BioPharma Operations Leader

Summary

Liane Smith
Driving Quality by Bringing Together People, Processes and Technology from clinical to commercial production.
Experienced senior leader with global expertise in the biopharma industry. Proven strengths in technology innovation, operations management and business development. Well-known for quality-mindedness and collaboration. Recognized for leading scientific teams to achieve exceptional results.
CORE COMPETENCIES:
? Vaccines and Cell Culture
? Biopharmaceutical Manufacturing
? Chemistry and Manufacturing Controls
? cGMP Documentation
? Quality Systems
? Bioprocess Development
? Biopharmaceutical Validation & Technology Transfer  
? Regulatory Inspections (global)
? Formulation & Sterile Fill/Finish
?Business Process Improvement (Six Sigma Certified)
? Project Management and Execution (PMP Certified)
? Vaccine Delivery Systems

Timeline

  1. Director General Biologics Manufacturing Centre , National Research Council of Canada, Montreal QC

    Responsible for all aspects of operationalizing an end to end GMP Biologics Manufacturing Centre, first of its kind in Canada, to address the immediate COVID-19 crisis and the need to increase Canada's biomanufacturing capacity.

  2. -
    Senior Director Technical Operations, Therapure Biopharma Inc.

    Direct Manufacturing Science & Technology and Validation Service functions across all contract manufacturing operations for existing and new products. Accountable for the technology transfer, validation, optimization, robustness and daily support of manufacturing processes.

  3. -
    Deputy Director Projects, Manufacturing Technology, Sanofi Pasteur Ltd.

    Operations project lead for a new biopharmaceutical product and operations team member for a number of development and technology transfer projects.

     

  4. -
    Director Pharmaceutical Science and Technology, Sanofi Pasteur Ltd.

    Led a scientific and technical team of 25 plus people to design and implement strategic and process improvement projects for final formulations filling, visual inspection and packaging operations. 

    • Completed a major change management initiative on job redesign
  5. -
    Senior Director Global Technology Innovation, Sanofi Pasteur Ltd., Toronto

    Managed a global network for innovation and supported business collaborations in vaccine delivery devices.

    • Developed a global network and technology road-map for innovation in fill finish operations
    • Developed business relationships with innovators to evaluate devices: patches, needle-free, reconstitution syringes, intra-nasal.
  6. -
    BioPharma Innovation Consultant, Self Employed

    Sponsored by World Health Organization (WHO) to present at consultation meetings on measles-containing vaccines. 

    Consulted with stakeholders developing micro-array patches.

Proudest Accomplishment

My contributions toward the prevention of vaccine preventable diseases, notably polio eradication.

Experience Highlights

  • Operationalization of Canada's Biologic Manufacturing Centre

Interests

  • Cell and Gene Therapy
  • Public Health, Vaccines
  • Innovation

Skills

  • Public Speaking
    8
  • COMBINATION DRUG PRODUCTS
    13
  • Project Management; Six Sigma
    16
  • QUality
    20+
  • Leadership
    20+
  • BioPharmaceuticalmanufacturing
    20+

Location

Toronto, Canada

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