Analytical Radiochemist, Quality Control

TerraPower.•Everett, WA

1d•Onsite

About The Position

The TerraPower Isotopes® (TPI™) division has been established to pursue medical isotopes development--advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. TerraPower currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments. The TerraPower Isotopes program is an integral part of the Washington State based TerraPower team, a company working to raise living standards globally. In 2006, the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. TerraPower’s mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field. TPI is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine. TerraPower is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. Position Summary TerraPower Isotopes is seeking an Analytical Radiochemist to support the analytical characterization, quality control testing, and release of radioisotopes and radiopharmaceutical precursors produced at the Everett facility. This role is central to ensuring the analytical reliability and regulatory compliance of isotope production operations. The Analytical Radiochemist will contribute to the development, validation, transfer, and execution of analytical methods supporting both process characterization and GMP manufacturing. The successful candidate will work within a multidisciplinary team of scientists, engineers, and quality professionals to generate high-quality analytical data that enables safe production, regulatory compliance, and timely product release. This position is well suited for analytical scientists who enjoy solving complex measurement challenges, improving analytical robustness, and operating in a mission-driven environment where rigorous science directly supports medical innovation.

Requirements

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 relevant to analytical testing or isotope production.
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.

Nice To Haves

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 for data management and records retention.
Ability to interpret regulatory requirements, codes, and standards and incorporate them into laboratory procedures and documentation.

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 a 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 other laboratory documentation supporting radioisotope production.
Develop and implement analytical procedures, documentation, and laboratory forms relevant to isotope production and quality control activities.
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.
Support training and mentoring of laboratory staff.
Support management of laboratory chemical inventories, including ordering, evaluation of storage conditions, labeling, and compliant disposal of chemicals.
Maintain organized and safe laboratory environments, including analytical laboratories and radiological controlled areas.
Support, maintain, or lead integration of analytical instrument reporting capabilities with the Laboratory Information Management System (LIMS).