Senior Microbiologist

Advantage Technical; Minnesota; On-site; USD 67,000 - 96,000; Full time

Job summary

Advantage Technical is seeking a Senior Microbiologist in Minnesota to provide microbiology SME expertise across product development, contract manufacturing, risk assessments, and quality system activities. The role emphasizes risk-based decision-making and regulatory readiness within a regulated medical device environment.

The candidate will collaborate with Manufacturing, Quality, Regulatory Affairs, and external partners to evaluate microbiological risks, support investigations, assess

Qualifications

• Strong technical writing skills with experience in scientific reports and documentation.
• Ability to independently manage multiple projects and priorities in a regulated environment.
• Excellent communication and stakeholder management across functions and locations.

Responsibilities

• Serve as a microbiology SME for medical devices, contract manufacturing, and partners.
• Conduct microbiological risk assessments for products, materials, processes, facilities, and supplier changes.
• Evaluate microbiological impact of changes to products, processes, materials and suppliers.
• Author and review Microbiology Evaluation Reports (MBERs) and related documentation.
• Provide scientific recommendations to support product quality, regulatory compliance, and patient safety.
• Support new product development and lifecycle management initiatives.
• Assist in due diligence, product integration, and manufacturing transfer projects.
• Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams on microbiology considerations.

Skills

Technical writing

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in Microbiology / Biology / Biomedical Sciences

Job description

Industry: Medical Device / Life Sciences

Pay Rate: Up to $59.00 per hour

Travel: Approximately 10-20%

Work Authorization: Applicants must be authorized to work in the United States without employer sponsorship, now or in the future. Visa sponsorship is not available for this position.

Position Overview

A leading medical device organization is seeking an experienced Senior Microbiologist to provide technical expertise across product development, contract manufacturing, acquisitions, microbiological risk assessments, and quality system activities.

This individual will serve as a Microbiology Subject Matter Expert (SME), collaborating with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external manufacturing partners to evaluate microbiological risks, support technical investigations, assess product and process changes, and maintain compliance with applicable regulatory and quality standards.

The ideal candidate will have a strong scientific background, excellent technical documentation skills, and experience applying risk-based decision-making principles within a regulated manufacturing environment.

Key Responsibilities

Microbiology Expertise & Risk Assessment

• Serve as a microbiology SME supporting medical devices, contract manufacturing operations, and external manufacturing partners.
• Conduct microbiological risk assessments involving products, materials, manufacturing processes, facilities, and supplier changes.
• Evaluate the microbiological impact of changes to products, processes, materials, suppliers, and manufacturing environments.
• Author and review Microbiology Evaluation Reports (MBERs), scientific assessments, technical reports, and related documentation.
• Provide scientific recommendations to support product quality, regulatory compliance, and patient safety.

Product Development & Manufacturing Support

• Support new product development initiatives and ongoing product lifecycle management activities.
• Provide microbiological expertise during acquisition due diligence, product integration, and manufacturing transfer projects.
• Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams to assess microbiological considerations related to product design, commercialization, and process improvements.
• Support external manufacturing partners and suppliers with microbiological evaluations and technical guidance.

Quality Systems & Regulatory Compliance

• Support investigations, nonconformances, corrective and preventive actions (CAPAs), and other quality system activities.
• Assess microbiological risks associated with manufacturing deviations and process changes.
• Participate in audits, inspections, and regulatory readiness activities.
• Support compliance with applicable FDA regulations, ISO 13485, and global quality system requirements.
• Identify opportunities for continuous improvement and support enhancements to microbiology-related quality processes.

Cross-Functional Collaboration

• Partner with internal stakeholders and external business partners to address microbiological concerns and technical challenges.
• Communicate scientific findings, risk assessments, and recommendations to project teams and leadership.
• Manage multiple technical projects and priorities across various functions and geographic locations.
• Provide technical guidance to support business decisions and manufacturing initiatives.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in microbiology, quality, manufacturing, engineering, or a related technical function within a regulated industry.
• Experience conducting scientific evaluations, technical assessments, and risk analyses.
• Strong technical writing skills, including experience preparing scientific reports and supporting documentation.
• Demonstrated ability to independently manage multiple projects and competing priorities.
• Strong communication, collaboration, and stakeholder management skills.

Preferred Qualifications

• Experience working within the medical device industry.
• Previous experience supporting contract manufactured products, external suppliers, or manufacturing partners.
• Experience with acquisitions, product integration, technology transfers, or manufacturing transfers.
• Knowledge of microbiological principles and practices, including:
• Bioburden testing and evaluation
• Microbiological risk assessments
• Experience supporting CAPAs, investigations, nonconformance management, and change control processes.
• Familiarity with FDA regulations, ISO 13485, and global medical device quality requirements.
• Experience collaborating with cross-functional and geographically distributed teams.
• Ability to present technical findings and recommendations to management and project stakeholders.

Desired Skills & Competencies

• Strong scientific reasoning and technical problem-solving abilities.
• Sound judgment and risk-based decision-making skills.
• Ability to influence stakeholders through data-driven and scientifically supported recommendations.
• Excellent written and verbal communication skills.
• Strong organizational, time management, and project coordination abilities.
• Ability to work independently while collaborating across multiple departments and locations.

Compensation

Compensation: Up to $59.00 per hour.

Travel Requirements

Travel Requirements: Approximately 10-20% travel may be required to support manufacturing sites, audits, acquisitions, product transfers, and project-related business activities.

Employment Eligibility

Employment Eligibility: Candidates must be legally authorized to work in the United States without current or future employer sponsorship.