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 novel specific biomarker. The Research Scientist - Radiochemistry & Imaging will conduct research and be responsible for the planning and execution of research projects involving radiochemistry for the Neurotheranostics Program. The individual will participate in development and clinical production of PET radiotracers; manage the dispensing, compounding and quality control of radiotracers; assist the Program Heads 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.
Essential Functions
Radioisotope Handling and Dispensing
Synthesizes non-radioactive chemical precursors from which radiopharmaceuticals are to be manufactured.
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.
Develops procedures for in vitro binding assay of new radiotracers; works on animal injections and biodistribution studies involving radioactive agents.
Applies principles and practices of pharmacy and radiochemistry to prepare and dispenses unit doses of radioactive pharmaceuticals used for patient study.
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.
Documentation and Record Keeping
Maintains compliance with the established regulations for radioactive and other hazardous operation, including, but not limited to daily check, weekly, and monthly quality assurance, radiation safety, procedures, US Pharmacopeia, Food and Drug Administration (FDA), 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 subsequent plan of action.
Radiochemistry Safety
Monitors assigned area for radiation safety such as wipe test, dose exposure survey; ensures that radiopharmaceutical personnel wear appropriate personnel protective equipment (PPE) when working in hazardous controlled areas.
Ensures that the cGMP room, radiochemistry room, and PET imaging room are clean, organized, and safe for personnel; limits access only to those by qualified/required personnel.
Works to ensure minimal radiation exposure and compliance with the \"As Low as Reasonably Achievable\" (ALARA) principle.
Responsible for ensuring radiation detection equipment is worn by personnel working in the reactive material involved areas.
Performs/documents daily dosimeter checks; ensures radioactive/biohazard waste segregation and disposal and completion of related documentation; ensures appropriate storage and handling of radiation detecting equipment.
Perform analyses, including PET MR imaging analysis and statistical analysis of data.
Plan and execute a wide range of projects in basic and clinical research. Excellent practical skills and good understanding in 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 short lived 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.
Formal Education, and Training
Post Graduate degree required (PhD, MD, etc.) with history of publication in first-tier refereed journals, history of funded and successfully completed grants from federal and/or private funding agencies; academic appointment at affiliated institution(s).
Job Related Experience
At least two years of experience as a radiochemist. The candidate is expected to show strong research track record and apply radiotracer methodology to basic science and clinical investigation to study of pediatric related basic science and diseases/disorders.
Preferred: Familiarity with imaging analysis software: Vivoquant, MatLab