The National Cancer Institute’s (NCI) Center for Cancer Research (CCR) seeks a Nuclear Pharmacist
to support the development, production, and clinical translation of novel positron emission
tomography (PET) radiotracers and radionuclide therapeutics within the Molecular Imaging Branch.
This position plays a key role in advancing investigational radiopharmaceuticals from laboratory
discovery through clinical-grade production for use in first-in-human and early-phase clinical
trials at the NIH Clinical Center.

The successful candidate will work in a highly collaborative translational research environment
alongside radiochemists, imaging scientists, physicians, and clinical investigators to develop and
implement compliant radiopharmaceutical production systems that support innovative cancer imaging
and therapeutic studies.

The incumbent will perform a variety of duties, including:
• Develop, optimize, and implement radiopharmaceutical production processes for PET
tracers and therapeutic radionuclides — including processes involving biohazardous components — and
conduct strategic process validation activities adapted to the unique challenges of short-lived
radioactive investigational agents.
• Develop, optimize and implement non-radioactive production processes for filling of sterile
pathways involved in hyperpolarized Carbon-13 MRI studies. Will also be responsible for release of
the final product for injection into patients.
• Perform and oversee production and quality control assessments of clinical-grade
radiopharmaceutical products prior to patient administration, including review and approval of
batch production records.
• Establish, maintain, and continuously improve the quality assurance system supporting compliant
production of investigational radiopharmaceuticals and PET tracers, including tracking quality
indicators, conducting internal audits, and executing change control procedures to ensure ongoing
regulatory compliance.
• Develop and administer standardized training and qualification programs for aseptic production
operators and technical staff involved in radiopharmaceutical manufacturing.
• Oversee validation, calibration, and qualification of critical equipment, and coordinate
procurement and management of radionuclides, precursor materials, and specialized reagents in
accordance with applicable regulatory requirements and institutional policies.
• Assess risks associated with radiopharmaceutical production, identify mitigation strategies, and
lead investigations of production deviations using root-cause analysis and
corrective and preventive action (CAPA) processes.
• Define raw material, intermediate, and final product specifications, including pedigree
requirements, analytical methods, and validation strategies appropriate to the stage of product
development.
• Ensure that radiopharmaceutical production staff, facilities, equipment, materials, and vendors
meet all applicable regulatory and institutional requirements, including radiation safety
regulations governing the handling, storage, and disposal of radioactive materials.
• Contribute to regulatory documentation supporting Investigational New Drug (IND) applications, with
particular focus on Chemistry, Manufacturing, and Controls (CMC) sections.
• Collaborate closely with scientific and clinical teams to translate novel radiopharmaceutical
agents from preclinical development into clinical trials.
• Provide technical leadership and mentorship to pharmacists, technologists, and trainees involved in
radiopharmaceutical production and quality systems.

CCR, the intramural research program of the NCI in Bethesda, MD, provides a premier environment for translational and clinical cancer research. CCR investigators have access to the NIH Clinical Center, the nation’s largest hospital devoted exclusively to clinical research – as well as extensive opportunities for interdisciplinary collaboration and exceptional clinical and research support services. CCR investigators lead more than 300 clinical trials and open over 50 new studies annually, advancing cutting-edge laboratory and patient-centered research. For an overview of CCR, please visit http://ccr.cancer.gov/.

This position offers the opportunity to pursue innovative, high-impact research in a collaborative environment working in a newly established cGMP facility designed for radiopharmaceutical production. Investigators benefit from strong institutional resources for publications, scientific presentation, and conference travel. The role also offers limited telework flexibility and a predictable and supportive work schedule that promotes work-life balance within a dynamic and mission-driven research program.