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Expert in Pathogenic Organisms: Biology and Ecology; Biosciences Product Development
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Expert has a broad background in the biological and ecological sciences especially as related to pathogenic organisms including their identification, diagnosis, control and mitigation.
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Expert notes that the biology and ecology of pathogenic organisms is greatly influenced by climate which dictates environment which influences the biology/ecology of host - pathogen relations. Environmental issues surrounding the consequences of global climate change compounded by human activities on ecological systems has been a part of Expert's studies for the past 25+ years. Expert has founded a research corporation to study the consequences of climate change and compounding human activity on ecological systems and has presently in development a 13 part documentary series which discusses pathogen related issues to health and presents research being done today to address these concerns.
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Expert has spent ten years as partner in two OEM diagnostic companies for development and manufacture of enzyme immunoassays (EIA) for medical, veterinary, food and water quality and environmental testing products. The majority of the product line was used in the medical diagnostic laboratory for the determination of medically important organisms both parasitic and bacterial (e.g. E. coli O157). In his consulting to industry, Expert's primary responsibilities covered addressing client concerns for removal or disinfection of medically important microbial organisms (e.g. filtration of pathogenic organisms by use of filtration in personal water filtration devices). Expert also consulted to a major metropolitan city for the development and implementation of that city' response program to biological terrorism. He also developed, established and maintained oversight of local community emergency response programs of which responding to health situations presented by medically important microbial organisms (pathogens) was of significant importance.
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He has worked as an industry consultant for product development, materials / vendor selection, oversight of testing to regulatory guidelines, basic biology / ecology of pathogenic organisms and correctness of regulatory submissions and marketing literature for companies developing products which address the control or reduction of microbial contaminants (e.g. water filtration, unine collection and blood borne pathogens).
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Microbial life forms have been a lifelong personal, academic and professional interest for Expert. His primary interest has been in the biology and ecology of pathogenic organisms, the evolutionary relationship to host(s) and their environment and the ecological system that supports the relationship. He is well versed in the biology and ecology of microbes and takes a 'microbialcentric' (i.e. from the microbe's point of view) view of the subject. Expert has worked with developing diagnostic products (enzyme immunoassays) and products for the control and reduction of microbes addressing infection control (e.g. personal water filters).
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Mycological organisms as pathogens are relentless in their abilities to cause disease. Understanding their biology and ecology is key to their control as a pathogen prior to infection. Expert is interested in research being conducted in mycological control methodologies. He is interested in further research on fungi regarding their potential as natural medicinals (nutraceuticals) and their use in converting cellulose biomass into biofuels.
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Expert is trained primarily in classical parasitology, parasite taxonomy and identification. Of particular interest has been the host - parasite relationship and the influence of environment on the evolution of the relationship. He was previously a partner in two diagnostic development and manufacturing companies which focused mainly on enzyme immunoassays for parasitic infections: Protozoa (Giardia, Cryptosporidium, E. histolytica), Helminths, Cestodes, Trypanosomes, viruses. He has been an industry consulting for personal water filtration products addressed removal and disinfection of these and similar pathogenic organisms. Expert also consulted for product development of medically oriented products which removed or prevented microbial growth or parasitic exposure (e.g. urine collection bags, personal hygiene travel accessories).
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Expert was previously a partner in two diagnostic development and manufacturing companies which also developed and manufactured enzyme immunoassays for parasitic viruses (e.g. Rotavirus). He is interested in the abilities of viruses to influence non-pathogenic strains of microbes into acting as pathogenic strains and their resulting pathology.
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In his professional career, Expert has had the unique pleasure of assisting in taking a small diagnostic development and manufacturing company from start up to successful market competitor. As a company principal, Expert helped take the company from one research bench in an old Quonset hut to a facility consisting of four custom build-out suites. His product line consisted of immunoassays for the determination of medically important pathogens though company technologies were also used to establish a sister company of products for food, water and environmental quality testing. Expert's interests in these companies were sold in 1996/98 respectively and he has been active as an industry consultant for several years. In his consulting to industry, he has provided technical information and analysis, assisted with product research, development and testing to regulatory guidelines, developed and implemented manufacturing and quality control processes and writing all accompanying Standard Operational Procedures (SOPs per cGMPs). He has supervised employee training for production, quality control and safety as well as marketing and sales. He has also acted as a regulatory interface between client and regulatory agency on regulatory matters (FDA, EPA, USDA). Expert has worked in the field, in the research and clinical laboratory, in the manufacturing facility and in the market place. His professional experiences cover aspects ranging from materials research & product development, vendor selection and qualification, inventory and material control, in house manufacturing, product evaluation and quality control, maquiladora contract manufacturing and the in vitro culture of pathogenic strains. This would also include employee training and safety (including the development of all documentation associated with the above areas), regulatory affairs [including inspections (FDA, EPA, USDA)] and marketing (OEM, CSR, trade shows, & sales) from start up through scale up of both product line and facility. In addition, he has attended a number of professional seminars related to management and regulatory affairs, presented at trade shows and meetings and taken numerous personal and professional development courses.
