Senior Microbiologist - Regulatory & Method Development Lead

Element Materials Technology; Eagan (MN); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Element Materials Technology is seeking a Senior Microbiologist for our Eagan, MN laboratory. The role focuses on microbiological testing for antimicrobial, pharmaceutical, medical device, and related regulated industries, ensuring data integrity and regulatory compliance.

You will lead challenging projects, collaborate with clients, and contribute to studies supporting product development, regulatory approvals, and patient safety. Strong writing and leadership are essential.

Formación

• BS or MS in Microbiology, Biology, Medical Laboratory Science, or related field.
• 5+ years of microbiology experience in regulated environments (cGLP/ISO 17025/FDA).
• Experience with reusable medical device testing and sterilization validation preferred.
• Strong writing, data interpretation, and communication skills.

Responsabilidades

• Design and execute microbiological studies to address client objectives and regulatory requirements.
• Lead antimicrobial efficacy testing programs using standard and custom methods.
• Oversee microbiological testing including cleaning, disinfection, sterilization validation, bioburden and sterility testing.
• Review protocols, raw data, and reports to ensure quality and regulatory compliance.
• Mentor laboratory staff and maintain cGLP/ISO 17025 compliance.

Conocimientos

Microbiology expertise

Analytical thinking

Scientific writing

Project management

Educación

BS/MS in Microbiology

Herramientas

FDA/ISO standards

USP standards

Descripción del empleo

Element Materials Technology is seeking a Senior Microbiologist for our Eagan, MN laboratory. The role focuses on microbiological testing for antimicrobial, pharmaceutical, medical device, and related regulated industries, ensuring data integrity and regulatory compliance.

You will lead challenging projects, collaborate with clients, and contribute to studies supporting product development, regulatory approvals, and patient safety. Strong writing and leadership are essential.