Job Description

Position Highlights:

Opportunity to join a NCI designated comprehensive cancer center in production of novel cellular therapy treatments for cancer patients Participation in cutting edge adoptive cellular therapy treatments which include the culture and activation of immune cells to return to patients 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 area of serology preferred but not required.

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) 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


Location: H. Lee Moffitt Cancer Center & Research Institute BMT Clinical Lab

Schedule: Full Time, Day Shift, 8:30 to 5:30 with evening and weekend work required.