Analytical Radiochemist, Quality Control

TerraPower·Everett, WA, USA·Posted today

Nuclear industryUS only

About this role

TerraPower Isotopes seeks an Analytical Radiochemist to support quality control testing and release of radioisotopes and radiopharmaceutical precursors at the Everett facility. You'll develop and execute analytical methods, ensure regulatory compliance, and generate high-quality data enabling safe production and timely product release in a mission-driven medical isotope environment.

Responsibilities

—Perform analytical testing supporting in-process monitoring, stability studies, and final product batch release
—Develop, optimize, and execute analytical methods for radioisotopes and radiopharmaceutical precursors
—Participate in method validation, qualification, transfer, and verification activities following ICH Q2 and USP guidance
—Operate analytical techniques including gamma spectroscopy, alpha spectroscopy, ICP-MS/ICP-QQQ-MS, ICP-OES, radio TLC scanning, and liquid scintillation counting
—Perform radioactivity calculations including decay corrections and isotopic equilibrium assessments
—Calibrate and troubleshoot instrumentation such as HPGe detectors, ICP-MS/OES, alpha spectroscopy systems, and LSC systems
—Generate and review analytical data according to ALCOA+ data integrity principles
—Utilize LIMS compliant with 21 CFR Part 11 to manage analytical data and laboratory records
—Support investigations including OOS, OOT, and laboratory deviations; contribute to root cause analysis and CAPA implementation
—Author and maintain SOPs, analytical methods, validation documents, investigation reports, and laboratory documentation
—Prepare analytical standards, reagents, and reference materials
—Conduct laboratory work within radiological controlled areas and glovebox environments
—Collaborate with QA, Manufacturing, Radiochemistry, and Engineering teams
—Identify opportunities to improve analytical reliability and laboratory efficiency

Qualifications

—Bachelor's degree or higher in Chemistry, Radiochemistry, or related scientific discipline
—3+ years of hands-on experience performing analytical or radioanalytical measurements
—Experience with wet chemistry and analytical sample preparation
—Experience operating, calibrating, or troubleshooting analytical instrumentation
—Experience developing and implementing analytical procedures, documentation, and laboratory records
—Demonstrated ability to independently plan, design, execute, and analyze complex experiments and analytical activities while meeting project or production timelines
—Ability to work in a regulated laboratory environment supporting pharmaceutical or radiopharmaceutical production

Desired

—Experience with analytical method development, validation, qualification, or transfer
—Experience in laboratories operating under cGMP (21 CFR 210/211) or GLP
—Familiarity with radiochemical analysis and isotope characterization
—Experience working in radiological laboratories or glovebox environments
—Experience using laboratory information management systems (LIMS) compliant with 21 CFR Part 11
—Experience using laboratory quality support software or electronic systems