Job Title: MICROBIOLOGY TECHNICIAN

Reports to: Manager, Sterility Assurance/Vice President, Quality

Classification: Full Time, Non-Exempt

Work Location: Rochester, MN – Onsite

Position Summary

The Microbiology Technician supports the execution of microbiological quality control (QC) methods and assists the microbiology QC team in radiopharmaceutical drug production. The Microbiology Technician applies microbiological knowledge to ensure the safe and effective manufacturing of sterile radiopharmaceutical drugs, adhering to regulatory standards and best practices.

Principal Responsibilities

• Execute microbiological methods for radioactive drug products in a GxP environment, including sterility, bioburden, and endotoxin testing of radioactive drug products, intermediates, and raw materials per USP and Standard Operating Procedures (SOPs).
• Perform Environmental Monitoring (EM) activities and assist with media fills to qualify aseptic operators.
• Analyze microbial samples to quantify growth and subculture pure isolates as required.
• Generate, analyze, and interpret microbiological test data; escalate results for review and interpretation by Microbiology leadership.
• Execute EM, bioburden, sterility, and other analyses for process samples, including radioactive samples, in coordination with the Production, Engineering, and Analytical groups.
• Investigate laboratory Out of Specification (OOS) results and Environmental Monitoring Excursions (EMEs) through Quality Management System (QMS) documents to provide effective corrective actions.
• Assist with investigating and implementing corrective actions stemming from other quality events such as CAPAs and deviations.
• Assist with the resolution of product/assembly issues in Operations/Manufacturing through coordination of investigations such as submitting and/or initiating Excursions/Deviations/OOS.
• Assist in evaluating tests on radiopharmaceutical manufacturing processes and components to assess microbiological impact.
• Assist in preparing protocols and reports by collecting and summarizing data and trends; contribute to Investigations, OOS reports, and the preparation of Quarterly Trend Reports.
• Execute activities in alignment with the site Contamination Control Strategy (CCS), including cleanroom practices, environmental monitoring, and aseptic behavior.
• Operate and maintain standard microbiology laboratory equipment.
• Track and manage inventory of laboratory supplies and maintain the microbiology lab; perform general laboratory housekeeping and maintenance of the department, premises, and equipment.
• Collaborate with cross-functional teams within the facility to ensure consistent and timely completion of all testing and other tasks in support of business needs.
• Participate in company-wide training on aseptic techniques and industry best practices for ISO classified and other controlled environments.
• Attend mandatory training as required by site regulatory requirements, management, and the Radiation Safety department.
• Ensure a safe and quality-minded working environment through conformance with training, general awareness, and compliance with safety/quality guidelines, SOPs, and radiation protection guidelines.
• Ensure product sterility and patient safety through strict adherence to aseptic behavior, gowning qualification, and cleanroom protocols; report health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
• Perform other general duties associated with the position as directed by supervisors; communicate daily needs to supervisor and perform other duties as assigned.
  
  

Required

QUALIFICATIONS & REQUIREMENTS

• Bachelor’s degree in a scientific field (biology, microbiology, or related discipline).
• Two years of relevant work experience, including experience with aseptic techniques while performing sterility, bioburden, and endotoxin testing of drug products, intermediates, and raw materials per USP and internal SOPs.
• Proficient computer skills, including data entry/processing, Microsoft® Office suite, and QMS programs.
• Good verbal and written communication skills.
• Demonstrated problem-solving and interpersonal skills, utilizing resourceful thinking and strong empathy.
• Detail-oriented with excellent organizational skills; analytically driven.
• Ability to foster an inclusive and cooperative work environment.
• Normal near visual acuity (20/20 with or without corrective lenses) and no impairment of color vision; testing for visual acuity and color discrimination required.
• Grasping/gripping and fine motor control abilities in both hands.
• Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
• Ability to work sitting and standing for extended periods.
• Ability to lift, move, transport, and position equipment and work items weighing up to 30 lbs. on a frequent basis.
  
  

Ideal

• Sterile pharmaceutical manufacturing and/or cGMP microbiology laboratory experience.
• Knowledge of working in a microbiology lab with live model USP microorganisms.
• Working knowledge of phase-appropriate cGMP with 21 CFR
• 210 &
• 211; introductory knowledge of EU Annex I.
• Understanding of microbiology and aseptic processing-specific language, and knowledge of pharmaceutical microbiology principles.
• Critical thinking skills to evaluate issues and identify potential solutions; ability to creatively address complex or new problems.
  
  

Compensation & Benefits

The hourly range for this role in Minnesota is $23.00–$34.00 per hour. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, and experience.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation assistance is available to qualified team members.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will.”

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.