Senior Microbiologist IV - Hybrid Contract

Intellectt INC; Arden Hills (MN); Hybrid; USD 66,000 - 68,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Novozen Health Care in Arden Hills, MN is seeking a Microbiologist IV on a contract basis to serve as a microbiology SME for contract-manufactured medical devices and external partners. The role emphasizes risk assessment, documentation, and collaboration across Manufacturing, Quality, Regulatory, and R&D teams to ensure product integrity.

The ideal candidate has a bachelor's degree in microbiology or related field, at least five years in regulated environments, strong writing and

Qualifications

• Bachelor's degree in Microbiology or related field.
• Minimum 5 years of microbiology/quality/manufacturing experience in a regulated environment.
• Strong writing and stakeholder management skills.

Responsibilities

• Serve as microbiology SME for contract-manufactured medical devices and external partners.
• Support due diligence, product integration, transfers, and new product development.
• Conduct microbiological risk assessments for products, materials, processes, facilities, and supplier changes.
• Author/review MBERs, technical assessments, and scientific documentation.
• Evaluate microbiological impacts of product, process, materials, suppliers, and facilities.
• Support investigations, CAPAs, and quality system activities requiring microbiology expertise.
• Collaborate with Manufacturing, Quality, Regulatory, R&D, and external partners.
• Provide microbiology support for development, commercialization, and lifecycle management.
• Participate in audits, inspections, and regulatory readiness activities.
• Travel approximately 10–20% for site activities, audits, acquisitions, and transfers.

Skills

Technical writing

Stakeholder management

Project management

Multitasking

Communication

Education

Bachelor's degree in Microbiology

5+ years in regulated microbiology

Job description

Novozen Health Care in Arden Hills, MN is seeking a Microbiologist IV on a contract basis to serve as a microbiology SME for contract-manufactured medical devices and external partners. The role emphasizes risk assessment, documentation, and collaboration across Manufacturing, Quality, Regulatory, and R&D teams to ensure product integrity.

The ideal candidate has a bachelor's degree in microbiology or related field, at least five years in regulated environments, strong writing and