Our staff members are energetic, dedicated to client service, and diligent in their approach to solutions. Supplementing the technical staff, in the role of company leadership, is a group of Quality professionals who also have deep operational and regulatory compliance experience to meet our clients’ every challenge.
Bill founded VaLogic in 2001 to fulfill a need for focused expertise in the design and qualification of cGMP-compliant biopharma facilities, utilities and equipment. Over the years, he has broadened VaLogic’s service offerings to help over 300 biopharma companies advance their development and commercialization of life-enhancing therapeutics.
In addition to being the principal of the firm, Bill’s role includes providing consultation for qualification and operation life science facilities to support global projects in research, biopharma and gene therapy industries. He is a subject matter expert in several areas, including bioprocess systems, sterile product manufacturing, and starting-up cGMP-compliant facilities. Bill has also been a pioneer in the application of Integrated Commissioning and Qualification (ICQ).
He is a member of the International Society for Pharmaceutical Engineering (ISPE), Parental Drug Association (PDA), Institute of Environmental Sciences and Technology (IEST), as well as a member of the SciTech Business Forum (SBF) and is an active volunteer Board Member for the Boys and Girls Club of Frederick County (BGCFC).
Mark CroweDirector of Calibration and Mechanical Services
Mark has over thirty years of experience in the electronics, computer systems, and calibration fields. Mark has performed calibrations on both mechanical and electronic devices. They range from phase matching, amplitude tracking and troubleshooting micro miniature devices in a clean room environment to a wide variety of both R&D and cGMP laboratory equipment. Mark is also responsible for maintaining the traceability of all VaLogic standards to NIST.
Mark also has experience in the construction and controls of walk in environmental rooms, refrigerators and freezers. Responsible for verifying that the system controls and wiring are correct. Mark also assists in the validation of these units, as well as various other cGMP equipment.
Kevin McGough, PhDHead of Software as a Service
A biotechnology informatics and compliance specialist in value-integrated process automation, and quality systems design and deployment, Kevin comes to VaLogic with extensive experience in numerous aspects of the pharmaceutical industry.
While at a leading clinical stage 2/3 vaccine developer under going rapid expansion, Kevin directed the design and construction of information and automated validation systems with full service IT/IS support for 700 domestic, international and remote personnel.
At a global-leading biotechnology development enterprise, Kevin built a world-class Operations Information Systems department. He also led information system integration through all system lifecycle stages, specializing in computer validation, and creating communities of practice across the lab, manufacturing, and supply chain to assure quality and regulatory compliance.
Jeff WellsHead of Corporate Development
Jeff has over 25 years of CMC-related experience in vaccines, gene therapy, pharmaceuticals, and the medical devices industry. His functional experience ranges from development and day-to-day management of QA/QC operations to remediating quality systems at firms of various sizes. Prior to joining VaLogic, Jeff held various quality management positions at Baxter Healthcare Corp and other emerging biotechnology companies.
Jeff specializes in developing and deploying quality systems required to support commercialization of new products, manage compliant and efficient operations, or remediate significant regulatory compliance deficiencies. Over half of his career has been spent directly or indirectly overseeing Quality activities in firms developing products such as AAV-based gene therapy candidates to several vaccines for polio, smallpox, anthrax, and pandemic influenza.
In a management consulting capacity, Jeff has advised clients in key focus areas from optimizing their vaccine portfolios, implementing product development tools, optimizing medical device R&D organizations, integrating two previously autonomous biopharma quality divisions, to remediating deficiencies in quality systems/culture at two separate medical device companies under consent decree with FDA.
Jeff earned a Master of Business Administration from the Robert H. Smith School of Business at the University of Maryland. He received his Bachelor of Science in biochemistry from Texas Tech University.