Manager, Quality Control Microbiology, TerraPower Isotopes

Equal employment opportunity, including veterans and individuals with disabilities

Manager, Quality Control Microbiology TPI TerraPower Isotopes (TPI) is seeking an experienced Quality Control Manager to support production of Ac-225 at the Everett manufacturing facility.

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 are conducted in accordance with site safety requirements, biosafety standards, and radiological safety procedures.
• Lead the development, qualification, validation, transfer, implementation, and lifecycle management of microbiological test methods and laboratory systems in compliance with cGMP and applicable regulatory requirements.
• Accountable for end-to-end QC execution, data integrity, documentation, review, and reporting to support compliant batch disposition and Certificate of Analysis (CoA) issuance.
• Own the development, implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS) in collaboration with Manufacturing, Engineering, Validation, Quality Assurance, and other cross-functional stakeholders.
• Author, review, and approve SOPs, protocols, validation reports, specifications, and other GMP documentation related to microbiological testing and contamination control.
• Lead risk assessments for contamination sources and recommend mitigation strategies throughout facility design, qualification, and routine operations.
• Serve as the microbiology Subject Matter Expert (SME) 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.

Key Qualifications and Skills

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life sciences discipline; advanced degree preferred.
• 12+ years of relevant industry experience with a Bachelor's degree, 8+ years with a Master's degree, or 5+ years with a PhD; equivalent combinations of education and experience may be considered.
• Minimum 3-5 years of progressive leadership experience managing technical or quality laboratory teams.
• Extensive experience operating within FDA and cGMP-regulated environments, including 21 CFR Parts 210 and 211, ICH guidance, and applicable microbiological quality standards.
• Experience supporting sterile manufacturing, radiopharmaceutical production, biologics manufacturing, or other highly regulated pharmaceutical operations preferred.
• 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 (CCS) requirements.
• Experience leading regulatory inspections, audits, investigations, CAPAs, and quality risk assessments.
• 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.
• 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. Occasional off-shift or weekend support may be required.
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Job Functions:

Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation.

View the full Job Description (https://www.click2apply.net/AjKrArsNmxeZ5cZRRU5YZ8)​

PI287994798