Job Description

Job Title: Microbiology Manager

Job Type: Contract to Hire

Position Summary:

The Microbiology Manager will play a critical leadership role within the Quality organization, supporting departmental strategy and serving as a subject matter expert in microbiology. This individual will oversee day-to-day microbiological testing activities—including product release, validation support, and environmental monitoring—while supervising and developing a team of microbiologists in a GMP-compliant pharmaceutical or biotechnology environment.

Key Responsibilities:

• Lead and coordinate microbiological testing activities, including product release and protocol-driven validation testing.
• Supervise, train, and mentor microbiology staff; provide performance feedback and development planning.
• Conduct and review microbial identification and provide technical expertise on microbiological testing methodologies.
• Oversee and interpret environmental monitoring (EM) results, sterility testing, growth promotion, microbial limits, and other critical microbiological assays.
• Review batch records, laboratory data, EM reports, and equipment logs to ensure compliance with cGMP, FDA, and company quality standards.
• Participate in or lead method validation, troubleshooting investigations, and the development and revision of SOPs and quality documentation.
• Ensure laboratory operations remain in a state of audit readiness; generate regular reports and manage documentation lifecycle.
• Collaborate cross-functionally with Quality Assurance, Manufacturing, and Regulatory Affairs to support business objectives and ensure timely product release.
• Promote a culture of safety, compliance, and continuous improvement within the laboratory.

Required Qualifications:

• Bachelor’s degree in Microbiology, Biology, or a related scientific field (Master’s preferred).
• 10+ years of experience in microbiology or quality control within a GMP-regulated pharmaceutical or biotech setting.
• At least 3–4 years of supervisory or managerial experience with direct reports.
• Demonstrated expertise in environmental monitoring programs and aseptic processes.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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