Manager Quality Control Microbiology

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. 

Manager, Quality Control Microbiology (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 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.

Responsibilities:

• 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 procurement, storage, labeling, usage, and disposal in accordance with applicable regulations.
• Drive continuous improvement initiatives related to laboratory automation, data management, reporting, Laboratory Information Management Systems (LIMS), and digital workflows.
• Train and mentor QC personnel and operational staff on aseptic practices, microbiological controls, contamination prevention, and GMP expectations.
• Build collaborative partnerships across Quality, Manufacturing, Engineering, Validation, Regulatory Affairs, and Radiation Safety functions.
• Balance quality, operational, biosafety, and radiological safety requirements while maintaining a strong compliance-focused culture.

Key Qualifications and Skills

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life sciences discipline; advanced degree preferred.
• 12+ years of relevant industry experience with a Bachelor's degree, 8+ years with a Master's degree, or 5+ years with a PhD; equivalent combinations of education and experience may be considered.
• Minimum 3-5 years of progressive leadership experience managing technical or quality laboratory teams.
• Extensive experience operating within FDA and cGMP-regulated environments, including 21 CFR Parts 210 and 211, ICH guidance, and applicable microbiological quality standards.
• Experience supporting sterile manufacturing, radiopharmaceutical production, biologics manufacturing, or other highly regulated pharmaceutical operations preferred.
• Demonstrated expertise in environmental monitoring, sterility assurance, contamination control, water systems monitoring, microbial identification, and microbiological method validation.
• Strong working knowledge of EU GMP Annex 1 and Contamination Control Strategy (CCS) requirements.
• Experience leading regulatory inspections, audits, investigations, CAPAs, and quality risk assessments.
• Familiarity with radiological controls, radiation safety practices, and laboratory operations supporting radioisotope production is highly desirable.
• Experience with LIMS, laboratory automation, electronic data management systems, and data integrity requirements.
• Strong technical writing, documentation review, and communication skills.
• Excellent analytical, troubleshooting, root-cause analysis, and problem-solving capabilities.
• Demonstrated ability to build high-performing teams, develop talent, foster engagement, and create an inclusive culture.
• Ability to adapt to changing priorities and work effectively in a dynamic manufacturing environment. Occasional off-shift or weekend support may be required.
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Job Functions:

Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation.  Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations.  An applicant's ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.

• Motor Abilities: Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
• Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds.
• Repetitive work: Prolonged
• Special Senses: Visual and audio focused work
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
• Travel required 0-10%

TerraPower Isotopes' technology is controlled for export by various agencies of the U.S. Government.  TerraPower Isotopes must evaluate applicants who are foreign nationals (other than asylees, refugees, or lawful permanent residents) in accordance with U.S. Government export control requirements.  To facilitate TerraPower's export control reviews, you will be asked as part of the application process to identify whether you are a U.S. Citizen or national, asylee, refugee, or lawful permanent resident of the United States.  Government export authorization approval times vary.  Based on the business needs for a particular position, TerraPower Isotopes may not consider a foreign national from a country if it is impracticable to obtain timely Government export approval.

Job details

Salary Range: $153, 861 - $205,149

*Any salary offered within the posted salary band is based on market data and commensurate with the selected candidate’s qualifications and experience.  This range is specific to Washington State.

Benefits:

• Competitive Compensation
• Salary, eligible to participate in discretionary short-term incentive payments
• Comprehensive Medical and Wellness Benefits
  • Medical
  • Vision
  • Dental
  • Life and Disability
  • Gender Affirmation Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
  • 21 days of annually accrued PTO
• Generous Holiday Schedule
  • 10 paid holidays
• Relocation Assistance
• Professional and Educational Support Opportunities

TerraPower Career and Benefits information: https://www.terrapower.com/careers/