Senior Microbiologist

Reports to: Sr. Manager, Sterility Assurance

Classification: Full Time, Exempt

Work Location: Rochester, MN – On‑Site

Nucleus Radio Pharma is an end-to-end CDMO accelerating radiopharmaceutical therapies through isotope‑flexible manufacturing, breakthrough partnerships, and end-to-end innovation that brings complex medicines to patients. We are driven by a vision of a world where every patient with cancer has access to the right therapeutic, at the right time.

The Senior Microbiologist provides technical leadership and independently executes microbiological quality control activities that support the manufacture of sterile radiopharmaceuticals in a cGMP environment. This role serves as the subject matter expert for microbiological testing, environmental monitoring, contamination control, aseptic processing support, investigations, and data trending, partnering cross‑functionally with Manufacturing, Quality Assurance, Engineering, Validation, and Technical Operations. Working with minimal supervision, the Senior Microbiologist mentors laboratory personnel and drives scientific excellence to ensure the highest standards of product quality, regulatory compliance, and patient safety.

• Lead the execution of microbiological methods for radioactive drug products in a GxP environment, including Sterility and Bioburden testing of drug products, intermediates, and raw materials per USP and Standard Operating Procedures (SOP).
• Review and interpret FDA, EU, and other international regulations, standards, and guidelines covering sterilization and microbial contamination control in the manufacture of aseptic radiopharmaceutical products.
• Perform Growth Promotion testing per USP methods for various microbiological media, and prepare and analyze Biological Indicators in support of validation and qualification activities.
• Lead and support the site’s microbiology and Environmental Monitoring (EM) program, including sampling strategy, cleanroom monitoring, data review, trending, and evaluation of alert and action level excursions to ensure compliance with cGMP and contamination control requirements.
• Analyze microbial samples to quantify growth and subculture pure isolates as required, providing support and assistance with environmental monitoring activities.
• Lead microbiological investigations involving environmental monitoring excursions, contamination events, out-of-specification (OOS) results, deviations, and CAPAs, using scientific, risk-based decision making to identify root causes and implement effective corrective actions.
• Provide microbiological support for sterile radiopharmaceutical manufacturing operations, including aseptic processing, cleanroom and classified area activities, hot cell or isolator operations, line clearance, and campaign-based production activities.
• Support contamination control strategy execution by identifying microbial risks, evaluating trends, and partnering with Manufacturing, Quality Assurance, Engineering, Facilities, MSAT, and Validation to drive effective corrective actions.
• Author, revise, and review SOPs, validation protocols, validation reports, technical assessments, and investigation documentation in accordance with cGMP, USP, FDA, and applicable regulatory expectations.
• Support aseptic process simulations, media fills, cleaning and disinfection effectiveness studies, cleanroom qualification, smoke studies, and process performance activities, as applicable.
• Provide day‑to‑day technical guidance, mentoring, and training to Microbiology Technicians and other laboratory personnel, serving as a technical resource in support of the Manager, Sterility Assurance.
• Develop and deliver…