QC Microbiology Manager

AbCellera•Vancouver, BC

2d•CA$105,600 - CA$132,000•Onsite

About The Position

AbCellera is seeking a highly skilled QC Microbiology Manager to lead GMP QC-Micro laboratory operations at their biological Drug Substance (DS) clinical manufacturing facility in Vancouver, Canada. This role will also support external Contract Manufacturing Organizations (CMOs), Contract Testing Labs (CTLs), and other external collaborators. The position holds strategic ownership of the Contamination Control Program at the site, ensuring alignment with regulatory expectations and industry best practices. The manager will provide deep technical mentorship and troubleshooting expertise across microbial methods, Environmental Monitoring (EM) programs, utilities monitoring, and contamination investigations.

Requirements

Deep Microbiology experience in a regulated (GMP) QC environment
Confidence in leading microbial methods, EM programs, utilities monitoring, and contamination troubleshooting
Experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments
10+ years of hands-on QC microbiology experience in a GMP setting
Bachelor’s degree in Microbiology or a related life sciences field
Clear communication skills
Ability to collaborate well
Ability to maintain calm, structured decision-making under pressure
Strong ownership, accountability, and a solutions-focused mindset
Organized, detail-oriented, and committed to inspection readiness and data integrity
Ability to thrive in a fast-paced environment, cross-functional coordination, and prioritization of operational needs

Responsibilities

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
Leading all Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending
Coordinating the execution of Disinfectant Efficacy (DET) studies to support the GMP manufacturing facility cleaning program
Overseeing external microbiological testing, including reviewing and approving methods and testing results for raw materials, in-process, intermediate, and final product testing (DS, DP)
Providing technical SME oversight of GMP cell banking and in-process bulk adventitious agents (mycoplasma, viral, etc.)
Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution
Leading or approving investigations of microbiology-related deviations, OOS results, EM excursions
Verifying internal/contractor/partner QC-Micro data packages (batch records, test results, validation reports) for accuracy and adherence to ALCOA++ data integrity standards
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
Interfacing with all auditors (internal and external) to ensure positive audit outcomes
Collaborating with Analytical Development, Quality Assurance, Materials, and Manufacturing teammates to ensure smooth operational flow and timely release/testing
Creating, editing, and adhering to Standards and Standard Operating Procedures (SOPs)