SPVR CELL THERAPY at H. Lee Moffitt Cancer Center – Tampa, Florida

Position Highlights:

• Opportunity to join a NCI designated comprehensive cancer center in production of blood and marrow transplants including novel cellular therapy treatments for cancer patients
• Participation in blood and marrow transplants along with innovative adoptive cellular therapy treatments
• Involvement in the rapidly growing multiple clinical trials within the cell therapy area.

The Ideal Candidate

• Familiarity with human cells including: hematopoietic, mesenchymal, primary tumor cells and/or cell lines
• Aseptic cell processing methodology
• Basic knowledge of hematology, immunology, blood banking and microbiology, Cell culture methods, Flow cytometric assay methods, PCR methods, sterility testing, cell counting, ELISA/ELLA
• Laboratory Information System operation and validation
• Accreditation and regulatory requirements
• Working knowledge of laboratory quality
• The successful candidate will be a strong communicator, engaged, and will work closely with members of the Cell Therapy Team.
• Exhibit interest and excitement in participating in the production of cellular products
• Proficiency in adherence to the applicable regulations and standards (e.g., GMP, GTP, AABB, FACT, CAP, JCO
• Possession of State of Florida Medical Technologist License in the areas of serology and hematology.

Key Responsibilities:

• Perform technologist duties and oversee daily operations of the cell processing laboratory, ensuring efficient workflow and compliance.
• Provide technical supervision of laboratory processes, testing procedures, and ensure proper documentation and record-keeping.
• Manage and supervise technical and support personnel, including conducting performance reviews, counseling, interviewing, hiring, and disciplinary actions in a timely and fair manner.
• Maintain up-to-date knowledge of relevant technical procedures, policies, and regulatory standards, including FDA Good Manufacturing Practices (GMP), Good Tissue Practice (GTP), and accreditation requirements such as FACT, CAP, CLIA, and AABB.
• Collaborate with Facility Manager, Quality Assurance Unit, and Director to ensure compliance and quality assurance activities are accurately performed.
• Serve as a technical resource to staff during and outside of working hours when needed.
• Provide technical orientation, training, and instruction for new personnel, ensuring competency and maintaining current training and competency records.
• Assist in developing and implementing training programs, identifying areas for improvement at individual and program levels.
• Write, revise, and review technical standard operating procedures or batch process records (SOPs or BPRs) and policies to ensure accuracy and completeness.
• Manage daily laboratory activities including scheduling, workflow distribution, completion of procedures, and timely documentation and reporting.
• Adapt and adjust workflow in response to changes during shifts to maintain operational efficiency.
• Demonstrate extensive knowledge of technical procedures and independently troubleshoot issues, identify problems, propose solutions, and implement corrective actions.
• Identify and lead quality and process improvement projects to enhance laboratory performance.
• Ensure all applicable safety standards are followed within the department.
• Collaborate with management on budgeting, staffing, and resource planning.
• Identify and escalate issues related to the physical facility or laboratory equipment.

Credentials and Qualifications:

• Bachelor’s Degree in relevant Biological Science or Medical Technology.
• Minimum of 3 years of relevant experience in a GMP Laboratory producing cell-based therapeutics or a minimum of 3 years of experience as a Medical or Laboratory Technologist (with experience in the context of quality control, and/or assay development or validation)
• 20/20 near vision (corrected or uncorrected).
• Evidence of continued education, preferred within the field of immunology
• Knowledge of GMP/GTP regulations for pharmaceutical or biologics manufacturers and/or blood bank establishments.
• Experience with patient/product safety, performance improvement, project management and working with medical staff.

• Demonstrated ability to work independently to achieve expected outcomes.
• Lead efforts within assigned section to seek and take advantage of opportunities in daily operations to improve processes, generate revenue and/or eliminate wasteful spending as part of the Cancer Center’s Strategic Margin Management initiatives.
• Contributes to Cell Therapy Core to development and implementation cost recovery efforts.
• Work collaboratively across the Cell Therapy Core in generating project budgets to support new protocols, investigator grants, contracts and clinical trials