Quality Control Microbiologist

TerraPower LLC.•Everett, WA

27d•$117,922 - $176,883•Onsite

About The Position

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. Quality Control Microbiologist The Quality Control Microbiologist will establish, implement, and execute microbiological testing programs supporting radiopharmaceutical manufacturing in compliance with Good Manufacturing Practices (GMP), FDA and ICH guidance, EU Annex 1, biosafety standards, and radiation safety requirements. This role will develop laboratory capabilities, perform routine and specialized microbiological testing, support contamination control initiatives, and serve as a microbiology subject matter expert (SME) during audits and cross‑functional projects. The QC Lead Microbiologist will work closely with Quality Assurance, QC Radiochemistry, R&D, Operations, Engineering, Project Management and Radiation Safety. This position is ideal for professionals experienced in startup environments who enjoy building systems while maintaining strong hands‑on laboratory presence. The role will report to the Director of Quality.

Requirements

Bachelor’s degree in Microbiology, Biology, or related life sciences discipline (or equivalent experience).
Minimum 5 years of QC Microbiology experience in pharmaceutical, radiopharmaceutical, biologics, or similarly regulated GMP environments.
Strong knowledge of aseptic technique, microbial testing methods, environmental monitoring, and contamination control principles.
Experience with GMP Quality Systems (investigations, CAPA, change control, audit readiness).
Familiarity with regulatory expectations including FDA, ICH, and EU Annex 1.
Ability to work independently in a fast‑paced or startup environment.
Strong attention to detail, with the ability to interpret federal regulations, guidance, and standards. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
Strong independent troubleshooting, analytical, problem-solving skills and decision-making skills, such as those developed in fast-paced environments, and other nuclear or radiopharmaceutical environments is highly preferred.
Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment. Occasional evening or weekend work might be required to support production operations or project deliverables.
The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Nice To Haves

Experience in radiopharmaceutical or nuclear medicine manufacturing environments.
Experience with facility startup, cleanroom commissioning, or labs built from the ground up.
Prior participation in regulatory inspections as a microbiology SME.
Experience with rapid microbiological methods or automated microbial identification systems.
Certification in Quality (e.g., ASQ), Lean Six Sigma, or project management.

Responsibilities

Design, qualify, and implement microbiological test methods for environmental monitoring, water systems, raw materials, and product testing.
Participate in the selection, qualification, and validation of microbiological laboratory equipment and methods.
Author SOPs, protocols, and validation documents related to microbiological testing and Contamination Control Strategy (CCS).
Perform and interpret microbiological tests, including environmental monitoring, sterility testing, bioburden, endotoxin, growth promotion, and microbial identification.
Maintain compliant laboratory operations, including media management, equipment calibration, qualification, laboratory data integrity and follow biosafety and radiological safety requirements.
Lead or support development and implementation of a comprehensive site-specific CCS in collaboration with cross-functional stakeholders.
Lead risk assessments for contamination sources and recommend mitigation strategies throughout facility design and commissioning.
Serve as the subject matter expert (SME) for regulatory audits and internal inspections focused on microbiological controls.
Independently assess and troubleshoot complex microbiological issues, proposing and implementing corrective/preventive actions as needed.
Train QC and Operations staff in aseptic techniques and microbiology best practices.
Build strong working relationships across technical and operational functions.
Balance Quality requirements with safety, such as biosafety and radiation safety, in all Quality initiatives.