QC Microbiology Manager

<p>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. </p> <p>We are looking for a highly skilled QC Microbiology Manager to lead GMP QC-Micro laboratory operations at AbCellera’s biological Drug Substance (DS) clinical manufacturing facility in Vancouver, Canada and to support external Contract Manufacturing Organizations (CMOs), Contract Testing Labs (CTLs), and other external collaborators. This position is responsible for strategic ownership of the Contamination Control Program at the site in alignment with regulatory expectations and industry best practices. You will provide deep technical mentorship, and troubleshooting expertise across microbial methods, EM programs, utilities monitoring, and contamination investigations.</p> <p><strong>How you might spend your days</strong></p> <ul> <li>Serving as the QC Microbiology SME for key strategic decisions related to microbiology, including contamination control (CCS), microbiological method strategy, environmental monitoring (EMPQ), utilities monitoring, raw materials, facility readiness, and risk-based testing approaches</li> <li>Leading all Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending</li> <li>Coordinating the execution of Disinfectant Efficacy (DET) studies to support our GMP manufacturing facility cleaning program</li> <li>Overseeing external microbiological testing, including reviewing and approving methods and testing results for raw materials, in-process, intermediate, and final product testing (DS, DP)</li> <li>Providing technical SME oversight of GMP cell banking and in-process bulk adventitious agents (mycoplasma, viral, etc.)</li> <li>Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution</li> <li>Leading or approving investigations of microbiology-related deviations, OOS results, EM excursions </li> <li>Verifying internal/contractor/partner QC-Micro data packages (batch records, test results, validation reports) for accuracy and adherence to ALCOA++ data integrity standards</li> <li>Providing daily in-lab mentorship to the QC team, fostering strong technique, aseptic practices, and microbiological best practices</li> <li>Ensuring microbiology labs and adjacent QC spaces remain inspection-ready, including GMP housekeeping and equipment readiness</li> <li>Interfacing with all auditors (internal and external) to ensure positive audit outcomes</li> <li>Collaborating with Analytical Development, Quality Assurance, Materials, and Manufacturing teammates to ensure smooth operational flow and timely release/testing</li> <li>Creating, editing, and adhering to Standards and Standard Operating Procedures (SOPs)</li> </ul> <p><strong>We'd love to hear from you if</strong></p> <ul> <li>You bring deep Microbiology experience in a regulated (GMP) QC environment, and are confident in leading microbial methods, EM programs, utilities monitoring, and contamination troubleshooting</li> <li>You have experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments</li> <li>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</li> <li>You communicate clearly, collaborate well, and maintain calm, structured decision-making under pressure</li> <li>You demonstrate