Co - Director of Care leading nursing operations, quality, and resident care for a Toronto long - term care organization. Managing infection control, compliance, medication safety, and nursing teams.
About the role
- Senior MSAT leader launching BlueRock Therapeutics’ Toronto cell therapy manufacturing operation. Leading technology transfers, automation, GMP readiness, and clinical supply execution.
Responsibilities
- Build a high-performing MSAT organization bridging Process Development with GMP manufacturing and supporting internal and external operations
- Identify, evaluate, and deploy automation solutions in non-GMP and GMP environments to improve process robustness and operational efficiency
- Drive operational readiness and technical startup of the new cell therapy manufacturing facility in the Greater Toronto Area
- Advance BlueRock’s pipeline through internal and external technology transfers, strategic manufacturing support, and complex process investigations
- Establish and maintain process monitoring frameworks for proactive, data-driven decision-making and continuous improvement
- Lead automation and digital technology deployment across manufacturing and R&D operations
- Develop automation value propositions, business cases, and innovative GMP-compliant solutions
- Execute technology transfers of BlueRock assets into the new facility and establish a high-performing operation securing reliable clinical supply
- Establish the MSAT operating model and scalable technical processes across the product lifecycle
- Enable growth across the internal and external manufacturing network through standardized ways of working and governance
- Build, mentor, and lead an MSAT organization across disciplines
- Partner with Process Development on technology transfer, process knowledge, documentation readiness, and GMP training
- Partner with Manufacturing to develop a lean, repeatable, risk-tolerant internal NPI process
- Own process monitoring databases and use statistical tools to monitor variability, analyze trends, detect shifts, quantify variation, and drive insights
- Lead investigations and technical risk assessments for major deviations, OOS/OOT, and atypical events, including root cause analysis and CAPAs
- Drive process optimization, standardization, lean problem solving, and compliance
- Lead material qualification, supplier changes, and risk management for critical raw materials, reagents, and single-use systems
- Partner with Supply Chain and Quality on supplier network robustness and dual sourcing strategies
- Partner with Process Development on technology roadmaps and industry technology trends
- Lead facility startup activities with Engineering, Manufacturing, Quality, and Project teams
- Define the manufacturing technology transfer framework and oversee product and process transfers into the new facility
- Align stakeholders on business plans for pipeline asset transfers
Requirements
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Life Sciences, or a related field
- 15+ years of experience
- Extensive leadership experience within biotechnology manufacturing organizations, with progressive responsibility across MSAT, process engineering, technical operations, or manufacturing support functions
- Previous experience starting up a new GMP operation
- Previous experience designing and implementing new technologies
- Strong background in cell therapy and advanced biologics manufacturing, including experience supporting products through development, clinical manufacturing, and commercialization
- Demonstrated success managing technology transfers and building effective partnerships across internal manufacturing sites, CMOs, and external collaborators
- Proven ability to lead complex technical organizations, drive operational excellence, and deliver results in a fast-paced and evolving environment
- Strong knowledge of regulatory frameworks
Benefits
- Equal opportunity workplace
- Disability-related accommodation during the recruitment process
- Human-rights-protected accommodation during the recruitment process
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