Microbiology Technician

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

Description

PRINCIPAL RESPONSIBILITIES:

• 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).
• Perform growth promotion and other microbiological testing required per USP; environmental monitoring (EM) activities and media fills to qualify operators; Sterility, Bioburden, aseptic sterility, and more as required.
• Analyze microbial samples to quantify growth and subculture pure isolates as required.
• Collaborate with cross-functional teams within the facility to align on objectives, effectively communicate process changes across the organization, and contribute to Investigations and OOS reports, and the preparation of Quarterly Trend Reports.
• Investigate and/or approve Out of Specifications (OOS) and Environmental Monitoring Excursions (EMEs) by authoring/approving Quality Management System (QMS) documents such as Deviations and CAPAs to provide corrective actions.
• General laboratory housekeeping duties and maintenance of the department, premises, and equipment.
• Track and Manage inventory of laboratory supplies and maintaining the microbiology lab and Sterility suites.
• 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, management, and Rad safety training.
• Perform other general duties associated with the position by supervisors. Communicate daily needs to supervisor.
• Performs other duties as assigned. Other daily responsibilities may include:
• Analyze and interpret microbiological/test results.
• Assist in evaluating tests on radiopharmaceutical manufacturing processes and components to assess microbiological impact.
• Prepare protocols and reports by collecting, summarizing data and trends.
• Participate company-wide training on aseptic techniques and industry best practices for ISO classified/controlled environments.
• Proficient in the use of standard microbiology laboratory equipment.
• Execution for EM, Bioburden, Sterility, analyses for process samples, including radioactive samples, in coordination with the Production, Engineering and Microbiology groups.
• Assist with the resolution of product/assembly issues in Operations/Manufacturing, through coordination of investigations, submitting and/or initiating Excursions/Deviations/OOS.
  
  

Qualifications & Requirements

• Bachelor's or Technical College degree in biology/microbiology required.
• Experience preferred (preferably within sterile pharmaceutical manufacturing facility and cGMP Microbiology lab) or other related scientific discipline in a cGMP environment, or equivalent combination of education and experience.
• Working knowledge of 21 CFR 210, 211, 212 and CCS (as per EU Annex1), preferred.
• Good Verbal and written communication skills
• Advanced computer skills, including data entry/processing, communication tools and QMS.
• Problem-solving skills and resourceful thinking, Strong empathy, and interpersonal skills.
• Detail-oriented with excellent organizational skills, Attention to detail and analytically driven.
• Experience with aseptic techniques while performing Sterility, and Bioburden testing of drug products, intermediates, and raw materials per USP and internal Standard Operating Procedures
• Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, ICH, and FDA guidance, etc.) required.
• Knowledge of sterile pharmaceutical manufacturing cleanliness, aseptic processing, and associated standards and guidance. Working in a microbiology lab with live model USP microorganisms.
• Understanding of microbiology and aseptic processing specific language, and knowledge of microbiology principles including Environmental Monitoring, Sterility, Bioburden, CCS.
• Adaptable to quickly changing priorities in a fast-paced and dynamic work environment.
• In-depth critical thinking skills to evaluate issues and identify a potential solution.
  
  

Creatively addresses complex or new problems.

• Advanced interpersonal skills, including but not limited to problem-solving, teamwork development, and train other team members. Works well with others to achieve common goals.
• Ability to foster an inclusive and cooperative work environment. Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands.
• Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.
• 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.
• Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
• Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
• Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
  
  

The Fine Print

The hourly range in Minnesota is $28.00 to $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, experience, and location.

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 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.