Senior Microbiologist

Senior Microbiologist

Location: Arden Hills, MN

Work Arrangement: Hybrid

Pay Rate: $58.00-$62.99 per hour

Shift: Business First Shift | 8:00 AM-4:30 PM

Travel: Approximately 10-20%

Dress Code: Professional

Position Overview

We are seeking an experienced Senior Microbiologist to provide scientific and technical expertise in support of contract-manufactured medical devices, acquisition activities, new product development, microbiological risk assessments, and quality system initiatives.

In this role, you will serve as a Microbiology Subject Matter Expert (SME), collaborating with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external business partners. You will evaluate microbiological risks, support investigations, assess product and process changes, and help ensure compliance with applicable quality system requirements.

The ideal candidate is a technically strong microbiology professional with experience in regulated industries, excellent documentation skills, and the ability to make risk-based decisions that support product quality, patient safety, and regulatory compliance.

Key Responsibilities

• Serve as a microbiology subject matter expert supporting contract-manufactured medical devices and external manufacturing partners.

• Support acquisition due diligence, product integration, and manufacturing transfer initiatives.

• Conduct 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 the microbiological impact of product, process, material, supplier, and facility changes.

• Provide microbiology expertise for investigations, nonconformances, Corrective and Preventive Actions (CAPAs), and other quality system activities.

• Collaborate with cross-functional teams to address microbiological considerations related to manufacturing, design changes, commercialization, and supplier controls.

• Support new product development and product lifecycle management activities.

• Participate in audits, inspections, and regulatory readiness initiatives as needed.

• Contribute to continuous improvement initiatives and enhancements to microbiology-related quality systems.

• Communicate microbiological risks, recommendations, and scientific rationale to stakeholders across functions, sites, and geographic regions.

Minimum Qualifications

• Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline.

• At least five (5) years of experience in microbiology, quality, manufacturing, engineering, or related technical functions within a regulated industry.

• Experience conducting scientific evaluations and technical risk assessments.

• Strong technical writing, documentation, and analytical skills.

• Ability to independently manage multiple projects, priorities, and deadlines.

• Excellent communication and stakeholder management skills.

Preferred Qualifications

• Medical device industry experience strongly preferred.

• Experience supporting contract-manufactured products or external manufacturing partners.

• Experience with acquisitions, manufacturing transfers, or product transfer activities.

• Knowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principles.

• Experience with CAPAs, investigations, nonconformance management, and change management.

• Familiarity with FDA regulations, ISO 13485, and applicable global quality system requirements.

• Experience working with cross-functional and global project teams.

• Ability to present technical recommendations to leadership and project stakeholders.

Desired Competencies

• Strong scientific reasoning and technical problem-solving skills.

• Effective risk-based decision-making.

• Ability to influence stakeholders using sound scientific rationale.

• Excellent written and verbal communication.

• Strong organizational, planning, and project management skills.

• Ability to collaborate effectively across multiple functions, sites, and geographic regions.

Work Schedule and Travel

• Shift: Business First Shift, 8:00 AM-4:30 PM.

• Work Arrangement: Hybrid.

• Travel: Approximately 10-20% may be required to support site activities, audits, acquisitions, manufacturing transfers, project teams, and other business needs.

Candidate Submission Requirements

• Typing Assessment: Minimum typing speed of 45 words per minute (WPM).

• Accuracy: Typing accuracy percentage must also be provided.

• Submission Compliance: Both typing speed and accuracy results must be documented on the candidate submission form. Submissions missing either requirement may be disqualified.

Education Requirement

A bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline is required.

Work Authorization

Applicants must be authorized to work in the United States without visa sponsorship, either now or in the future. Candidates who require current or future visa sponsorship cannot be considered for this position.

Opportunity Overview

This is an opportunity to apply advanced microbiology expertise in a collaborative, regulated medical device environment. The Senior Microbiologist will play an important role in evaluating product and process risks, supporting manufacturing and business integration initiatives, and advancing quality, patient safety, and regulatory compliance.

Pay Rate: $58.00-$62.99 per hour | Hybrid | Arden Hills, Minnesota

Pay Details: $58.00 to $62.99 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.