pharmaceutical, medical device validation expert consultant resume
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Resume of VHN, Ph.D. Consultant
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  • Chemical
  • Construction
  • Environmental
  • Manufacturing
  • Nutritional Products
  • Occupational Safety
  • Packaging
  • Pharmaceutical
  • Wastewater Treatment

This expert received a Ph.D. and an M.Sc. in Chemical Engineering from the University of Notre Dame.

This expert received a B.Sc. in Chemical Engineering from the Panjab University in Chandigarh, India.

Pharmaceutical, Nutraceutical Manufacturing Expert Consultant Resume

This expert is experienced in product and process development, GMP upgrades, new product introduction, and active ingredients sourcing. API process development and requirements, manufacturing technology, and technology transfer are other areas of expertise this consultant has. This expert also has experience in validation, and due diligence of technology.

This associate has demonstrated specific expertise relative to pharmaceuticals, nutrition products, and specialty chemicals. This expert also has experience in core competencies strategic alignment, cost saving opportunities, emerging technologies, and manufacturing technical support.

Additional experience and specialization of this consultant includes plant design, plant construction and maintenance, plant safety and environment. This expert also has knowledge in process scale-up, 3rd party scale-up and manufacturing strategies, contract negotiation, and outside technologies acquisition. This consultant also has experience in new product field testing and marketing.

Other areas of specialty of this expert include solid dosage manufacturing forms, tablets, capsules, and softgels granulation. Fluid bed and spray dryer processing, encapsulation, milling and dry blends are other areas of expertise this consultant has. This expert also has knowledge in tablet compression and coatings, injectables and cream manufacturing, ointments, and emulsions.

This consultant has extensive knowledge regarding manufacturing strategies, lab process transfer, contract product development, and finished dosage products. Further expertise of this consultant includes new equipment design, convex drying technology, and belt dehydration process. This expert also has experience in rapid costing preparation, and global physical product development (GPPD).

Other areas of interest of this expert include high shear granulation, ingredients slurrying and spray-drying, external sourcing, and hard-shell filling technology. This expert also has interest in powder characterization equipment, microencapsulation, low shear granulation, and high shear granulation. Blending, spray drying, juicing, and supercritical fluid extraction and lyophilization are other areas of expertise this consultant has. This expert is knowledgeable in areas including document control, analytical methods, herbal extraction process, high-pressure synthesis labs, and engineering labs. Juicing and alcohol extraction processes, regulatory reviews, stability data, and overage requirements are also areas of expertise this consultant has. This expert also has experience in safety and efficacy data, label claim, and quality control.

Expertise of this consultant includes microbial analysis, wastewater treatment, master validation plans and protocols, and toxicological studies. Statistical experimental designs, global strategies for farming, tablet and capsule products, and packaging are other areas of expertise this consultant has. This expert also has extensive knowledge regarding active ingredient levels, USP-grade water, field testing and marketing, and vertical integration of the supply chains.

Consultant, Kevin Kennedy Associates Inc.

Providing chemical engineering consulting, research and development, technology and manufacturing consulting, failure analysis, forensic engineering, and related expertise to a wide variety of clients.

 

Executive Level Product Development Consultant

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

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

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

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

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

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

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

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).

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