Manager, Quality Control Microbiology, TerraPower Isotopes

The Terra Power Isotopes® (TPI™) division has been established to pursue medical isotopes development--advancing nuclear science for significant human health benefits. We seek to support revolutionary radio therapies for treatments of various cancers through the supply of radioisotopes. Terra Power 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 Terra Power Isotopes program is an integral part of the Washington State based Terra Power 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. Terra Power’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. 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 federal, state, or local law.

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 be responsible for oversight of environmental monitoring and product testing 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 to support cleanroom operations and disposition 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.

• Provide operational leadership for the QC Microbiology team, including staffing, performance management, employee development, succession planning, and prioritization of laboratory activities.
• Manage QC Microbiology laboratory operations supporting environmental monitoring, water systems, raw material testing, in-process testing, and product release testing.
• Ensure QC laboratory operations are conducted in accordance with site safety requirements, biosafety standards, and radiological safety procedures.
• Lead the development, qualification, validation, transfer, implementation, and lifecycle management of microbiological test methods and laboratory systems in compliance with cGMP and applicable regulatory requirements.
• Accountable for end-to-end QC execution, data integrity, documentation, review, and reporting to support compliant batch disposition and Certificate of Analysis (CoA) issuance.
• Own the development, implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS) in collaboration with Manufacturing, Engineering, Validation, Quality Assurance, and other cross-functional stakeholders.
• Author, review, and approve SOPs, protocols, validation reports, specifications, and other GMP documentation related to microbiological testing and contamination control.
• Lead risk assessments for contamination sources and recommend mitigation strategies throughout facility design, qualification, and routine operations.
• Serve as the microbiology Subject Matter Expert (SME) during regulatory inspections, customer audits, and internal assessments.
• Lead microbiology-related investigations, deviations, CAPAs, change controls, and quality risk management activities.
• Oversee laboratory readiness, including equipment qualification, calibration, maintenance, media management, inventory control, and data integrity compliance.
• Support installation, qualification, maintenance, and troubleshooting of instruments and laboratory systems used in radioisotope production.
• Support management of laboratory chemical inventories, including…