Credentials that matter
Skills and tools
- GMP
- Capa
- FDA
- ICH
Required qualifications
- 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 including investigations, CAPA, change control, and 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 ability to interpret federal regulations, guidance, and standards
- Excellent written and verbal communication skills including technical writing proficiency
About this role
TerraPower Isotopes seeks a Quality Control Microbiologist to establish and execute microbiological testing programs for radiopharmaceutical manufacturing. You'll develop lab capabilities from the ground up, ensure GMP compliance, and serve as the microbiology subject matter expert in a startup environment advancing nuclear medicine treatments. This role bridges pharmaceutical QC best practices with radiological safety requirements.
Responsibilities
- Design, qualify, and implement microbiological test methods for environmental monitoring, water systems, raw materials, and product testing
- Participate in selection, qualification, and validation of microbiological laboratory equipment and methods
- Author SOPs, protocols, and validation documents related to microbiological testing and Contamination Control Strategy
- 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, data integrity, biosafety and radiological safety requirements
- Lead or support development and implementation of site-specific Contamination Control Strategy in collaboration with cross-functional stakeholders
- Lead risk assessments for contamination sources and recommend mitigation strategies throughout facility design and commissioning
- Serve as subject matter expert for regulatory audits and internal inspections focused on microbiological controls
- Independently assess and troubleshoot complex microbiological issues, proposing and implementing corrective/preventive actions
- Train QC and Operations staff in aseptic techniques and microbiology best practices
Preferred qualifications
- 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 subject matter expert
- Experience with rapid microbiological methods or automated microbial identification systems
Location, schedule, and travel
Washington State based; onsite position; occasional evening or weekend work may be required.
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