Quality Control Microbiologist (Radiopharmaceuticals)

Location: Everett, Washington, United States. The role may require occasional evening or weekend work, 10–20% travel, and compliance with U.S. Government export-control reviews for foreign nationals.

Salary: $117,922–$176,883 per year.

Company

hirify.global develops advanced nuclear technologies and medical isotopes through its hirify.global Isotopes division, supporting radiopharmaceutical applications and cancer treatments.

What you will do

• Design, qualify, implement, and perform microbiological testing for environmental monitoring, water systems, raw materials, and products.
• Conduct and interpret sterility, bioburden, endotoxin, growth promotion, microbial identification, and other specialized tests.
• Develop SOPs, protocols, validation documents, and contamination control strategy documentation.
• Support laboratory equipment and method qualification, calibration, data integrity, biosafety, and radiological safety.
• Lead contamination risk assessments and help implement site-specific contamination control measures during facility design and commissioning.
• Act as a microbiology subject matter expert during audits, inspections, investigations, and cross-functional projects.

Requirements

• Bachelor’s degree in Microbiology, Biology, or a related life sciences discipline, or equivalent experience.
• At least five years of QC Microbiology experience in pharmaceutical, radiopharmaceutical, biologics, or similarly regulated GMP environments.
• Strong knowledge of aseptic technique, microbial testing, environmental monitoring, and contamination control.
• Experience with GMP quality systems, including investigations, CAPA, change control, and audit readiness.
• Familiarity with FDA, ICH, EU Annex 1, biosafety, and radiation safety requirements.
• Strong technical writing, regulatory interpretation, troubleshooting, analytical, communication, and decision-making skills.

Nice to have

• Radiopharmaceutical or nuclear medicine manufacturing experience.
• Facility startup, cleanroom commissioning, or laboratory build-out experience.
• Experience serving as a microbiology SME during regulatory inspections.
• Experience with rapid microbiological methods or automated microbial identification systems.
• ASQ, Lean Six Sigma, or project management certification.

Culture & Benefits

• Startup environment focused on building laboratory capabilities and quality systems.
• Collaboration with Quality Assurance, QC Radiochemistry, R&D, Operations, Engineering, Project Management, and Radiation Safety.
• Medical, vision, dental, life, disability, and gender affirmation benefits.
• Parental leave, 401(k), 21 days of accrued annual PTO, and 10 paid holidays.
• Relocation assistance and professional and educational support opportunities.