THIS IS AN IN-OFFICE POSITION. ONLY QUALIFIED CANDIDATES APPLY.

Gift of Life has been curing blood cancer and other life-threatening diseases for 30 years. We do this by providing healthy volunteer donors that patients need for marrow and blood stem cell transplants.

We are a group of 70 skilled professionals with a passion for saving lives. Our goal is an audacious one: to ensure that every patient receives the cellular therapy they need when they need it. That’s why we are so innovative. Twenty years ago, we were the first to recruit donors using cheek swabs. We developed the first online donor recruitment website and then the first mobile app. And we are the first in the world to feature a vertically integrated cell therapy supply chain, with the registry, donor center, stem cell collection center, and cellular therapy laboratory all under one roof in our modern, high tech 32,000 square foot headquarters. We love what we do. So if you are passionate, audacious, and committed to saving lives, check us out!

Job Title

Cell Therapy Operations Supervisor

Department

Cellular Therapy Laboratory and BioBank

Education

Master’s degree in biological science. A minimum of 3 years of supervisory experience in a complex laboratory setting.

Summary Statement

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

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 adhere 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 the 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 Batch Records, SOPs, and on-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

• 5+ 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, aseptic processing, and cell therapy
• Exemplary communication skills
• Mature judgment with strong decision-making skills
• Strong work ethic with the ability to take the 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 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 / Working Conditions

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 more than 20 pounds. Travel may also be required. Exposure to infectious diseases, hazardous chemicals 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 them to meet the organization's ongoing needs.

Benefits

Gift of Life Marrow Registry is pleased to offer benefits to eligible employees that include:

• Group Medical Insurance
• Dental and Vision Insurance
• Disability
• Life Insurance
• Paid Time Off, Holidays
• 401(k) Plan with Company Match after the first year

Gift of Life's facility is new and well appointed, offering an employee café with televisions, three coffee bars, height adjustable workstations and ergonomic seating, an outside courtyard with fountains, picnic tables, and a tree-shaded parking lot, and a wellness room. We are located near numerous restaurants and grocery stores.

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

COVID-19 considerations:
Masks are required to be worn at all times, temperature checked daily, and sanitization stations throughout the office.

Ability to commute/relocate:

• Boca Raton, FL 33487: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have a minimum of 5 years in a cGMP environment?
• Do you have a Master's degree in Biological Science?

Education:

• Bachelor's (Required)

Experience:

• bio-industry: 5 years (Required)
• Management: 3 years (Required)
• cGMP environment: 5 years (Required)
• upervisory experience in a complex laboratory setting: 3 years (Required)

Work Location: In person

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