H. Lee Moffitt Cancer and Research Institute is a modern facility in Tampa, Florida.  We strive to be the leader in understanding the complexity of cancer through team science and applying those insights for human benefits.  Be part of the cure by joining Moffitt's team of over 800 research faculty scientists, career staff scientists, postdocs, graduate students, and support staff dedicated to cancer research.

The TIL Lab Operations Director serves as a scientific and technical resource for Cancer Center investigators and external industry collaborators requiring expertise in the experimental design of new TIL-driven cellular therapies. Specifically, the Director would oversee development, isolation, and expansion methods for TIL in support of pre-clinical researchers and ultimately clinical trials. The Director works closely with Cell Therapies Facility for the production of large-scale GMP-grade TIL products in support of clinical trials, while working closely the Cell Therapies Facility.

Position Highlights & Responsibilities:

• TIL Development Activities: Lead, manage and supervise research projects that investigate TIL and focus on future strategies for enhancing the potency of TIL used for adoptive T cell therapy.
• Personnel Management: Leads, mentors, coaches highly trained staff, high performance cellular therapy
• department to meet Facility commitments.
• Technical & Operational Oversight of Commercial Opportunities: Works in collaboration with MCC Cell Therapies Leadership to identify and assess commercial opportunities and makes recommendations to the MCC Senior Leadership
• Planning and Resource Management: Ensures that assigned research projects are properly delegated, planned, tracked, prioritized and sourced to maximize effective and efficient execution.
• Financial Responsibilities: Provides leadership, strategic oversight, resource management, and organizational framework to ensure meeting financial goals related to forecasting, project budgets in support of achievement of internal and external deliverable goals.

The Ideal Candidate will have:

• 5 + years of experience in cell and gene therapy manufacturing, research and development
• 3 years in oversight/supervisory role & responsibilities in an academic or commercial laboratory
• Broad understanding of laboratory and regulatory requirements in cellular therapy related research, including QA requirements.
• Working knowledge of the clinical research environment.
• Working knowledge of IRB and Regulatory approvals.
• Working knowledge of Materials and Technology Transfer including transitioning of research techniques into cGMP production methods and start-up of existing or new processes at internal and external manufacturing facilities.
• Working knowledge of FDA regulations governing clinical research, Good Clinical Practices (GCP), and OHRP regulations.
• Excellent written and verbal communication skills.
• Working 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; Laboratory Information System operation and validation new assay development; Accreditation and regulatory requirements.

Preferred qualifications:

• Knowledge and experience in the operation and of an academic or commercial cell processing and manufacturing laboratory or facility, including demonstrated education and experience in areas of hematopoietic progenitor cell transplantation principles and practices, TIL expansion and functional testing, regulation and accreditation requirements for cell processing facilities.
• Experience in developing new technologies for translation of cellular therapies in close collaboration with Cancer Center investigators. Specifically, providing end-to-end support through all stages of clinical trials research, including but not limited to collaboration on experimental design during pre-clinical planning and post-therapy immune monitoring. Relatedly, experience related to technology transfer, data analysis and presentation of data.
• Experience with project management software and maintenance and development of electronic databases strongly preferred.
• Demonstrated experience in successfully managing validation programs in support of GMP operations.
• Knowledge/Experience in research interactions with cell therapies-based companies.
• Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally, and developing strong technical talent.
• Hands-on knowledge of cell manipulation/cryopreservation, bone marrow transplant, cord, blood/expansion, in vitro cell culture, clinical trial processes, etc. are a plus.
• Preferred to have familiarity with assays for endotoxin, mycoplasma, Gram Stains, ELISA, magnetic bead cell separation. 

Educational requirements:

• PhD in Medical Technology/Biological Sciences, Cellular Therapies, Immunology, Bioengineering, Molecular Biology, Chemical Engineering or related field required.