Microbiologist

Job Title: Senior Microbiologist

Duration: 12+ Months (Possible extension)

Location: Arden Hills, MN 55112

Hybrid Role

Responsibilities:

• Seeking an experienced Sr. Microbiologist to provide technical support for contract manufactured devices, acquisition activities, new product development projects, microbiological risk assessments, and quality system activities across the organization.
• Operate in a highly collaborative environment, providing scientific expertise and risk-based decision making to support product quality, patient safety, and regulatory compliance.
• Serve as a microbiology SME supporting contract manufactured devices and external manufacturing partners.
• Support acquisition due diligence activities, product integration efforts, and manufacturing transfer initiatives.
• Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes.
• Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation.
• Evaluate microbiological impact associated with product, process, material, supplier, and facility changes.
• Support investigations, nonconformances, CAPAs, and other quality system activities requiring microbiology expertise.
• Partner with cross-functional teams to assess microbiological considerations related to manufacturing, design changes, commercialization activities, and supplier controls.
• Provide microbiology support for new product development projects and product lifecycle management activities.
• Participate in audits, inspections, and regulatory readiness activities as needed.
• Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements.
• Communicate microbiological risks, recommendations, and technical rationale to stakeholders across multiple functions and geographic regions.

Education/Experience:

• Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline.
• Minimum of five (5) years of experience in microbiology, quality, manufacturing, engineering, or related technical functions within a regulated industry.
• Experience performing scientific evaluations and technical risk assessments.
• Strong technical writing and documentation skills.
• Ability to independently manage multiple projects and priorities.
• Strong communication and stakeholder management skills.

Preferred:

• Medical device industry experience strongly preferred.
• Experience supporting contract manufactured products or external manufacturing partners.
• Experience supporting acquisitions, manufacturing transfers, or product transfer activities.
• Knowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principles.
• Experience supporting CAPA, investigations, nonconformance management, and change management activities.
• Familiarity with FDA regulations, ISO 13485, and other applicable global quality system requirements.
• Experience working in cross-functional and global project teams.
• Experience presenting technical recommendations to leadership and project teams.
• Ability to work effectively across multiple functions, sites, and geographic regions.