Biopharmaceutical GMP and Quality Manager and Consultant in Canada

Technical Consultant #1692


Expertise

  • Over fourteen years in the Canadian life science industry specifically in biopharmaceutical GMP development and manufacturing.
  • Directed major operational departments including quality assurance, quality control, validation, operations, process development and project management.
  • For start-up company established operational departments, internal business systems, annual budgeting, personnel management and mentoring, contract estimation, contract negotiation, contract management and quality oversight, all within the highly regulated GMP manufacturing environment.
  • CMC commercial portfolios, clinical trial phase biotherapeutic manufacturing and development programs.
  • GMP and biopharmaceutical development and manufacturing principals.
  • Analytical validation specialist skilled at forming teams, supervising validation specialists, equipment validation and hosting corporate and regulatory inspections.

Experience

Undisclosed Company, 2009 - Present

  • As Director of the Office of Project and Process Management for a Canadian biopharmaceutical company for the manufacture, purification and packaging of high-quality biological therapeutics.
  • Responsible for forming, monitoring, coordinating and leading multiple Technical Project Teams to ensure that all contract client projects are consistently developed, scheduled, budgeted, monitored and executed according to the work-plan, timelines and agreement.
  • Coordinating with the Business Development Contract Acquisition Team to provide cost models and quotes for contract development and manufacturing projects.
  • Worked with process development to establish the protein expression purification work-plan leading to successful scale-up and GMP manufacturing of contract biologics.
  • Develop and lead external projects for site transfers, process development, process scale-up, GMP manufacturing and fill/finish biologics programs.

QSV Biologics Ltd., Edmonton, Alberta, Canada, 2002 - 2009

Director, Project Operations

  • Director of an international GMP biologics contract manufacturer for mammalian cell culture and microbial fermentation provided services for the production of protein therapeutics for pre-clinical to Phase III human trials and early commercial supply.
  • Oversaw project management plans, strategies, tools, processes and training; and mentoring project managers on the effective use of processes and relationships with operational group heads to deliver client contracts.
  • Through formal reporting, managing of projects and process development and senior scientific staff, deployed to deliver development and manufacturing services.
  • Overall responsibility for the Process Development department including resource management and allocation.
  • Supported the Business Development department in all aspects of contract progression including technical assessments, margin analysis, preliminary estimation, contract negotiation, drafting, progression and closing, and overall change order management.
  • Member of the senior management team with contribution to key site visits and responsible for future strategic planning initiatives of the company.

Manager, Projects & Process Development

  • Operational management of the process development department consisting of 18 scientists deployed for the development of new recombinant protein therapeutics.
  • Responsible for the process development plan including fermentation, recovery and purification through to scale-up and GMP manufacturing.
  • Responsible for the day-to-day management of client contracts to the agreed statement of work.
  • Provided assistance to scientists during early scouting, proof-of-concept and optimization experiments to ensure process and contract targets are achieved.
  • Responsible for the analytical development program including identifying key assays, managing technology transfer and ensuring successful establishment of the assays in the laboratory to support GMP manufacturing and product release.
  • Responsible for providing technical evaluations and laboratory assessments of novel and emerging technologies that may have an impact on streamlining future contract deliverables or additional capability.

Manager, Quality Control

  • Operational management of the QC department consisting of nine (9) analysts responsible for raw material testing, in-process analysis and final product release testing.
  • Organized analytical support for manufacturing campaigns and internal environmental and utility monitoring programs.
  • Directed validation activities for in-process and final product release assays.
  • Facilitated the transfer and qualification of methods from external laboratories.
  • Managed CRO contracts to time lines and deliverables.

Manager, Quality Assurance

  • Recruited, trained and mentor of a QA team focused on regulatory compliance for the GMP manufacture of bulk biologic Active Pharmaceutical Ingredient (API).
  • Operational management of the QA department consisting of five (5) associates and ultimate oversight over the quality systems.
  • Established and continually improved corporate Quality Systems in support of GMP manufacturing and corporate directives.
  • Lead regulatory (HPFBI and European qualified person), client audits and ensure timely close out of all quality related issues.

Cangene Corporation, Winnipeg, Manitoba, Canada, 2001 - 2002

Supervisor, of Analytical Validation

  • Supervised analytical validation activities for international GMP organization focused on the core businesses of hyperimmune products, biotechnology products and contract manufacturing.
  • Supervised validation specialists for the support of analytical validation including equipment and instrument validation, software validation, method transfer, method qualification and method validation according to current regulatory guidance and ICH standards.
  • Managed analytical validation projects for clinical and commercial pharmaceutical and biologics products.
  • Represented the company with respect to analytical validation during regulatory inspections (USFDA, HPFBI, MHRA, etc.) and contract manufacturing client audits.

Quality Control Analysis

  • Performed in-process, final product and stability analysis of pharmaceutical and biologic products using industry standard assays (HPLC, electrophoresis, TOC, spectrometry, ELISA, FT-IR, particle size).
  • Performed raw material sampling and testing according to compendial and validated methods for the release of materials for manufacturing.
  • Responsible for the development, optimization and validation of methods received from research and development groups and external contract manufacturing clients.

EnviroTest Laboratories, Winnipeg, Canada, Environmental Laboratory Analyst, 1996 - 2000

  • Analysis of trace level components in a wide range of matrices for environmental regulatory agencies, environmental consultants, power companies, major agricultural chemical companies, the petroleum industry, the pulp and paper industry and chemical companies.

Honors & Publications

Credentials

  • BioProcess International Biopharmaceutical Training Conference.
  • International Pharmaceutical Academy Conference on Development and Implementation of Corrective and Preventative Action Systems (Toronto, Ontario, Canada).
  • Institute of Validation Technology Conference on Cleaning, Process and Method Validation.

Education

  • B.S. Biology and Biochemistry, University of Winnipeg, Manitoba, Canada
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