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Resume of SCM
Consultant
EXPERTISE AND SERVICES
Cleanroom, Environmental Assessment Expert ConsultantExpertise in cGMP cleanroom design and controlled environment applications, contamination control consultation and environmental assessment, troubleshooting, and assessment for FDA validation of critical facilities.
This KKAI Associate also specializes in new product introductions for the contamination control marketplace, conceptual design phase for projects in the life sciences (human blood products-based therapeutics and autologous cell transplant), and spinal nerve cell therapy.
This associate offers specific expertise relative to biotechnology projects for tissue culture applications and for the manufacture of therapeutic proteins via microbial expression systems and mammalian cell culture, anti-cancer therapeutics, strategic marketing and product development plan for a new technology for ELISA (enzyme linked immunoassay) testing, cleanroom compatibility testing, merger and acquisition advisement, outsourcing services and industrial sales and marketing consultation including customer retention strategies, corporate management, and project planning.
Extensive knowledge regarding basis of design development, commercialization of new products, applications for process isolation and mini-environments, construction claims arbitration, vendor, contractor identification and qualification, RFP, RFQ preparation, project financial justification, site selection services and third party design reviews, modular design & construction, clinical production facilities, and delivery.
Additional experience includes design, operating and regulatory considerations, design of production facilities for cell & gene therapy, project planning and basis of design for cleanrooms, advantages of modular cleanrooms, barrier isolation technology, life sciences cleanroom application improvement, environmental monitoring
PRINCIPAL INDUSTRIES SERVED
Biotechnology, Chemicals, Environmental, Food Processing, Health and Beauty Aid Products, Medical Devices and Equipment, Packaging,
EDUCATION
M.B.A., University of Houston
B.S., Mechanical Engineering, Rensselaer Polytechnic Institute
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing project management, contamination control consulting, cGMP cleanroom design and controlled environment consulting, troubleshooting, assessment and corrective actions for FDA validation consulting and related expertise for a wide variety of clients.
Speak to this experienced, world-class expert now.
- Call (317) 735-7490
- E-mail scm@rapid-response-consulting.com
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Contamination Control Industry Specialist, Environmental Assessment Specialist, Consultant, Expert
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Specialized in contamination control industry services including cGMP cleanroom design and controlled environment applications, troubleshooting, assessment and corrective actions for FDA validatable critical facilities, new product introductions for the contamination control marketplace, merger and acquisition advisement, outsourcing services and industrial sales & marketing consultation including customer retention strategies. Led the basis of design (conceptual design phase) teams for projects in the life sciences (human blood products-based therapeutics and autologous cell transplant) and acted as owner representative for a spinal nerve cell therapy center as well as being actively engaged in biotechnology projects for tissue culture applications and for the manufacture of therapeutic proteins via microbial expression systems and mammalian cell culture. Completed a FDA pre-construction review package for a Phase III/Commercial launch facility for the production of an anti-cancer therapeutic.
Authored a strategic marketing and product development plan (“stage/gate” process) for a revolutionary new enabling technology for ELISA (enzyme linked immunoassay) testing. Provided cleanroom compatibility testing and recommended actions to semiconductor inspection tool manufacturers. Provided on-site consultation to cleanroom contractors performing work at DuPont (semiconductor wafer fab pilot project), Lucent (fiber optics cleanrooms) and at Balaz Labs (airborne molecular contamination laboratories), as well as for a nanofabrication retrofit/expansion facility at Penn State; wrote Cleanroom User Requirements Specifications and Cleanroom Facility Functional Specifications for a major control systems provider.
Provided contamination control consultation and environmental assessment including recommended actions to a number of biotechnology companies, medical device injection molders, and to the world's leading manufacturer of high tech filtration products in support of their "Clean Team" facilities initiatives. Served on the Editorial Advisory Boards of A2C2, the Journal of Contamination Control, American Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract manufacturing, and Pharmaceutical Formulation and Quality. Frequent speaker on the topic of cleanroom design, contamination control, facilities project delivery and cleanroom operations and protocol. Presented at meetings for A2C2, Barnett International, ISPE, PDA, “Cleanrooms” & “Cleanrooms International”, Marcus Evans, and Williamsburg BioProcessing Foundation.
General Manager, Clestra Cleanroom, U.S.
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Participated on team that was responsible for the design, fabrication, installation, and commissioning of the cleanrooms for the Xerox, Canandaigua site (now the new Infotonics Technology Center of Excellence in Canandaigua).
Prior to Clestra Cleanroom was employed by Allied Signal and Union Carbide.
Alpha Therapeutics, Memphis, TN
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Blood Testing Facility. A large number of individual release assays were required to be performed real-time. The facility was the first of its type for this company and for this process and was delivered as a design/build (Clestra). Class 1000 retrofit (suite type layout) to existing laboratory space.