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Expert has worked in the areas of in vitro diagnostics, Class 1 medical products and water filtration where the primary emphasis was on pathogen disinfection, reduction or control. He has work under regulatory quality control guidelines (FDA, EPA, USDA for medical, veterinary, food and water quality, and environmental products. He has developed quality manufacturing principles and procedures for both his own companies and for clients. Manufacturing processes were developed under Good Manufacturing Practice (GMP) guidelines and GMP Quality Control validation principles were implemented and practiced at all levels. Expert has been subject to state and federal government regulatory agency inspections (and passed with high marks).
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Medford, Oregon.
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Degree |
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Subject |
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Institution |
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1979
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B.A.
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Biology / Chemistry
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University of Northern Colorado
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| Years |
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Employer |
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Title |
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Responsibilities |
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2007 to 2008
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Self-employed
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Consultant
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Consultant to the biosciences industry for product R&D, operations development, manufacturing process development and validation and regulatory affairs.
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2006 to 2007
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Nutraceutical research laboratory - confidential
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medical scientist (nutraceutical research)
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Expert conducted research demonstrating affects of botanical extracts on human immune system (WBCs). Expert also directed oversight of laboratory operations.
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2004 to 2006
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national broadcast syndicator - talk radio
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Producer - science programming
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Expert developed show / topics and produced content, arranged for scientific guests for nationally syndicated science based talk show hosted by internationally recognized scientist.
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1996 to 2004
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PATHOGENIX
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Owner / Independent Industry Consultant
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As consult to industry, Expert provided technical information and analysis, assisted with product research, development and testing to regulatory guidelines, developed and implemented manufacturing and quality control processes and writing all accompanying Standard Operational Procedures (SOPs per cGMPs). Expert supervised employee training for production, quality control and safety as well as marketing and sales. Expert also acted as a regulatory interface between client and regulatory agency on regulatory matters (FDA, EPA, USDA). Expert has worked in the field, in the research and clinical laboratory, in the manufacturing facility and in the market place. Expert's professional experiences cover aspects ranging from materials research & product development, vendor selection and qualification, inventory and material control, in house manufacturing, product evaluation and quality control, maquiladora contract manufacturing and the in vitro culture of pathogenic strains. This would also include employee training and safety (including the development of all documentation associated with the above areas), regulatory affairs [including inspections (FDA, EPA, USDA)] and marketing (OEM, CSR, trade shows, & sales) from start up through scale up of both product line and facility. In addition, Expert have attended a number of professional seminars related to management and regulatory affairs, presented at trade shows and meetings and taken numerous personal and professional development courses.
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1993 to 1998
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SafePath Laboratories, LLC
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Partner & Vice President
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Sister company to LMD Laboratories, Inc.; oversight of Production of product line and Regulatory Affairs.
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1990 to 1996
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LMD Laboratories, Inc.
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Partner & Vice President
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Development & Manufacture of enzyme-immunoassay (EIA) product line for diagnosis of enteric pathogens. Expert supervised laboratory and manufacturing scale up of product line and facility from R&D through Production establishing Standard Operating Procedures, Documentation and Quality programs per GLP/cGMPs. Directed in-house and contract manufacturing including private label of OEM product line. Development, Implementation and Oversight of Operations, Training, Safety & Regulatory Affairs. Established company protocols: e.g. Equipment Calibration / Process Validation / Facility BioSecurity. Expert managed complete oversight of development and implementation of manufacturing capabilities and Regulatory Affairs.
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1985 to 1990
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BME International
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Owner - Independent Contractor
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Expert contracted for technical services to start up bioscience companies (primarily LMD Laboratories, Inc.) for product R&D and manufacturing process development (including all paperwork, validation, safety, training, you name it he did it). During this time, Expert also maintained commercial culture of several pathogenic strains of protozoa as source of antigen and antibody for industry and research institutions.
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1982 to 1985
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Biomedical Endeavors
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Owner - Independent Contractor
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Expert provided logistic and technical support services for biological field studies to research organizations for scientific expeditions, also ship borne hydrographic expeditions offshore and deep ocean Pacific. Expert coordinated transport of personnel and equipment, established and maintained base of operations and support for scientists and crew. Also, shipboard fire & damage control and field medical services.
