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Resume of VHN, Ph.D.
Consultant
EXPERTISE AND SERVICES
Chemical Engineer, Research and Development Consultant, Pharmaceutical and Nutraceutical Product Development Specialist, Technology and Manufacturing Consultant, Engineering Failure Analysis, Accident Investigation, Accident Reconstruction, Specialist, Forensic Analysis, Investigation, Product Liability, Expert Witness Testimony, Patent Infringement, Expert Witness Testimony, Engineering Consulting ServicesExpertise in product and process development, GMP upgrades, new product introduction, active ingredients sourcing, API process development and requirements, manufacturing technology, technology transfer, validation, and due diligence of technology.
This associate has demonstrated specific expertise relative to pharmaceuticals, nutrition products, specialty chemicals, core competencies strategic alignment, cost saving opportunities, emerging technologies, and manufacturing technical support.
Additional experience and specialization includes plant design, plant construction and maintenance, plant safety and environment, process scale-up, 3rd party scale-up and manufacturing strategies, contract negotiation, outside technologies acquisition, new product field testing and marketing.
Other areas of specialty include solid dosage manufacturing forms, tablets, capsules, softgels granulation, fluid bed and spray dryer processing, encapsulation, milling and dry blends, tablet compression and coatings, injectables and cream manufacturing, ointments, and emulsions.
Extensive knowledge regarding manufacturing strategies, lab process transfer, contract product development, finished dosage products, new equipment design, convex drying technology, belt dehydration process, rapid costing preparation, global physical product development (GPPD).
Other areas of interest include high shear granulation, ingredients slurrying and spray-drying, external sourcing, hardshell filling technology, powder characterization equipment, microencapsulation, low shear granulation, high shear granulation, blending, spray drying, juicing, supercritical fluid extraction and lyophilization. Knowledgeable in areas including document control, analytical methods, herbal extraction process, high-pressure synthesis labs, engineering labs, juicing and alcohol extraction processes, regulatory reviews, stability data, overage requirements, safety and efficacy data, label claim, and quality control.
Expertise includes microbial analysis, wastewater treatment, master validation plans and protocols, toxicological studies, statistical experimental designs, global strategies for farming, tablet and capsule products, packaging, active ingredient levels, USP-grade water, field testing and marketing, and vertical integration of the supply chains
PRINCIPAL INDUSTRIES SERVED
Chemical, Construction, Environmental, Manufacturing, Nutritional Products, Occupational Safety, Packaging, Pharmaceutical, Wastewater Treatment
EDUCATION
Ph.D., M.Sc., Chemical Engineering, University of Notre Dame
B.Sc., Chemical Engineering, Panjab University, Chandigarh, India
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing chemical engineering consulting, research and development, technology and manufacturing consulting, failure analysis, forensic engineering, and related expertise to a wide variety of clients.
Speak to this experienced, world-class expert now.
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Executive Level Product Development Consultant
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Duties included assessment of free-standing product development centers of an international corporation in Canada, Mexico, Puerto Rico, Switzerland, Poland, and Hungary. Evaluated the mission (both regional and global), the resources, the personnel, and the ongoing work at each center. Recommendation was to fold the key centers into a corporate function of global physical product development (GPPD), which was accepted. Invited to head the new function as its interim vice president for the remainder of contract. Was also a member of the executive team of Global Manufacturing & Supply (GMS). The initiatives carried out involved close interaction and cooperation with vice presidents. Key accomplishments included development and launch of numerous products, GMP upgrades, new product introduction (NPI) at the corporate and regional levels, integrating marketing, corporate R&D, GPPD and manufacturing, sourcing active ingredients for new products in the pipeline, with sufficient flexibility to phase in existing API requirements, staffing recasting to match redefined missions, establishment of contract product development initiatives for Personal Care products, development of 3rd party scale-up and manufacturing strategy, development of the API processes for several finished dosage products, development and adminstration of annual expense budget of $5,000,000, management of R&D groups at three locations-Mexico City, Puerto Rico and Rzeszow, Poland.
