Main area of expertise is in vaccine and biologics product development, clinical manufacture, clinical supplies and industrialization.

Career History:

Sanofi pasteur Ltd.  2015 – 2022

Toronto, Ontario, Canada

Role: Vice-President, Product R&D Global, Global Head of Product Reseach and Development. 

Principal Responsibilities:

Responsible for process and analytical development leading to Phase I and Phase II clinical material manufacture and delivery to the clinical trial sites to support global new vaccine portfolio.  Leading a group of approximately 600 globally.

Sanofi pasteur Ltd.  2014 – 2015

Toronto, Ontario, Canada

Role: Associate Vice-President, R&D

Principal Responsibilities:

Responsible, as Global Program Lead, for the activities related to the improvement of the robustness of existing processes and analytical methods and elements of the de-risking plan linked to our processes.  Lead, coordinate and support the strategy definition and implementation of the action plans for antigen process optimization, analytical methods and a range of risk mitigation projects.

Sanofi pasteur Ltd.  2009- 2014

Toronto, Ontario, Canada

Role: Associate Vice-President, Bioprocess R&D North America

Principal Responsibilities:

Provides leadership for a Department of over 95 people and contributes to the growth and profitability of the Company through the overall direction, administration and management of all activities related to the development of new or improved products supporting the NV portfolio.  Main responsibilities include development of innovative manufacturing processes to provide material for preclinical and  clinical studies up to phase III.  In addition, the transfer of these processes to Manufacturing Technology for implementation in Industrial operations.

Member of the R&DOC, CMC Site Management Committee, RDLT, PSF, PCD SMT, Joint Management Labour Committee (JMLC), North American R&D Hub. 

Accomplishments:

• Successful implementation of new filling line

• Successful implementation of R&D Transformation within BRD.

• Continuous achievement DKM’s and PKM’s (>90%) in support of NV portfolio.

• 100% success rate in delivery of clinical material to clinical trial sites to support 10 clinical trials.

• Member of the site management negotiation committee and successfully achieved labour union contract on-time, on-budget and for the first time a 4 year term.

• Achieving and maintaining a high quality Department with focus on compliance and risk mitigation.

• Continuous monitoring of quality and performance metrics and development of a performance dashboard.

• Success development of staff throuth development plans, talent management and succession planning.

Sanofi pasteur Ltd.  2001- 2009

Toronto, Ontario, Canada

Role: Associate Vice-President, Process Development

Principal Responsibilities:

Provides leadership for a Department of over 70 people and contributes to the growth and profitability of the Company through the overall direction, administration and management of all activities related to the development of new or improved products supporting the NV portfolio.  Main responsibilities include development of manufacturing processes to provide material for preclinical and  clinical studies up to phase III.  In addition, the transfer of these processes to Manufacturing Technology for implementation in Industrial operations.

Member of the Site Management Committee, RDLT 

Accomplishments:

• Implementation of new Process Development Building (Building 93) in 2003.

• Implemented a number of initiative to enhance performance leading to continuous achievement (>90%) of PKM’s and DKM’s to support NV portfolio.

• Implemented a number of inititatives to ahieve quality metrics, in particular non-conformance management.

• Supported the successful global implementation of a Clinical Supply Chain process leading to >90% on-time global delivery of clinical trial material.

• Implemented process and templates to monitor and track metrics/KPI’s

Aventis Pasteur Ltd. 1998-2001

North York, Ontario

Role: Director, Bacterial Development

Principal Responsibilities:

• To provide leadership to Bacterial Fermentation Platform locally, and globally from 1999, with appointment to Corporate Platform Leader role.

• To support project plan definitions and provide scientific expertise and guidance to projects and then to manage the resources and activities necessary to meet project and platform milestones.

Accomplishments:

• Project leader of recently completed $6 million construction and validation of new Bacterial development cGMP facility (brought in on schedule at a cost saving of 5 million dollars compared to the initial tender).

• As corporate platform leader, defined core competencies for the platform and global centers of expertise, led in the definition of a global competency development plan, investigated and evaluated key new technologies that are now being applied to the PspA project, and developed indicators of performance for global and local use.

Pasteur Merieux Connaught 1995-1998

North York, Ontario

Role: Manager, Bacterial Development

Responsibilities:

• Manage group of 14 people and operational budget of over $2 million.

• Manage the development and clinical manufacture of bacterial products

• Responsible for development and optimization of bacterial fermentation processes.

• Responsible for development and optimization of purification processes

• Development project leader for Otitis media project.

• Development project leader for BCG projects

Accomplishments:

• Development and optimization of recombinant E. coli fermentations

• Clinical manufacture of Otitis media vaccine

• Optimization, scale-up and clinical manufacture of BCG-vaccine and BCG-immunotherapeutic

• Prepared SOP’s and BPR’s for clinical processes

• Interaction and liaisons with Q.A., R.A., Q.C., Research, Clinical and Medical Affairs

Connaught Laboratories Limited 1994-1995

North York, Ontario

Role:  Development Scientist, Development Division

Accomplishments:

• Initiated downstream processing for clinical lot production of PIV-1 and PIV-2

• Supervised downstream scale up process, site selection, prepared clinical production

• Prepared required SOP’s and BPR’s

Labatt Brewing Company, London, Ontario 1986-1993

 Role: Principal Scientist, Research Department (1989-1993)

• Managed and directed the fermentation and yeast biochemistry research group activities

• Manager of three post-doctoral fellows, two visiting scientists, three research assistants, one Ph.D. student, three contract employees and co-op students