Manager, Quality Control Microbiology, TerraPower Isotopes

TerraPower•Everett, WA

9d•Onsite

About The Position

TerraPower Isotopes (TPI) is seeking an experienced Quality Control Manager to support Ac-225 production at its Everett manufacturing facility. The role oversees environmental monitoring and product testing to enable production of Active Pharmaceutical Ingredient starting material in accordance with pharmaceutical industry requirements. It also plays a key role in developing and performing analytical methods, procedures, and protocols that support cleanroom operations and actinium-225 disposition. The position provides operational leadership for the QC Microbiology team and manages microbiology laboratory activities supporting environmental monitoring, water systems, raw materials, in-process work, and product release testing. It is accountable for compliant QC execution, data integrity, documentation, review, reporting, and Certificate of Analysis issuance. The manager leads development and lifecycle management of microbiological methods and laboratory systems, and owns the site Contamination Control Strategy in collaboration with cross-functional teams. The role reports to the Director, Quality and works with Site Quality Systems, Operations, QC, Engineering, R&D, Procurement, Project Management, Manufacturing, Validation, Quality Assurance, Regulatory Affairs, and Radiation Safety. It supports laboratory readiness and equipment and system qualification, investigates quality events, represents microbiology during inspections and audits, and trains and mentors staff. Occasional off-shift or weekend support may be required; travel is 0–10%.

Requirements

Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life sciences discipline.
Relevant industry experience of 12 or more years with a bachelor's degree, 8 or more years with a master's degree, or 5 or more years with a PhD; equivalent combinations of education and experience may be considered.
At least 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, ICH guidance, and applicable microbiological quality standards.
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 requirements.
Experience leading regulatory inspections, audits, investigations, CAPAs, and quality risk assessments.
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.
Ability to safely lift up to 25 pounds.
Ability to perform or tolerate the described job functions, including extended sitting, bending or stooping, grasping or gripping, prolonged repetitive work, visually and audio-focused work, stairs, typing or keyboard use, and a standard and/or seated work environment for more than 8 hours per day; accommodations may be considered following an individualized assessment.
Occasional off-shift or weekend support may be required.

Nice To Haves

Advanced degree in a relevant discipline.
Experience supporting sterile manufacturing, radiopharmaceutical production, biologics manufacturing, or other highly regulated pharmaceutical operations.
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.

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 comply with site safety requirements, biosafety standards, and radiological safety procedures.
Lead development, qualification, validation, transfer, implementation, and lifecycle management of microbiological test methods and laboratory systems in compliance with cGMP and applicable regulatory requirements.
Oversee end-to-end QC execution, data integrity, documentation, review, and reporting to support compliant batch disposition and Certificate of Analysis issuance.
Develop, implement, maintain, and continuously improve the site Contamination Control Strategy in collaboration with cross-functional stakeholders.
Author, review, and approve SOPs, protocols, validation reports, specifications, and other GMP documentation related to microbiological testing and contamination control.
Lead contamination-source risk assessments and recommend mitigation strategies throughout facility design, qualification, and routine operations.
Serve as the microbiology Subject Matter Expert 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 in laboratory automation, data management, reporting, 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.
Balance quality, operational, biosafety, and radiological safety requirements while maintaining a compliance-focused culture.