PROGRAM DESCRIPTION
The Frederick National Laboratory for Cancer Research (FNL) is a Federally Funded Research and Development Center sponsored by the National Cancer Institute (NCI) and operated by the prime contractor Leidos Biomedical Research, Inc. FNL is responsible for pursuing a unique mission in translational and applied biomedical research that is unsuitable for academia, the pharmaceutical industry, or other federal contractors.
The selected candidate will join the NCI Division of Cancer Treatment and Diagnosis (DCTD) support group located at the NCI-Frederick campus. This program supports the NCI DCTD by developing and providing radiopharmaceuticals for clinical trials and preclinical studies. Activities include production and/or procurement of investigational and experimental radiopharmaceuticals; contributing to the advanced development of the DCTD- and non-DCTD-sponsored investigational radiopharmaceuticals; supporting clinical trials; and providing nuclear medicine sites with access to DCTD radiopharmaceuticals.
The ideal candidate is an experienced chemist who enjoys working on multiple high-impact projects in both the developmental and cGMP-compliant manufacturing arenas and is highly motivated to contribute to the fight against cancer.
KEY ROLES/RESPONSIBILITIES
- Produce radiopharmaceuticals in a clean production environment (cGMP or “cGMP-like” depending on the intended use) using either manual or automated methods
- Perform quality control testing of radiopharmaceuticals (e.g., HPLC, GC, TLC, pH, bubble testing, etc.)
- Comply with regulatory requirements for production/QC of radiopharmaceuticals as detailed in FNL Standard Operating Procedures (SOPs)
- Qualify and maintain production/QC equipment
- Contribute to cGMP compliance of facility through activities including cleaning, environmental monitoring, gowning, accurate completion of documentation, creation of exception reports
- Perform aseptic manipulations as required (e.g., sterile vial preparation, dose drawing)
- Receive radioactive material from outside vendor(s)
- Support the development of new laboratory methods including the automation of radiopharmaceutical production methods
- Maintain inventory of lab supplies, as needed, to support laboratory activities
- Preparation of non-radioactive compounds for radiochemistry may be required
- Assist the Laboratory Manager/Supervisor with record keeping and reporting to comply with rules and regulations that apply to the use of radioisotopes
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of Bachelor’s degree in a field related to biomedical research from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of eight (8) years of relevant experience
- Proficient in running HPLC and GC instrumentation
- Excellent verbal and written communication skills
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Experience working in a radiochemistry lab
- Successful experience working in a regulated environment (such as cGMP-like)
- Successful experience with production of radiopharmaceuticals including use of automated radiosynthesizers
- Successful experience with QC of radiopharmaceuticals including development and validation of HPLC and/or GC methods
- Successful experience with aseptic manipulations including completion of media fill qualification
- Successful experience with documentation within a cGMP-complaint quality management system
JOB HAZARDS
- This position is subject to working with or have potential for exposure to animal(s) and/or animal material(s)
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
- This position is subject to working with radioactive material and requires to become an approved radiation worker
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