Quality Control Microbiologist The Quality Control Microbiologist will establish, implement, and execute microbiological testing programs supporting radiopharmaceutical manufacturing in compliance with Good Manufacturing Practices (GMP), FDA and ICH guidance, EU Annex 1, biosafety standards, and radiation safety requirements.
This role will develop laboratory capabilities, perform routine and specialized microbiological testing, support contamination control initiatives, and serve as a microbiology subject matter expert (SME) during audits and cross-functional projects.
The QC Lead Microbiologist will work closely with Quality Assurance, QC Radiochemistry, R&D, Operations, Engineering, Project Management and Radiation Safety.
This position is ideal for professionals experienced in startup environments who enjoy building systems while maintaining strong hands-on laboratory presence.
The role will report to the Director of Quality.
Responsibilities:- Design, qualify, and implement microbiological test methods for environmental monitoring, water systems, raw materials, and product testing.
- Participate in the selection, qualification, and validation of microbiological laboratory equipment and methods.
- Author SOPs, protocols, and validation documents related to microbiological testing and Contamination Control Strategy (CCS).
- Perform and interpret microbiological tests, including environmental monitoring, sterility testing, bioburden, endotoxin, growth promotion, and microbial identification.
- Maintain compliant laboratory operations, including media management, equipment calibration, qualification, laboratory data integrity and follow biosafety and radiological safety requirements.
- Lead or support development and implementation of a comprehensive site-specific CCS in collaboration with cross-functional stakeholders.
- Lead risk assessments for contamination sources and recommend mitigation strategies throughout facility design and commissioning.
- Serve as the subject matter expert (SME) for regulatory audits and internal inspections focused on microbiological controls.
- Independently assess and troubleshoot complex microbiological issues, proposing and implementing corrective/preventive actions as needed.
- Train QC and Operations staff in aseptic techniques and microbiology best practices.
- Build strong working relationships across technical and operational functions.
- Balance Quality requirements with safety, such as biosafety and radiation safety, in all Quality initiatives.
Key Qualifications and Skills - Bachelor's degree in Microbiology, Biology, or related life sciences discipline (or equivalent experience).
- Minimum 5 years of QC Microbiology experience in pharmaceutical, radiopharmaceutical, biologics, or similarly regulated GMP environments.
- Strong knowledge of aseptic technique, microbial testing methods, environmental monitoring, and contamination control principles.
- Experience with GMP Quality Systems (investigations, CAPA, change control, audit readiness).
- Familiarity with regulatory expectations including FDA, ICH, and EU Annex 1.
- Ability to work independently in a fast-paced or startup environment.
- Strong attention to detail, with the ability to interpret federal regulations, guidance, and standards. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
- Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
- Strong independent troubleshooting, analytical, problem-solving skills and decision-making skills, such as those developed in fast-paced environments, and other nuclear or radiopharmaceutical environments is highly preferred.
- Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment. Occasional evening or weekend work might be required to support production operations or project deliverables.
- The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.
Preferred Qualifications- Experience in radiopharmaceutical or nuclear medicine manufacturing environments.
- Experience with facility startup, cleanroom commissioning, or labs built from the ground up.
- Prior participation in regulatory inspections as a microbiology SME.
- Experience with rapid microbiological methods or automated microbial identification systems.
- Certification in Quality (e.g., ASQ), Lean Six Sigma, or project management.
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. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. An applicant's ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.
- Motor Abilities: Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
- Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds.
- Repetitive work: Prolonged
- Special Senses: Visual and audio focused work
- Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
- Travel required 10-20%
Job detailsSalary Range: $116,852 - $151,757
*Any salary offered within the posted salary band is based on market data and commensurate with the selected individual's qualifications experience. This range is specific to Washington State.
Benefits:- Competitive Compensation
- Salary, eligible to participate in discretionary short-term incentive payments
- Comprehensive Medical and Wellness Benefits
- Medical
- Vision
- Dental
- Life and Disability
- Gender Affirmation Benefits
- Parental Leave
- 401k Plan
- Generous Paid Time Off (PTO)
- 21 days of annually accrued PTO
- Generous Holiday Schedule
- Relocation Assistance
- Professional and Educational Support Opportunities
TerraPower Career and Benefits information: https://www.terrapower.com/careers/
