Microbiology and Contamination Control Manager

Overview

In this leadership role you drive the site-wide contamination control program and oversee QC Microbiology and Environmental Monitoring. You will integrate CCS into design, operations, and process development, ensuring GMP-compliant, inspection-ready labs. You lead cross-functional teams to reduce contamination risk and enable regulatory readiness. The position offers high visibility and strategic influence across manufacturing, QA, and engineering, with a focus on proactive contamination control and continuous improvement.

Responsibilities

• Lead and develop QC Microbiology and Environmental Monitoring teams
• Oversee microbiological testing for raw materials, in-process, and finished products
• Maintain GMP-compliant laboratories and readiness for inspections
• Own and improve the site-wide Contamination Control Strategy (CCS)
• Embed contamination control into facility design, material flows, and operations
• Lead data-driven risk analysis to inform CCS decisions
• Act as site SME for microbiology, aseptic processing, and cleanroom operations
• Support deviations, investigations, CAPAs, and change controls
• Assist audits and regulatory inspections as the microbiology lead
• Collaborate with Manufacturing, MSAT, QA, and Engineering to embed contamination control in aseptic practices, cleaning, process design, tech transfer, and validation
• Lead trend analysis of microbiology and environmental monitoring data
• Drive initiatives to reduce contamination risks and improve performance
• Deliver site-wide training on contamination control and microbiology practices
• Foster a proactive risk identification and continuous improvement culture

Key requirements

• Significant GMP pharmaceutical or biologics manufacturing experience
• Expertise in aseptic processing, environmental monitoring, and contamination control
• Proven experience leading microbiology or laboratory teams
• Strong knowledge of global GMP regulations, including EU Annex 1
• Excellent stakeholder management and ability to influence across a matrix organization
• A degree in Microbiology, Biological Sciences or a related discipline is preferred

• Stakeholder management
• Cross-functional collaboration
• Leadership and people development
• Aseptic processing
• Environmental monitoring
• Contamination control

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