Radiopharmaceutical QC Microbiology Manager

TerraPower LLC.; Everett (WA); Sur place; USD 154 000 - 205 000; Plein temps

Avantages offerts par ce poste

Competitive Compensation

Discretionary incentive payments

Medical and Wellness Benefits

401k Plan

PTO 21 days annually

Generous Holiday Schedule 10 holidays

Relocation Assistance

Professional and Educational Support

Résumé du poste

TerraPower Isotopes is hiring a Manager, Quality Control Microbiology for the Everett facility. The role leads the QC Microbiology team, overseeing environmental monitoring, material testing, and product release testing in a cGMP environment supporting Ac-225 production.

You will drive method validation, CCS development, SOP ownership, and regulatory preparation while coordinating with Quality, Manufacturing, Validation, and Regulatory teams. Occasional off-shift work may be required.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, or related life sciences.
• 12+ years of relevant industry experience with a Bachelor's degree, 8+ years with a Master's, or 5+ years with a PhD.
• Minimum 3-5 years of progressive leadership experience managing technical or quality laboratory teams.
• Extensive experience in FDA and cGMP-regulated environments, including 21 CFR Parts 210 and 211.
• Experience with sterile manufacturing, radiopharmaceutical production or related regulated ops preferred.
• Expertise in environmental monitoring, sterility assurance, contamination control, water systems monitoring, and microbiological method validation.
• Experience with LIMS, laboratory automation, and data integrity requirements.
• Strong technical writing, documentation review, and communication skills.

Responsabilités

• Provide operational leadership for the QC Microbiology team and lab activities.
• Oversee QC Microbiology lab operations including environmental monitoring and product testing.
• Ensure operations comply with safety, biosafety, and radiological standards.
• Lead development and validation of microbiological test methods and lab systems.
• Manage end-to-end QC execution, data integrity, documentation, and CoA issuance.
• Develop and maintain Contamination Control Strategy with cross-functional stakeholders.
• Author, review, and approve GMP documentation related to microbiological testing.
• Lead risk assessments for contamination sources and mitigation strategies.

Connaissances

Leadership

GMP compliance

Microbiology

Regulatory inspections

LIMS

Formation

Bachelor's in Microbiology or related

Advanced degree preferred

Outils

LIMS

Laboratory automation

Description du poste

TerraPower Isotopes is hiring a Manager, Quality Control Microbiology for the Everett facility. The role leads the QC Microbiology team, overseeing environmental monitoring, material testing, and product release testing in a cGMP environment supporting Ac-225 production.

You will drive method validation, CCS development, SOP ownership, and regulatory preparation while coordinating with Quality, Manufacturing, Validation, and Regulatory teams. Occasional off-shift work may be required.