Senior Microbiologist – Risk & Manufacturing SME

Advantage Technical; Minnesota; Presencial; USD 67.000 - 96.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Technical writing

Risk assessment

Cross-functional collaboration

Educación

Bachelor's degree in Microbiology / Biology / Biomedical Sciences

Descripción del empleo

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