Quality Control Manager, TerraPower Isotopes

Location: Everett,Washington,United States

Title:                Quality Control Manager, TerraPower Isotopes

Location:        Everett, Washington 

TerraPower Isotopes (TPI™) 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. TPI currently produces actinium-225 for the growing alpha therapy market and intends to expand.

The TerraPower Isotopes (TPI) business 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. In addition, as a federal contractor, TerraPower has instituted an Affirmative Action Plan (AAP) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.

Quality Control Manager – TPI

TerraPower 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 be responsible for oversight of the testing activities to enable production of Active Pharmaceutical Ingredient (API) starting material consistent with pharmaceutical industry requirements and play a critical role in the development and performance of analytical methods, procedures and protocols that will be used for the characterization of actinium-225.

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

Responsibilities:

•    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 with TPI teams to coordinate installation, calibration, maintenance, and troubleshooting of instruments and equipment that support TPI radioisotope production.

•    Ensure all work is performed in compliance with site safety and radiation protection guidelines.

•    Support the management of the chemical inventory, including ordering, evaluation for proper storage, labeling and disposal of chemicals.

•    Support identification and implementation of approaches to improve instrument reporting, data-flow, infrastructure, and data analysis methods withing a Laboratory In formation 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.

Key Qualifications and Skills

•    A Bachelors level degree in chemistry with demonstrated post-graduate hands-on experience performing wet chemistry and radioanalytical measurement using techniques including gamma spectroscopy, ICP-MS, and ICP-OES, and/or alpha-spectroscopy.

•    12+ years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years experience; or equivalent experience. 

•    Experience working within a quality program compliant to FDA/cGMP requirements 21 CFR 210/211 and ICH Guidance; preferably, experience in an operational radiopharm