Manager, Quality Control Microbiology, TerraPower Isotopes
About The Position
TerraPower Isotopes (TPI) is seeking an experienced Quality Control Manager to support production of actinium-225 at its Everett manufacturing facility. The role oversees environmental monitoring and product testing to enable production of Active Pharmaceutical Ingredient (API) starting material in accordance with pharmaceutical industry requirements. The manager will contribute to developing and performing analytical methods, procedures, and protocols that support cleanroom operations and disposition of actinium-225. The position reports to the Director, Quality and works with multidisciplinary teams across site Quality Systems, Operations, Quality Control, Engineering, R&D, Procurement, and Project Management. It provides operational leadership for the QC Microbiology team and ensures laboratory activities meet cGMP, regulatory, site safety, biosafety, and radiological safety requirements. The manager is accountable for compliant QC execution, data integrity, documentation, review, reporting, and batch disposition support, and leads the site's Contamination Control Strategy and continuous improvement efforts. The role also supports laboratory readiness and radioisotope-production systems, leads microbiology-related quality events and risk assessments, serves as a microbiology subject matter expert during inspections and audits, and trains and mentors QC and operational personnel. 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.
- At least 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.
- 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.
- 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 the listed job functions, including extended sitting, bending or stooping, grasping or gripping, fine motor work, prolonged repetitive work, visual and audio-focused work, stair use, and typing or keyboard work in a standard or seated environment for more than 8 hours per day.
- High degree of trust and integrity, open communication, respect, and a commitment to teamwork.
Nice To Haves
- Advanced degree in Microbiology, Biology, Biochemistry, or a related life sciences 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.
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 risk assessments for contamination sources 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 functions.
- Balance quality, operational, biosafety, and radiological safety requirements while maintaining a compliance-focused culture.
Benefits
- Competitive compensation, including eligibility to participate in discretionary short-term incentive payments.
- Comprehensive medical and wellness benefits.
- Medical insurance.
- Vision insurance.
- Dental insurance.
- Life and disability benefits.
- Gender affirmation benefits.
- Parental leave.
- 401(k) plan.
- 21 days of annually accrued paid time off.
- 10 paid holidays.
- Relocation assistance.
- Professional and educational support opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
