Lead and oversee all operational activities across the batch production value chain for Cell and Gene Therapy products
Ensure facility, systems, and workforce are equipped, trained, and maintained to meet advanced biomanufacturing demands
Collaborate with department leads to ensure compliance with corporate, regulatory, and industry standards (GMP, ISO, etc.)
Drive site operations to achieve business goals, scale capacity, and meet growth strategies
Own site P&L, budget management, cost control, and financial performance
Build, develop, and retain high-performing teams; set performance standards and support career development
Monitor and report on operational metrics and KPIs; implement continuous improvement and lean practices
Ensure EH&S performance aligns with or exceeds industry best practices
Lead digital transformation integrating AI, automation, and robotics into manufacturing processes
Act as strategic leader representing the site internally and externally, including regulatory authorities and community
Provide strategic leadership in engineering and manufacturing technology; drive innovation and integration of AI, robotics, automation, and digital systems
Lead deployment of advanced automation solutions (physical robots and intelligent software) to improve efficiency and throughput
Develop and implement digital manufacturing ecosystem with real-time data collection, analysis, and visualization
Champion electronic batch records, MES, and paperless compliant batch documentation and traceability
Oversee remote monitoring systems for continuous insights into equipment, environmental conditions, and product status
Drive high-throughput production with rapid quality release emphasizing automation, workflows, and robust quality controls
Collaborate with CTOs for AI and IT to align manufacturing technology with organizational goals and ensure cybersecurity and integration
Partner with Quality, Regulatory, and Supply Chain to support compliance, data integrity, and validation requirements
Lead capacity planning and process optimization using data-driven insights
Develop metrics and KPIs related to automation, digital performance, and manufacturing efficiency
Serve as technical authority on smart manufacturing systems, system integration, cybersecurity, and data governance
Requirements
Bachelor's degree in Engineering, Biotechnology, or related technical field required
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, Bioengineering, Systems Engineering, or MBA preferred
Minimum of 15 years of progressive senior leadership experience in biopharmaceutical manufacturing (Cell and Gene Therapy/advanced biologics)
Proven track record of leading large-scale manufacturing facilities with full P&L responsibility
Extensive experience integrating AI, automation, robotics, and digital systems into GMP operations
Demonstrated expertise implementing electronic batch records, MES, remote monitoring, and real-time data analytics
Strong background in engineering management, process optimization, Lean/Six Sigma methodologies
Experience managing multidisciplinary teams across manufacturing, quality, engineering, facilities, supply chain, and regulatory
Familiarity with regulatory compliance (FDA, EMA, Health Canada) and GMP/ISO standards
Experience with capacity planning, scale-up, and commercial manufacturing of complex biologics and cell/gene therapies
Deep understanding of manufacturing automation, robotics, AI, data analytics, and cybersecurity for biomanufacturing
Experience with MES, ERP systems, electronic batch recording, and smart manufacturing principles
Proven leadership, strategic planning, stakeholder management, and change management skills
Applicants must be legally eligible to work in Canada
Job title
Site Head – Chief Technology Officer, Manufacturing Operations
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