ISOGEN has brought together top industry engineers, scientist, process architects and regulatory professionals to launch the ISOGEN Engine. Deeply experienced in worldwide scale-up aseptic processing, potent compound manufacturing and the intricacies of regulatory affairs ISOGEN delivers the highest level of strategic planning and implementation skills in the industry.

Isogen’s Leadership

Isogen’s senior management team is comprised of highly talented and determined engineers and scientists who’ve spent their entire careers building toward the realization of Isogen. Their vision is to set a new standard of excellence in the field of sterile processing by practical implementation of the latest technologies and controlling quality through smart process development and a disciplined approach to project management.

Management Team

Les Edwards, MSE CEO: Industry leader in the application of isolation technology

• 16 years of industry experience - current leader of consulting firm in isolation, sterilization, and aseptic processing
• Prior major pharma sterile process engineering (Merck) and equipment R&D (AMSCO, now STERIS) experience
• B.S. Bioengineering, M.S .Technology Management (Penn Eng./Wharton)
• 40+ industry presentations and publications (including 3 book chapters) on aseptic processing, sterilization, and FDA/EU regulations

Austin McDonald - COO: Long-acknowledged expert in aseptic processing

• 18 years of industry experience - current partner in leading consulting firm in aseptic processing
• Former director of barrier technology John Brown Engineering (Aker Kaverner)
• Holds numerous patents for aseptic processing equipment and devices
• Teaches graduate level Pharmaceutical Project Management at Stevens Institute of Technology
• 40+ of industry presentations and publications on aseptic processing, sterilization, and GMP Project Management

Robert Serra - VP Technical Development: Technology transfer and scale-up expert.

• 30+ years of industry experience - J&J, Schering Plough, Novartis
• Expert in scale-up of aseptic processes, including extensive background in potent compound manufacture
• Worldwide experience supporting J&J facilities

Robert Roy, M.S.,P.E.- Director of Manufacturing: Major pharma and contract manufacturing.

• 20+ years of industry experience - former Bristol-Myers Squibb corporate engineering associate director and other senior technical positions in Production, Engineering, and quality
• Recently completed design and start-up of Bristol-Myers advanced aseptic processing facilities in Puerto Rico

Stephen K Tingley - Director of Business Development:

• 25+ Years of industry experience in providing technical sales and client support.
• 18 yrs downstream fill and finish, membrane filtration and validation and development of single use strategies with Millipore.
• Upstream knowledge including.
• Fermentation technology and cell culture process development.
• Purification application of ultrafiltration and chromatography.
• Many industry presentations and published articles.