Quality Control Manager, Isotopes

Overview

Title: Quality Control Manager, Terra Power Isotopes

Location: Everett, Washington

Terra Power Isotopes (TPI™) develops medical isotopes to advance nuclear science for health benefits, supporting radio therapies through the supply of radioisotopes. TPI currently produces actinium-225 for the alpha therapy market and plans to expand.

The Terra Power Isotopes (TPI) business is part of the Washington State based Terra Power team. Terra Power aims to be a world leader in new nuclear technologies and to develop innovators and future leaders in the nuclear field.

TPI seeks highly motivated professionals focused on advanced radiopharmaceutical applications and influencing change within nuclear medicine. Terra Power 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 law. As a federal contractor, Terra Power has an Affirmative Action Plan (AAP) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.

Quality Control Manager – TPI

Terra Power Isotopes (TPI) is seeking an experienced Quality Control Manager to support production of Ac-225 at the Everett manufacturing facility. The Quality Control Manager will oversee testing activities to enable production of Active Pharmaceutical Ingredient (API) starting material in line with pharmaceutical industry requirements and will contribute to the development and performance of analytical methods, procedures, and protocols used for Actinium-225 characterization.

The Quality Control Manager will report to the Director, Quality and will work with a multidisciplinary team including site Quality Systems, Operations, Quality Control, Engineering, R&D, Procurement, and Project Management.

• Manage analytical QC team in delivering Ac-225 batch-release, ensuring robust application of validated radio-analytical methods including alpha spectroscopy, gamma spectroscopy, ICP, radio-TLC and other relevant techniques.
• Accountable for end-to-end QC execution, data integrity, documentation, review, and Certificate of Analysis (CoA) issuance enabling compliant batch disposition.
• Manage development, qualification, and lifecycle management of analytical methods in compliance with ICH Q2 and cGMP expectations, including procedure development and training.
• Collaborate to coordinate installation, calibration, maintenance, and troubleshooting of instruments and equipment supporting radioisotope production.
• Ensure all work is performed in compliance with site safety and radiation protection guidelines.
• Support chemical inventory management, including ordering, storage evaluation, labeling, and disposal of chemicals.
• Support identification and implementation of approaches to improve instrument reporting, data-flow, infrastructure, and data analysis methods within a Laboratory Information System Framework.
• Lead and develop teams by fostering collaboration, aligning priorities with organizational goals, and creating a positive, inclusive work environment that promotes growth and innovation.

• Bachelor's degree in chemistry with hands-on experience in wet chemistry and radio analytical measurement using gamma spectroscopy, ICP-MS, ICP-OES, and/or alpha-spectroscopy.
• 12+ years of related experience with a Bachelor's degree; or 8 years with a Master's; or a PhD with 5 years of experience; or equivalent.
• Experience in a quality program compliant with FDA/cGMP (21 CFR 210/211) and ICH Guidance; preferably in an operational radiopharmaceutical production facility.
• Experience developing and implementing new analytical methods and documentation for radioisotope production.
• Strong attention to detail with ability to interpret federal regulations, guidance, and standards.
• Proven ability to develop, mentor, and grow team members, with clear expectations and constructive feedback.
• Excellent written and verbal communication skills, including technical writing and reporting to all levels of the organization.
• Strong…