Job Title: MICROBIOLOGIST Reports to: Director, Quality Classification: Full Time, Exempt Work Location: Rochester, MN - Onsite ABOUT NUCLEUS RADIOPHARMA: Founded by Mayo Clinic and Eclipse Ventures, Nucleus RadioPharma is a Contract Manufacturing and Development Organization built to ensure patients can access potentially life-saving radiopharmaceuticals through technologies to modernize the clinical development, manufacturing, and supply chain of these promising new treatment tools. POSITION SUMMARY: The Microbiologist will play a key role in the execution of microbiological QC methods and assist in the supervision of a highly effective microbiology QC team to support radiopharmaceutical drug production. PRINCIPAL RESPONSIBILITIES: Leads the execution of microbiological methods for radioactive drug products in a GxP environment, including Sterility and Bioburden testing of radioactive 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. Prepare and analyze Biological Indicators in support of Validation and Qualification activities. Perform environmental monitoring (EM) activities. Analyze microbial samples to quantify growth and subculture pure isolates as required. Provide support and assistance with environmental monitoring activities. Assists in supervision of the Microbiology team which includes training, coaching, and relaying performance and development management to supervisor. Provides support and assistance for laboratory personnel in daily activities to fulfill client and GMP requirements. Responsible for training Microbiology Techs on cGMP guidelines 21 CFR 210, 211, 212 (as applicable) and Microbiological test methods. Responsible for training QC Techs in microbiological testing methods. Serves as Subject Matter Expert for Microbiological testing on site. Collaborate with other groups within the facility to understand goals and communicate changes throughout the organization. Writes necessary SOPs, Validation Protocols and Validation Report. General laboratory housekeeping duties and maintenance of the department, premises, and equipment. Manage inventory of laboratory supplies. Collaborate with other team members to ensure the consistent and timely completion of all testing and other tasks in support of business needs. Ensure a safe and quality-minded working environment through conformance with training, general awareness, compliance to safety/Quality guidelines and SOPs, and radiation protection guidelines. Attend mandatory trainings as required by site regulatory requirements and management. Perform other general duties associated with the position as required by supervision. Communicate laboratory budget and laboratory staffing needs to supervisor. Performs other duties as assigned.