General Experience

• Dr. Fitzpatrick has a wide range of experience in the biological, pharmaceutical, chemical and petrochemical process industries in a variety of functions involving R&D, process technology development and plant design and operation.
• The primary emphasis of his academic training and industrial experience has been in biochemical and pharmaceutical engineering.

Education

• University of Manchester, England
  Ph.D., Biochemical Engineering, 1975; Thesis Title: "Kinetics of Fungal Amylase."
• University of Manchester, England
  M.Sc., Biochemical Engineering, 1973.
• University of Manchester, England
  B.Sc., Chemical Engineering, 1972.

Awards

• Dista Prize
  Biochemical Engineering, University of Manchester, England, 1972.
• Presidential Green Chemistry Award
  Environmental Protection Agency, June 1999.

Registration

• Chartered Engineer, Member of Institution of Chemical Engineers, UK.

Languages

• English, French and German — read and write

Publications and Patents

• "Food from Wastepaper", D. E. Brown and S. W. Fitzpatrick; Proceedings of 6th International Symposium on Food Technology, Weybridge, 1975.
• "A Structured Model for the Kinetics of Fungal Amylase", D.E. Brown and S. W. Fitzpatrick, 1st European Congress on Biotechnology, Interlaken, 1978. Published in Biotechnology Letters (1979); vol. 1 pgs. 3-8.
• "Kinetics of Fungal Amylase", D. E. Brown and S. W. Fitzpatrick, 6th Annual Research Meeting, Institution of Engineers, London, April 1979.
• "Co-production of Ethanol and Furfural from Lignocellulose", S. W. Fitzpatrick, ACHEMA 1985, Frankfurt (Session Chairman). Published in Chemische Industries.
• "Biotechnological Enhancement of the Pulping Process", S. W. Fitzpatrick, E. M. Egan (Repligen), C. D. Miserlis (Badger), AlChE Meeting, August 1986.
• "Industrial Applications of Lignase Enzymes", S. W. Fitzpatrick, ACS National Meeting, Anaheim, CA. Sept. 1986.
• "Meeting CGMPs for Bulk Bioparenterals", S. W. Fitzpatrick, J. Waggett and A. Ma'ayan, AlChE National Meeting, November 1989, San Francisco. Published in Chemical Engineering Progress, Dec. 1990.
• "Designing High Containment Research and Containment Facilities for Biotech and Pharmaceutical Processes”, S. W. Fitzpatrick, J. Waggett and A. Ma'ayan; presentation to the Massachusetts High Technology Council, Milford, MA, Oct. 24, 1989.
• “Clinical Production Facilities-Delivery, Design, Operating and Regulatory Considerations”, S. W. Fitzpatrick, Scott W. Mackler Pharmaceutical Technology, Sept. 1995.
• U.S. Patent 4,897,497 Lignocellulose Degradation to Furfural and Levulinic acid
• U.S. Patent 5,608,105 Production of Levulinic Acid from Carbohydrate-Containing Materials

George D. Combes, PE

Manager, Process Engineering

General Experience

• Mr. Combes is a registered professional engineer with over 24 years of experience in the execution of complex, multi-system process facilities for a wide variety of industries, including biotechnology, pharmaceutical, specialty chemical, bulk chemical, and semiconductor industries.
• He has been a lead process engineer and project consultant on several biotechnology projects involving both cell culture and bacterial fermentation. He was responsible for the process design of all related systems in these facilities, including fermentation, downstream processing, fill finish, and GMP utilities. One of these projects required many systems to meet BL3+ containment and handling procedures for a spore forming organism. His other pharmaceutical projects also include API systems using both conventional reactors and hydrogenation systems. These projects required great attention to detail in regards to handling highly toxic and explosive materials.
• Mr. Combes has over 13 years experience in the design of high purity/purified water treatment and distribution systems and is familiar with the design requirements and preferences of both the pharmaceutical and semiconductor manufacturing industries.

Education

• Northeastern University
  B.S., Chemical Engineering, 1982
  With Highest Honors

Registration

• Professional Engineer, New Hampshire

Languages

• English

Publications and Patents

• AICHE Conference, Pretreatment Regulator Requirements, 1992
• McGraw-Hill, facilities Engineering and Management Handbook, 2001

Richard R. Senecal, A.I.A.

Vice President, Architectural Services

General

• Mr. Senecal is NCARB Certified and is a Licensed Architect in multiple states with the ability of being licensed in any of the remaining states as required.
• Mr. Senecal is responsible for completing the building and life safety code reviews for all facility developments as well as completing the facility design for the layout and arrangement of the various processing suites. Mr. Senecal works with the process engineers in completing the layout and arrangement of the proposed process equipment contained within each area of the facility.
• Mr. Senecal has over 20 years of experience in the design, construction and management of various sized cGMP production and processing facilities under FDA, USDA and other national and international regulatory agency requirements.

Education

• Wentworth Institute of Technology, Boston, MA: Bachelor of Science,
  Architectural Engineering Technologies, 1985
• Wentworth Institute of Technology, Boston, MA: Associate Degree,
  Architectural Engineering Technologies, 1982

Registration

• NCARB Certification No.: 58,851
• American Institute of Architects
• Current Architect Registrations: Connecticut, New York, Massachusetts, Virginia, Maryland

Ricardo Cortes

Commissioning Manager / Sr. Process Engineer

General Experience

• Mr. Cortes is responsible for the project management, process design, commissioning and start-up for production facilities in the biotechnology, food and consumer products, and chemical industries.
• Mr. Cortes is a chemical engineer with more than 30 years of professional experience in the biotechnology, food, consumer products, fine/specialty chemicals, and petrochemical industries. He has been involved in the design, construction, validation and operation of CGMP facilities; facility programming; feasibility studies; construction; and plant startup. Mr. Cortes offers experience in project management, scheduling, cost control, and quality assurance.

Education

• Instituto Politecnico Nacional (Mexico City, Mexico)
  B.E., Chemical and Process Engineering, 1971.

Harold P. Schaefer, Ph.D.

Director of Validation Engineering

General Experience

• Dr. Schaefer has over 27 years experience in the medical product industry. He is a validation specialist with a microbiology background and broad multi-disciplinary expertise in validation, sterility assurance, and the GMP environment. He has extensive experience with autoclaves and other types of sterilization.
• Dr. Schaefer is responsible for project leadership and for the preparation and execution of validation protocols.

Education

• Ph.D. (Microbiology), University of Connecticut
• B.A. (Bacteriology), University of Connecticut
  High honors and distinction in Microbiology, Phi Beta Kappa

Publications

• Jacobson, Kevy, Thorne, Goldman, Blasetti, Smith, Schaefer., "Microbial Challenge of the Haemonetics V-50 Outside Seal Bowl". Transfusion, 30:146-149, 1990.