Pharmaceutical and Nutraceutical Industry Consultant
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Provided support to the pharmaceutical and nutraceutical industries in the areas of strategic alignment of core competencies, cost saving opportunities and emerging technology impacts.
Shaklee Corporation, Hayward, CA
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Led a project on the consolidation of core competencies. Evaluated the mission and equipment of three QC laboratories: analytical methods development, analytical services including stability, and microbial analysis. Recommendations to outsource some of these activities, relocate some others to the manufacturing plant, and to relocate the rest to its headquarters building, were accepted. Prepared the design of the new labs. Carried out a full-time consulting assignment, leading a high level cross-functional team and the consumer products division of Yamanouchi Pharmaceutical Company, on a project to consolidate its core competencies.
Director of Research & Development/Nutrilite Division, Amway Corporation, Buena Park, CA
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Nutrilite is the $1 billion dietary supplements division of Amway. Responsible for product and process development, and for providing technical support to manufacturing and global agro operations. Developed new ecinacea products (tablet and liquid delivery) by developing new juicing and extraction processes and designing new equipment and new formulations. This helped achieve vertical integration of the supply chain. Shifting from external sourcing of the active to Nutrilite-grown herbs led to the launch of a more potent, and yet cheaper, product line. Changed the entire upstream processing of an existing product line from high shear granulation of one of the ingredients to a newly developed co-process which involved combining all ingredients, slurrying and spray-drying them together (process led to steep decline in scrap and rework, saving $3,000,000 annually). Developed new 2-piece hardshell filling technology for both powders and liquids centered around the use of MG2 machines. Successfully launched six new products. Successful scrap material reduction project was achieved over a three year period by developing new robust processes (upgraded the quality of staff, shifted the focus of development to the pilot scale and used statistical experimental designs for bench-top work). Led the $4 million expansion of the pilot plants at Buena Park (equipment for powder characterization, tablet compression, coating, 2-piece hardshell, microencapsulation, and packaging), and Lakeview (equipment for dehydration-belt and rotary driers, low shear granulation-Glatt fluid bed, roller compaction and high shear granulation-Lodige with choppers, Schugi, blending, spray drying, juicing, supercritical fluid extraction and freeze drying). Member of the management teams responsible for drawing up master validation plans (validation protocols for existing and new equipment and facilities, cleaning, manufacturing and packaging, document control, analytical methods & equipment).
As a member of the Management Regulatory Review Team, routinely assessed all pertinent data (stability protocol for the specific market, stability data, overage requirements, safety and efficacy data, and label claim) for each product in the R&D pipeline. Carried out due diligence of Ocean Nutrition Canada (ONC) from a technology and manufacturing perspective, resulting in Amway acquiring a majority share of ONC. Oversaw negotiation of contracts for 3rd party manufacture by Nutrilite. Prepared rapid costing and supported preparation of the business contract. Chaired a strategy team which developed and implemented global strategy for farming (of organic crops, fruits and herbs) and processing, spanning multiple sites in Brazil, Mexico, California and Washington. The other members were Director of Global Farming, CFO of Nutrilite, and Director of Lakeview Operations. Provided active leadership for the market launch of new and revised products. Led all product introduction teams (seven at the peak), from R&D through market introduction at Sandoz. Developed and administered annual expense budget of $5,000,000. Managed four groups in three locations; two finished delivery form groups at Buena Park, CA, the concentrates group at Lakeview, CA, and the nutrition group at Ada, MI.
