The Neurotheranostics Program at Nemours Children's Health System is a multi-specialty close-collaborative initiative aiming to advance diagnostics and therapeutics of various pediatric neurological, oncological, and neuropsychiatric disorders through the design and synthesis of novel PET radioligands as specific biomarkers. The Postdoctoral Research Fellow will be responsible for the planning and execution of research projects involving biomarker identification and radiochemistry development for the Neurotheranostics Program. The Neurotheranostics team collaborates with the departments of Research, Radiology, Neurology, and Oncology at Nemours, and with external partner institutions.
The successful candidate will participate in pre-clinical radiotracer development and evaluation, and clinical translation of PET radiotracers; manage the dispensing, compounding, and quality control of radiotracers; support the Program/Lab Head in formulating and conducting various research projects that fall within the scope of approved protocols; assist in protocol development and obtaining regulatory approvals; seek funding for projects; ensure safe and reliable unit dose dispensing of both investigational radiotracer imaging agents and pre-clinical research radiotracers in compliance with Food and Drug Administration, Nuclear Regulatory Commission, United States Pharmacopeia, and local state rules and regulations.
Qualifications:
Post-graduate degree (PhD, MD) History of publication in first-tier refereed journals; History of research track; history of funded and successfully completed grants from federal and/or private funding agencies; academic appointment at affiliated institution(s)
Experience as a radiochemist is preferred. The candidate is expected to show a strong research track record and apply radiotracer methodology to basic science and clinical investigation to study pediatric-related basic science and diseases/disorders.
Essential Functions:
Radioisotope Handling and Dispensing
Synthesizes non-radioactive chemical precursors from which radiopharmaceuticals are to be manufactured. Develop and optimize radiolabeling procedures using automatic synthesizers.
Develops and implements quality control procedures for new PET radiopharmaceuticals for increased efficiency and accuracy.
Prepares documentation for new PET radiopharmaceuticals in compliance with department procedures and regulatory agencies requirements.
Works collaboratively with physician-sponsor(s), various researchers, and head radiochemist to produce and provide cGMP-grade novel PET tracers for clinical and research studies when needed.
New radiotracer development and evaluation
Identifies and validates novel biomarkers related to pediatric disorders in clinical or rodent samples through qPCR, immunohistostaining, western blot analysis, flow cytometry, etc.
Conducts test-retest studies and statistical analyses to correlate biomarker analysis with in vitro imaging results and validate the findings in in vivo animal models.
Documentation and Record Keeping
Maintains compliance with the established regulations for radioactive and other hazardous operations, including, but not limited to, daily checks, weekly and monthly quality assurance, radiation safety, procedures, US Pharmacopeia, Food and Drug Administration (FDA), and Nuclear Regulatory Commission (NRC).
Documents and participates in chemical inventory and waste disposal, Corrective Action Preventive Action (CAPA); assists with Out of Specification (OOS) event investigations and proposes a subsequent plan of action.
Works to ensure minimal radiation exposure and compliance with the \"As Low as Reasonably Achievable\" (ALARA) principle.
Plan and execute a wide range of projects in basic and clinical research. Excellent practical skills and a good understanding of organic chemistry, radiotracer development, and associated analytic techniques. Knowledgeable in current Good Manufacturing Practices (cGMP) for PET radiotracer production and ALARA radiation safety procedures are strictly required. Previous demonstrated successful experience with F-18 radiochemistry and animal handling is highly desirable.
Independently perform experiments using a range of experimental techniques, including radiochemistry automation modules, HPLC, GC, endotoxin test, sterility test, binding assay, small animal PET scans, etc.
Prepare abstracts for presentation, manuscripts for publication, and actively seek intramural and extramural funding.
Supervise study execution and completion.
Participate in departmental and hospital programs for quality assessment and improvement, including identifying, recommending, and implementing opportunities to improve services.
Assist in protocol development and seeking/obtaining funding.