Lead Microbiologist - cGLP/ISO 17025 Expert

Element Materials Technology; Eagan (MN); Hybrid; USD 100,000 - 130,000; Full time

Job summary

Element Materials Technology is seeking a Senior Microbiologist to join our Eagan, MN laboratory, performing/leading microbiological testing and method development for antimicrobial, medical device, and pharmaceutical sectors. You will manage studies, ensure data integrity, and contribute to regulatory submissions.

The role involves leading projects, mentoring staff, and working in a cGLP/ISO 17025 environment to deliver scientifically robust results on time for clients and registrations.

Qualifications

• BS or MS in Microbiology, Biology, Medical Laboratory Science, or related scientific discipline.
• Excellent analytical writing and problem-solving skills.
• Strong communication and project management abilities.

Responsibilities

• Design and execute custom microbiological studies to address client objectives and regulatory requirements.
• Lead antimicrobial efficacy testing programs using standard and customized methods.
• Oversee reusable medical device validation studies including cleaning, disinfection, and sterilization validations.
• Perform and supervise microbiological testing including bioburden, sterility, endotoxin, and environmental monitoring.
• Develop, qualify, verify, and validate microbiological methods per industry standards and regulatory expectations.
• Collaborate with clients to understand project goals and develop testing strategies.
• Analyze and interpret microbiological data and prepare clear technical reports.
• Maintain compliance with cGLP, ISO 17025, and Element quality systems.

Skills

Communication skills

Analytical thinking

Problem solving

Project management

Education

BS or MS in Microbiology, Biology, Medical Laboratory Science, or related discipline

Job description

Element Materials Technology is seeking a Senior Microbiologist to join our Eagan, MN laboratory, performing/leading microbiological testing and method development for antimicrobial, medical device, and pharmaceutical sectors. You will manage studies, ensure data integrity, and contribute to regulatory submissions.

The role involves leading projects, mentoring staff, and working in a cGLP/ISO 17025 environment to deliver scientifically robust results on time for clients and registrations.