Analytical Radiochemist, Quality Control

Position Summary

The TerraPower Isotopes program 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.

Key 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).

Required 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 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.

Preferred Qualifications

• 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.

Key Competencies

• Scientific Rigor and Attention to Detail
• Problem Solving and Analytical Thinking
• Technical Communication
• Operational Discipline
• Team Collaboration

Job Functions

• Sitting for extended periods
• Bending/stooping
• Grasping/gripping
• Fine motor control (hands)

Benefits

• Competitive Compensation
• Medical and Wellness Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
• Relocation Assistance
• Professional and Educational Support Opportunities