Senior Manager, QC Microbiology

Our client is a biotechnology company based in Vancouver, Canada specializing in the discovery and development of antibody-based medicines. Leveraging advanced antibody engineering, computational technologies, and integrated drug development capabilities, the company works to advance innovative therapeutics for patients with significant unmet medical needs.

With a collaborative, science-driven culture and a focus on translating research into clinical applications, the organization offers the opportunity to contribute to the development of next-generation biologic therapies in a dynamic, fast-paced environment.

They are looking for a highly skilled Senior Manager, QC Microbiology to lead GMP QC-Micro operations at their biological Drug Substance (DS) clinical manufacturing facility in Vancouver, BC. The new hire will also support the company’s network of external Contract Manufacturing Organizations (CMOs), Contract Testing Labs (CTLs), and other collaborators. Taking ownership of the site’s Contamination Control Program, the Senior Manager will ensure alignment with regulatory expectations and industry best practices while serving as the go-to technical expert and mentor across microbial methods, environmental monitoring (EM) programs, utilities monitoring, and contamination investigations.

This is a hands-on leadership role where the candidate’s microbiology and contamination control expertise directly supports the quality of therapies that reach patients.

The role is full-time, permanent, and in-office.

Responsibilities:

• Leading the QC Microbiology function, providing strategic and technical direction while building, coaching, and developing a high-performing QC Microbiology team
• Shaping the QC Microbiology strategy and capabilities needed to support company’s evolving development and manufacturing programs, including contamination control strategy (CCS), microbiological method strategy, environmental monitoring (EMPQ), utilities monitoring, raw materials, facility readiness, and risk-based testing approaches
• Providing leadership and oversight of internal QC Microbiology operations, including bioburden, endotoxin, microbial identification, growth promotion, environmental monitoring, water testing, trending, and Disinfectant Efficacy Testing (DET) studies
• Setting priorities and coordinating QC Microbiology resources and activities across internal laboratory operations, development and manufacturing programs, and external testing
• Developing and mentoring QC Microbiology team members, fostering technical excellence, strong aseptic practices, ownership, collaboration, and sound scientific decision-making
• Leading troubleshooting and investigations related to microbiological assays, deviations, OOS results, environmental monitoring excursions, and other microbiological events, ensuring scientifically sound and timely resolution
• Providing technical and strategic SME leadership for GMP cell banking, in-process bulk adventitious agent testing, including mycoplasma and viral testing, and other microbiological assays
• Ensuring internal and external QC Microbiology data packages are accurate, scientifically sound, and compliant with GMP requirements and ALCOA++ data integrity principles
• Partnering cross-functionally with QA, Analytical Development, Manufacturing Operations, CMC, and other stakeholders to define microbiology strategies, establish effective workflows, manage priorities, and support compliant execution across development and manufacturing programs
• Contributing to broader QC and CMC planning by identifying microbiology risks, capability needs, external testing requirements, and opportunities to strengthen the function as the team and pipeline grow

Qualifications:

• 12+ years of hands-on QC microbiology experience in a regulated GMP setting, along with a Bachelor’s degree in Microbiology or a related life sciences field, and can provide strategic and technical leadership across microbial methods, environmental monitoring, utilities monitoring, contamination control, and microbiological investigations
• You have demonstrated experience leading, mentoring, or developing scientists or analysts
• You have experience working with external laboratories, CMOs, or other testing partners and can provide effective scientific oversight, build strong partnerships, and hold external organizations accountable for quality and delivery
• You can translate program and regulatory needs into practical microbiology strategies, testing approaches, priorities, and capabilities
• You can balance leadership and strategic thinking with hands-on technical engagement and are comfortable stepping in to support troubleshooting, investigations, and complex microbiological decisions when needed
• You are comfortable setting priorities and balancing internal laboratory needs, program deliverables, and external partner activities in a dynamic environment
• You communicate clearly, influence effectively across functions and team, and bring calm, structured decision-making to complex or time-sensitive situations
• You thrive in a growing team where priorities evolve and leaders need to combine strategy, people leadership, scientific expertise, and practical execution

Compensation:

• CAD $135,000-170,000 annual base salary
• Equity
• Annual bonus dependent on team and company performance
• 6% RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Paid time off
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

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