Advanced Barrier Concepts, Inc.
Vice President / Principal Scientist: Co-founded Advanced Barrier Concepts, Inc. to offer direct technical assistance to the pharmaceutical and biotechnology industries on the microbiological aspects and validation requirements for sterile isolator applications. Involvement in over 20 isolator validation projects that have dealt with sterility testing, clinical manufacturing, sterile bulk packaging and high-speed production filling operations. Responsibilities have included project management, validation protocol generation and execution, the drafting of SOPs, and the preparation of final reports. Co-authored two chapters on engineering and microbiological aspects related to isolator sterilization in a 1995 Interpharm book, entitled Isolator Technology. A listing of publications and presentations is attached.
Systems Engineer: Duties included Applications Engineering assignments (as below) plus direct sales responsibility of three AMSCO hydrogen peroxide sterilant generators and a line of flexible-wall isolators for use in sterility testing laboratories. Responsible for providing technical support to customers in the Northeastern United States.
Applications Engineer: Responsible for providing engineering support and project management capabilities to the life science / biopharmaceutical customer for applying hydrogen peroxide gas sterilization to isolation equipment and freeze dryers. Demonstrated technical feasibility of new applications, performed training sessions on the safety and operational aspects of equipment, assisted customers with sterilization validation and operational performance issues, and prepared and presented technical publications for emerging technologies.
American Sterilizer Company
Senior Scientist: Responsibilities included sterilization efficacy testing on Vaporized Hydrogen Peroxide sterilizer development projects, assisted in the testing for and the preparation of regulatory submittals, provided technical support to Marketing and Engineering and gave presentations on VHP sterilization applications in the healthcare marketplace. Also responsible for managing the daily activities of two scientists.
Scientist: Part of a research and development team assembled to rapidly develop a VHP Table-Top Sterilizer. Primary microbiologist responsible for preparing test protocols and performing the biological efficacy tests required by the regulatory agencies. Assisted in the preparation of regulatory submittals and the equipment manual. Regulatory approval was granted for the sterilizer without requests for additional information. Managed the daily activities of another scientist.
Associate Scientist: Assumed the primary microbiological responsibilities for outside research and development contracts and in-house development programs dealing with VHP Sterilization Technology. Also designed, developed and tested concepts for the sterilization and depyrogenation of water and surfaces.
Assistant Scientist: Responsible for conducting feasibility studies on potential liquid disinfectants and sterilants.
- Virginia Polytechnic Institute and State University – Blacksburg, Virginia
Master of Science, Environmental Sciences and Engineering, 1982.
- Gannon University – Erie, Pennsylvania
Bachelor of Science, Biology, 1979.
- U.S. Patent No. 4,648,978: Process for the Continuous Preparation of Sterile Depyrogenated Solutions.
- U.S. Patent No. 4,863,688: Method for Decontaminating Surfaces on or Near Living Cells with Vaporized Hydrogen Peroxide.
- U.S. Patent No. 4,935,371: Sterilizable, Gas Permeable Container for Use in Culturing Living Cells.
- U.S. Patent No. 5,445,792: Optimum Hydrogen Peroxide Vapor Sterilization Method.
- U.S. Patent No. 5,508,009: Optimum Hydrogen Peroxide Vapor Sterilization System.
- American Glovebox Society (AGS)