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Associations/Societies
Over the past 25 years, professional affiliations have been considerable and include both scientific and industry service organizations as well as numerous personal and professional development courses attended.
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Professional Appointments
• Industrial Liaison Committee – American Society of Parasitologists. '94-'98, Chair '96-'98.
• Organizer/Moderator – ASP/Industrial Liaison Symposium. ASP Annual Meeting '97.
• Delegate – Medical Delegation to China and Mongolia – Citizens Ambassador Program, '95.
• Committee for Parasite Biodiversity – American Society of Parasitologists. '91-‘94, Chair, '94.
• Representative for Parasite Biodiversity – American Society of Parasitologists'89.
• Representative for Parasite Biodiversity – American Association of Veterinary Parasitologists '89.
• Parasite Study Group – Hospital, San Diego Zoological Society & the Department of Entomology, San Diego Natural History Museum '85-'89.
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Awards/Recognition
Appreciation for Dedicated Service -
Steering Committee Chairperson -
Community Emergency Response Team CERT -
Coronado, CA
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Publications and Patents Summary
Expert has previously published three volumes of a professional newsletter and has had several photographs published. Expert continues to publish newsletters and maintains a variety of websites for organizations presently involved with.
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| Government Experience: |
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Agency |
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Role |
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Description |
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1998 to 2000
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Major Metropolitan Area
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Advisor
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Expert provided advice regarding development of Consequence Management Program for Biological Terrorism.
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1997 to 1999
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City Government
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Board Member
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Emergency Preparedness Board.
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1978 to 1979
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City Council
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Member
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Expert, appointed by Mayor, sat as interim city council member.
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1997 to 1999
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City Government - Fire
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Steering Committee Chair
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Community Emergency Response Team (CERT)
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| Selected Consulting Examples: |
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Expert developed methodology for testing for pathogen reduction in medical device for the collection of specimen (urine) in a hospital setting. Expert provided analysis of data to be submitted to regulatory agency for product clearance and product literature. Expert also provided training to sales personnel regarding application of product.
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Expert arranged for and provided analysis for product testing according to regulatory standards. Expert provided interface with testing laboratory to facilitate third party 'arms length' testing and to interact with regulatory agency on behalf of the company.
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Expert provided research on materials and technologies used by client' competitors and provided competitive intelligence to client on competitors products and activities.
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Expert represented client in several distributor / customer relation situations to benefit of client and satisfaction of distributor / customers. Expert provided technical support to client during negotiations with client' client to handle and put into perspective questions and concerns of client' client resulting in a positive completion of contract.
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Expert was able to connect client with expertise outside of his own focus and, working in concert, address client' concerns and resolve issue.
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Recent Client Requests:
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Diagnostic testing expert for consulting on development of a medical diagnostic test.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Expert Witness Experience Summary:
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Expert provides for background information research, analysis and technical services (e.g. laboratory testing) for primary expert witness.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Country / Region |
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Summary |
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1995 to 1995
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China / Mongolia
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Medical Delegation – Parasitology - Citizens Ambassador Program.
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1994 to 1994
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Turkey
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International Congress of Parasitology.
Expert attended as delegate representing US company.
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1982 to 1985
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Mexico
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Expert provided logistic and technical support services for biological field studies to research organization for scientific expeditions. Expert coordinated transport of personnel and equipment, established and maintained base of operations and support for scientists and crew.
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| Language Skills: |
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Description |
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Spanish
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Expert is not fluent but has traveled and worked in Mexico with little language difficulty.
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Russian
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Expert is not fluent but has provided translation of scientific journals.
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Expert has a broad knowledge of the sciences especially the biosciences. Expert has maintained a broad and diverse review of the biosciences industries for about twenty-five years. Expert has been called "visionary" in regards to industry direction and growth.
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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Training/Seminars
Expert has provided training in the areas of technical expertise and safety for his own employees. Expert has also provided training to client' employees for technical capabilities in operations validation, manufacturing processes, inventory and quality control as well as to sales personnel regarding product.
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Supplier and Vendor Location and Selection Expert has sourced materials and suppliers for his own company's products and for clients products to meet required specifications. Expert has qualified vendors for production capabilities, quality control and ensure that vendors can meet regulatory guidelines and pass regulatory inspections.
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Other Skills and Services
Beside being known for his organizational skills, Expert is also methodical in his approach to problems with good deductive and mechanical skills. Expert especially enjoys using the visual arts of photography and videography to explore the natural sciences.
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Education
