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ARIES COMMUNICATIONS GROUP INC. Nov. 2001 - Present
· Provide technical expertise in pharmaceuticals, medical devices, ISO, and cGMPs
SCICAN, A Division of Lux & Zwingenberger
Manager, Quality Assurance Jan. 2000 - Nov. 2001
· Managed the Quality Assurance Department of SciCan.
· Chaired the management review meetings of the quality system and ensured the appropriate follow-up of resulting action items.
· Managed the Quality Control Laboratory (four quality engineers direct reports).
· Improved incoming material quality through the introduction of vendor qualification programs.
· Management and continuous improvement of the quality system.
· Developed and introduced corrective/preventive action procedures within the quality system that resulted in substantial product/process improvements and defect prevention, thus leading to an increase of corporate profits.
· Participated in and provided direction to multi-functional product development teams.
· Supervised internal quality audits.
· Coordinated company wide internal quality training programs.
· Provided continuous mentoring of manufacturing and R&D departments to ensure the introduction and maintenance of quality principles in those operations.
· Acted as management representatives during 3rd party quality audits.
JOHNSON & JOHNSON
Divisions: Ortho-Pharmaceutical (Canada) Ltd., Ortho-McNeil Inc. & Janssen-Ortho Inc.
Manager, Process Development 1994 – 1999
· Headed significant product and process improvements to the existing medical device manufacturing line, including automation, increase in efficiency, environmental and ergonomic improvements.
· Provided expert input to technical committees charged with the development of new international ISO quality standards for medical devices.
· Directed, coached, developed, supervised and managed cross functional teams of scientists and engineers of industry and academia, resulting in the completion of all projects on-time and within budget by effectively delegating project responsibilities.
· Performed regular presentations to company president and management board to report on departmental performance and to justify the direction for future developments.
· Implemented challenging training / development / open communications programs that enabled staff to maximize their contribution towards corporate goals while increasing job satisfaction.
Manager, New Product Development 1989 – 1994
· Headed multi-million dollar new product development initiatives resulting in patented medical devices and associated manufacturing processes and in commercial technology transfer to Johnson & Johnson affiliates.
· These technologies yielded 7 U.S. and 70 international patents.
· Overall Project Management of R&D initiative, that resulted in the development of patented medical devices.
· Provided direction into pilot plant design for the development of synthetic condom technology.
· Developed and implemented a departmental structure and performance goals that resulted in the fulfillment of corporate targets well within the established guidelines.
· Conducted international negotiations in Japan, Germany, and Brazil that forged close alliances with suppliers and resulted in substantial quality improvements for medical devices.
· Communicated on a regular basis with Johnson & Johnson affiliates worldwide to obtain new product requirements and arranged for transfer of resulting technologies.
Product Development Chemist 1983 – 1989
· Created technical support structure for an anti-viral cream, including validated methods for human serum and dosage form analysis, drug compound characterization, commercial scale-up, stability.
· Developed chemically resistant product formulations and natural rubber latex films with substantially increased tear resistance, resulting in some of the above mentioned patents.
· Development and review of raw material and finished product specifications.
Quality Assurance Chemist 1976 – 1983
· Chemical and physical analysis of raw materials and finished products.
· Developed validated analysis methods for the quantification of drug compounds in finished products using state-of-the art instrumentation techniques including HPLC, TLC, GC, AA etc.
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EDUCATION / PROFESSIONAL DEVELOPMENT
· Professional Engineer, Higher Federal Professional School and Research Institute for Chemical Industry, Vienna, Austria.
· ISO 9000 Quality Systems Auditor, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices, manufacturing excellence seminars, international validation conferences, Six Sigma Business Processes.
· Advanced facilitation, coaching, executive communications, advanced presentation skills.
· Project management, business report writing, statistical data interpretation, document control for quality systems, high degree of computer literacy with major software packages (Microsoft Office)
· Finance for non-financial Managers.
· Solid Systems course at University of Wisconsin (Dr. Jens Carstensen), FDA quality systems regulations
CORPORATE ACHIEVEMENT AWARDS
Ortho Pharmaceutical (Canada) Ltd. - President’s Award for Technical Achievement
(This award was only presented five times during the history of the company.)
TECHNICAL PAPERS AND TEACHING EXPERIENCE
· Technology Transfer (University of Wisconsin, Department of Pharmacy)
· Developments in the Integrity Testing of Condoms (University of Maryland / U.S. FDA conference)
· Application of the Taguchi method to the statistical process development (Johnson & Johnson Quality Systems Conference, San Juan, P.R)
· Lectures at Seneca College and Ryerson Polytechnical University: Introduction to High Performance Liquid Chromatography
PROFESSIONAL ASSOCIATIONS
· Pharmaceutical Sciences Group
· Association of the Chemical Profession of Ontario
INTERESTS AND VOLUNTEER WORK
· Computers, Reading, Skiing, Tennis, languages (German, written French)
· Acted as judge at the Southwestern Ontario Undergraduate Student Chemistry Conference (University of Guelph)
· Successfully lobbied the Austrian government for the implementation of a revised Austrian Citizenship Act (Initiative co-signed by Magna chairman Frank Stronach)
· Led the Canadian delegation of the Standards Council of Canada (SCC) at the Technical Committee meetings in Kuala Lumpur, Malaysia for the introduction of a new international standard for mechanical contraceptives.
REFERENCES
· Available upon request
