QC Microbiology Manager
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Each of us cares about someone who will need medicines. That's why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are looking for a highly skilled QC Microbiology Manager to lead day-to-day QC laboratory operations with a primary focus on Microbiology. You will provide strong in-lab presence, deep technical mentorship, and troubleshooting expertise across microbial methods, EM programs, utilities monitoring, and contamination investigations. In addition to your microbiology leadership, you will support broader QC functions such as stability, sample management, raw materials testing, and analytical assays. How you might spend your days Serving as the QC Microbiology SME for key strategic decisions related to microbiology, including contamination control, microbiological method strategy, environmental monitoring, utilities monitoring, facility readiness, and risk-based testing approaches. Leading all Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution Providing daily in-lab mentorship to the QC team, fostering strong technique, aseptic practices, and microbiological best practices Ensuring microbiology labs and adjacent QC spaces remain inspection-ready, including GMP housekeeping and equipment readiness Reviewing micro data packages, protocols, reports, and testing documentation for accuracy and adherence to ALCOA++ principles Collaborating with Analytical Development, Quality Assurance, Materials, and Manufacturing teammates to ensure smooth operational flow and timely release/testing We'd love to hear from you if You bring deep, hands-on Microbiology experience in a regulated (GMP) QC environment, and are confident in leading microbial methods, EM programs, utilities monitoring, and contamination troubleshooting You have experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments You have 10+ years of hands-on QC microbiology experience in a GMP setting, in addition to a Bachelor's degree in Microbiology or a related life sciences field You communicate clearly, collaborate well, and maintain calm, structured decision-making under pressure You demonstrate strong ownership, accountability, and a solutions-focused mindset when supporting analysts or resolving micro-related issues You are organized, detail-oriented, and committed to inspection readiness and data integrity You thrive in an environment requiring in-lab leadership, cross-functional coordination, and prioritization of operational needs
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Company Intel
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