Senior Manager, QC Microbiology

Each of us cares about someone who will need medicines. Our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients. We are looking for a highly skilled Senior Manager, QC Microbiology to lead GMP QC-Micro operations at our biological Drug Substance (DS) clinical manufacturing facility in Vancouver. You will also support our network of external Contract Manufacturing Organizations (CMOs), Contract Testing Labs (CTLs), and other collaborators. You will take ownership of the site's Contamination Control Program, ensuring alignment with regulatory expectations and industry best practices while serving as the go-to technical expert and mentor across microbial methods, environmental monitoring, utilities monitoring, and contamination investigations.

Responsibilities

Lead the GMP QC Microbiology function, providing strategic and technical direction while building, coaching, and developing a high-performing team; Shape QC Microbiology strategy and capabilities, including contamination control strategy, microbiological method strategy, environmental monitoring, utilities monitoring, raw materials, facility readiness, and risk-based testing; Provide leadership and oversight of internal QC Microbiology operations, including bioburden, endotoxin, microbial identification, growth promotion, environmental monitoring, water testing, trending, and Disinfectant Efficacy Testing studies; Set priorities and coordinate QC Microbiology resources across internal laboratory operations, development and manufacturing programs, and external testing; Develop and mentor team members, fostering technical excellence, aseptic practices, ownership, and sound scientific decision-making; Lead troubleshooting and investigations related to microbiological assays, deviations, OOS results, environmental monitoring excursions, and other microbiological events; Provide technical and strategic SME leadership for GMP cell banking, in-process bulk adventitious agent testing (including mycoplasma and viral testing), and other microbiological assays; Ensure internal and external QC Microbiology data packages are accurate, scientifically sound, compliant with GMP, and aligned with ALCOA++ data integrity principles; Partner cross-functionally with QA, Analytical Development, Manufacturing Operations, CMC, and other stakeholders to define microbiology strategies and support compliant execution; Contribute to broader QC and CMC planning by identifying microbiology risks, capability needs, external testing requirements, and opportunities to strengthen the function; Support the site's Contamination Control Program and serve as go-to technical expert and mentor; Support network of external CMOs, Contract Testing Labs, and other collaborators

Requirements

14+ years of hands-on QC microbiology experience in a regulated GMP setting; Bachelor's degree in Microbiology or a related life sciences field; strategic and technical leadership across microbial methods, environmental monitoring, utilities monitoring, contamination control, and microbiological investigations; demonstrated experience leading, mentoring, or developing scientists or analysts; experience working with external laboratories, CMOs, or other testing partners, with effective scientific oversight and accountability for quality and delivery; ability to translate program and regulatory needs into practical microbiology strategies, testing approaches, priorities, and capabilities; ability to balance leadership and strategic thinking with hands-on technical engagement; comfort setting priorities across internal laboratory needs, program deliverables, and external partner activities in a dynamic environment; clear communication and ability to influence across functions; calm, structured decision-making in complex or time-sensitive situations; ability to thrive in a growing team where priorities evolve

Benefits

Equity; Annual bonus dependent on team and company performance; 6% non-match RRSP contribution; CAD $1,500 annual Active Lifestyle Allowance; Annual vacation; Professional development opportunities; Comprehensive health benefits; Scientific and technical mentorship; Team and social groups to build community and connections