Senior Microbiology Scientist Aseptic & GMP Lead

Nucleus RadioPharma; Rochester (MN); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer matching

Relocation assistance

Job summary

Nucleus RadioPharma in Rochester, MN is seeking a Senior Microbiologist to provide technical leadership in microbiology quality control for sterile radiopharmaceuticals in a cGMP environment.

You will mentor technicians, manage environmental monitoring, investigations, and ensure regulatory compliance, collaborating across Manufacturing, QA, Engineering, Validation, and Technical Operations.

Qualifications

• Bachelor’s degree in Biology, Microbiology, or a related scientific discipline.
• Minimum 5 years of experience in a cGMP microbiology laboratory supporting sterile pharmaceutical manufacturing.
• Demonstrated experience writing microbiological QC SOPs, test methods, protocols, and reports.
• Experience with aseptic techniques while performing Sterility, Endotoxin, Particulate Matter, and Bioburden testing of drug products, intermediates, and raw materials per USP and SOPs.

Responsibilities

• Lead microbiological methods for radioactive drug products in a GxP environment, including Sterility and Bioburden testing.
• Review FDA/EU regulations and guidelines on sterilization and contamination control.
• Perform Growth Promotion testing per USP and prepare Biological Indicators for validation/qualification.
• Oversee microbiology and Environmental Monitoring programs, including sampling strategy, EM data review, and trend analysis.
• Analyze microbial samples, support environmental monitoring activities, and assist with EM excursions.

Skills

Communication

Problem solving

Interpersonal skills

Team collaboration

Education

Bachelor degree in Biology/Microbiology

Master’s degree preferred

Job description

Nucleus RadioPharma in Rochester, MN is seeking a Senior Microbiologist to provide technical leadership in microbiology quality control for sterile radiopharmaceuticals in a cGMP environment.

You will mentor technicians, manage environmental monitoring, investigations, and ensure regulatory compliance, collaborating across Manufacturing, QA, Engineering, Validation, and Technical Operations.