Achieved recurrent savings of $3 million/year at by implementing process improvements in the manufacture of Acerola and Herbal concentrates. Implemented these improvements at a contract manufacturer (Botucatu, Brazil) and two Nutrilite plants (Lakeview, CA and Fortaleza, Brazil). Led the development of a new process for acerola concentrate. Oversaw the preparation of the process design of a new plant, and helped commission this plant near Fortaleza in the State of Ceara, Brazil. Developed and implemented a new herbal extraction process at two contract manufacturing plants (New Jersey and Sao Paulo, Brazil) and a Nutrilite plant in Lakeview, CA. This resulted in predictable and consistent levels of active ingredient levels in tablet and capsule products.
Director of Technology and Manufacturing, Brantford Chemicals/Apotex, Brantford, Canada
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Identified a need and designed a Technology Center at Brantford Chemicals as a part of the 10-phase master plan for BCI. It included research labs for scientists, analytical labs for control and methods development, a high-pressure synthesis lab, an engineering lab, a safety lab, a pilot plant, a wastewater treatment plant and office space for scientists and engineers.
Director of Engineering, Boehringer Ingelheim Chemicals, Petersburg, VA
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Was responsible for plant design (process & project engineering), construction, safety & environment and maintenance. Member of the management teams responsible for drawing up master validation plans (validation protocols for existing and new equipment and facilities, cleaning, manufacturing and packaging, document control, analytical methods & equipment). Transferred the lab process for the drug Nevirapine from Boehringer Ingelheim’s German base to Virginia (scaled up the critical steps, built a new manufacturing plant and started up production). Led the design and construction of a grass roots facility meeting full GMP requirements for the manufacture of the drug Nevirapine. The $10 million project was spread over several A&E firms, contractors and sub-contractors. Developed new systems and procedures for carrying out IQ, OQ & PQ of the facility, and the subsequent validation of production therein. Designed and built a new purified water facility to provide USP-grade water for manufacture of API's and also WFI-grade water.
Director of Process Technology, Sandoz Chemicals Corporation, Charlotte, NC
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Directed scale-up of laboratory processes to manufacturing, provided technical assistance to three plants and oversaw acquisition of outside technologies.
Research Section Manager/R & D Division, Rohm and Haas Company, Bristol, PA
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Was responsible for process development, support for toxicological studies, field testing and marketing during product development, and for providing technical assistance to plants. Developed new convex drying technology for the DITHANE fungicide, implemented in plants at Lauterbourg (France), Barranquila (Columbia), Sao Paulo (Brazil), and Thane (India).
ADDITIONAL EXPERIENCE
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Partnered with researchers at Michigan State University for the development of a natural pain reliever, called herbal aspirin. Organized effort at UCI’s Susan Samueli Center for Competitive and Alternative Medicines for starting a human nutrition research center.
Developed the process for, designed and started up a plant near Fortaleza in the State of Serra, Brazil for Nutrilite/Amway
Transferred the process know-how from Ingelheim, Germany, to Petersburg, Virginia for building the API plant for Nevirapine
Licensed continuous powder drying technology from Buss in Switzerland, later implemented for Rohm and Haas plants in Lauterbourg (France), Barranquila (Columbia), Sao Paulo (Brazil), and Thane (India)
PUBLICATIONS
Awarded US patents for a new juicing process, an alcohol extraction, and a belt dehydration process.
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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| Chemical Engineer, Research and Development Consultant, Pharmaceutical and Nutraceutical Product Development Specialist, Technology and Manufacturing Consultant, Engineering Failure Analysis, Accident Investigation, Accident Reconstruction, Specialist, Forensic Analysis, Investigation, Product Liability, Expert Witness Testimony, Patent Infringement, Expert Witness Testimony, Engineering Consulting Services | |
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| Resume of JAT | leadership and management specialist, product design and development consultant, technology development, systems engineering, manufacturing engineering consultant, specialist, forensic analysis, investigation, product liability, expert witness testimony, patent infringement, expert consulting services |
| Resume of CHL | chemist, biotechnology consultant, product and process validation consultant, quality assurance consultant, accident investigation, accident reconstruction, specialist, forensic analysis, investigation, product liability, expert witness testimony, consulting services |
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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