Guilford Pharmaceuticals, Inc., Baltimore, MD
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Potent compound containment facility for clinical trials production of Gliadel wafer (Clestra). The Gliadel wafer is a dime-sized chemotherapeutic agent comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7. mg of carmustine. The wafer is implanted into the cavity created when a surgeon removes a brain tumor and delivers chemotherapy directly to the site of the glioblasta multiforme. Directional laminar flow (Class 100), 100% once-thru air, and negative pressure containment were utilized to provide a fully validatable aseptic containment.
Bioscience Contract Production (Maryland Bio Center), Baltimore, MD
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Designed and built (Clestra) two facilities which were among the first in the US to incorporate unidirectional functional flows for segregation and separation (suite type layout). HVAC system design featured multiple independent units for each multi-product, multi-user suite (upstream and downstream processing). Modular components were used for maximum flexibility; the cleanrooms were suitable for commercial scale microbial as well as mammalian cell production. Special attention was paid to ensuring that large pieces of process equipment, such as reactor processing trains, could be readily moved in or out of the various suites, and every suite was designed to accommodate additional, future contingent process support services. Each suite featured dedicated media preparation rooms, buffer preparation rooms, and clean cold rooms. Class 100,000/Class 10,000/Class 100 Operational.
Collogenesis, Boston, MA
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Clinical Trials facility for collagen production (Clestra). Class 10,000 cGMP rooms (suite type layout) were designed to accommodate large numbers of Baker Class II Type A/B3 biosafety cabinets required for product manipulations. Protection of product was extremely critical as the nature of the clinical procedure precluded any opportunity to practice QC release testing prior to patient injection.
DuPont, Wilmington, DE
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Design and construction of a cleanroom envelope system comprised of 15 separate areas (Bay & Chase) each designated as Class 1000 "boutique fab areas". Facility for development of advanced superconductivity technology with a focus on the acceleration of conductive factors in components for the Department of Defense. Consulting services during design, construction and commissioning to cleanroom design/builder.
ADDITIONAL EXPERIENCE
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Additional Experience
Merck Sharp & Dohme, West Point, PA
Designed and built a 54 room retrofit fast track vaccine facility for production of injectable human vaccine (Clestra). Unidirectional functional flows, flexible HVAC design, and strict attention to cGMP’s provided Merck with a commercial launch facility (Bay & Chase style suites) inside an idle warehouse. Class 10,000/Class 100.
Unigene Labs (Turnkey Calcitonin Production Facility), Boonton, NJ
Participated in the design and turnkey construction (Clestra) of this facility for recombinant therapeutic production from process development through to the commercial phase, including aseptic fill and finish of final formulation. The facility design (suite style) was replicated overseas for sponsor partners. Class 10,000/Class 100.
Kodak Optical Group, Rochester, NY
Steag dye coater tool enclosure (mini-environment) to temperature / humidity of 72 deg F +/- .25 / 50% +/-2% RH. (Clestra) Static charge on polycarbonate blank <100V. Better than Class 100 performance.
Penn State NanoFab, State College, PA
Conceptual design consultation and assistance to engineering firm for retrofit to existing Class 1000 (ballroom) Nanofab to incorporate new SPM tool and expand to add Biohazard Level 2 NanoBIO capability/capacity.
Haskel International, Los Angeles, CA
Owner representative for refurbishment, start-up, test/balance/certify and recommissioning of long idle Class 1000 cleanroom for ultrasonic cleaning of aerospace oxygen system parts. Project included recommissioning of all processes and process equipment, as well as provision of cleanroom operating, gowning, maintenance, and cleaning protocols.
White Oak SemiConductor, Richmond, VA
Furnish 120,000 square feet of Flush Grid (Class 1) ceiling product for fast-track grass-roots wafer fab (Clestra). Large ballroom style cleanroom for fabrication of memory chip wafers.
Robotic Vision Systems, Long Island, NY
Contamination control assessment, cleanroom compatibility testing, manufacturing environmental assessment and recommended actions for WS-1000 wafer inspection tool.
HONORS AND AWARDS
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PROFESSIONAL AFFILIATIONS
Rochester High Tech Business Council
Parenteral Drug Association
ASHRAE
International Society of Pharmaceutical Engineers
International Society for Cell Therapy
Semiconductor Equipment and Materials International
Institute of Environmental Sciences and Technology
US-Israel Biotechnology Council
New York Biotechnology Association
PUBLICATIONS
Numerous publications on topics including Modular Design & Construction, Clinical Production Facilities, Delivery, Design, Operating and Regulatory Considerations, Design of Production Facilities for Cell & Gene Therapy, Project Planning and Basis of Design for Cleanrooms, Advantages of Modular Cleanrooms, Barrier Isolation Technology, Life Sciences Cleanroom Application Improvement, and Environmental Monitoring.
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax