIDATES FOR OUR BOCA RATON, FLORIDA LOCATION ONLY. THIS IS NOT A REMOTE POSITION.

Our Mission

Gift of Life Marrow Registry cures blood cancer through cellular therapy. We believe every person battling blood cancer deserves a second chance at life — and we are determined to make it happen. We are singularly passionate about engaging the public to help us get everyone involved in curing blood cancer, whether as a donor, a volunteer, or a financial supporter. It all begins with one remarkable person, one life-changing swab, and one huge win — finding a match and a cure.

Department

Cellular Therapy Laboratory and BioBank

Summary

The Cell Therapy Operations Supervisor is part of the Gift of Life Center for Cell and Gene Therapy team that supports the production of cell therapy products. The Cell Therapy Operations Supervisor is a key position, responsible for oversight of the development and manufacturing of cell therapy products including Hematopoietic Stem Cells (HSCs), T-Cells and Mononuclear Cells (MNCs) in a cleanroom (ISO 7) environment. The position collaborates with other department managers/supervisors and reports to the Scientific Director.

The Supervisor is responsible for all cell processing related tasks to produce cell-based products including but not limited to specialized customer manufacturing, biobank of off-the shelf products, developing relevant SOPs, contributing to process validations, and continuous improvement of the Gift of Life scientific platform to support a growing cell and gene therapy center.

We are seeking a highly motivated individual with initiative, expertise in cell therapy, leadership and team work experience. The work requires mature judgment, decision-making capability and outstanding communication skills. Effective cross-functional collaboration with other departments, such as QA department, is necessary to the position. Flexibility in scheduling is required due to manufacturing needs.

Employment Type

Full-time

Education

Master's degree in biological science. A minimum of three (3) years of supervisory experience in a complex laboratory setting. 

Responsibilities

• Supervise personnel to execute cell processing of PBSCs and MNCs, cell isolation using Prodigy (T cells and CD34+ cells in an ISO 7 cleanroom setting) and flow cytometry analysis.
• Provide guidance and training to staff in alignment with internal standard operating procedures, and FDA cGMP requirements.
• Plan and execute daily work activities to meet production demands.
• Monitor cell processing staff to ensure they are adhering to regulatory and operational procedures.
• Address and resolve technical or procedural problems and advise scientists on the proper course of action.
• Perform scientist duties, as needed.
• Proactively identify and assess operational risks and communicate issues to the Scientific Director.
• Extensive experience in cell processing and expansion, cell counting, cryopreservation, and intermediate formulations.
• Experience in cell therapy, such as application of stem cells and CAR-T.
• Proficiency in ISO-7 cleanroom manufacturing and comprehensive knowledge of Good Manufacturing Practices (GMP).
• Authoring, revising, and reviewing of Batch Records, SOPs, and on the job-training documents.
• Enter and review variances and execute corrective and preventative actions in collaboration with the QA Department.
• Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
• Assist in the development of new lab processes and the selection of new laboratory equipment and materials.
• Oversight of Cell Therapy processing and laboratory operations.
• Ensure cell processing staff update chart documentation after cell processing or isolation.
• Lead validations and qualifications for equipment, materials and processes.
• Orient, train, and mentor cell processing personnel.
• Participates in department meetings and educational programs.
• Other duties as assigned.

Knowledge, Skills, and Experience

• Five+ years of bio-industry experience with a minimum of 5 years in a cGMP environment and 3+ years of management experience.
• Strong understanding of compliance, asepctic processing, and cell therapy.
• Exemplary communication skills
• Mature judgment with strong decision-making skills
• Strong work ethic with the ability to take initiative and multi-task
• Strong leadership skills
• Ability to alternate between being a leader and a team player
• Ability to collaborate, communicate and be accountable
• Comfortable working and leading in a changing and fast-paced environment
• Ability to identify and communicate priorities
• Ability to deal with complex problems and propose creative solutions
• Desire to continually learn and to teach those around you
• Flexibility in scheduling

Physical Demands

This position requires walking, standing, stooping, lifting, and using tools requiring high dexterity. Working in a CNC and ISO 7 cleanroom area. Occasional lifting of objects weighing in excess of 20 pounds. Travel may also be required. Exposure to infectious diseases, hazardous chemical and materials, needle sticks, blood and body fluids.

This job description is not intended to be all-inclusive. Duties and/or responsibilities may be added or deleted as management requires to meet the ongoing needs of the organization.

APPLY NOW 

Please attach your resume in an email to jlizondro@giftoflife.org.