Validation and cGMP Regulatory Compliance Expert Consultant Resume
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Resume of MKH
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  • Pharmaceuticals
  • Tissues
  • Medical Devices
  • Dietary Supplements
  • Excipients Manufacturing

This expert has a Ph. D. in Organic Chemistry from UCLA and a BS. in Chemistry from the University of California at Berkeley.

Validation and cGMP Regulatory Compliance Expert Consultant Resume

This associate is an expert in regulatory compliance, training, validation, and quality. Further expertise includes production and new product development management.

This associate is experienced in cGMP compliance in industries including pharmaceuticals, tissues and medical devices, dietary supplements, and excipients. Other areas of capability include experience in FDA regulated industries, audits, training and expert witness. Specific experience includes engineering and maintenance for vitamin E synthesis, spray drying plant, liquid food blends, and human nutrition premix.

This associate’s experience includes high tech pharmaceutical manufacturing, vitamin manufacturing plant management, and production supervision. This associate is a published author in areas related to validation, high performance quality, chemical engineering, and studies in stereochemistry.

Consultant, Kevin Kennedy Associates, Inc.

Providing expertise in chemistry, validation and compliance, cGMP regulatory compliance, quality, production, and engineering management, new product development, forensic investigation and analysis, expert testimony, and related expertise to a wide variety of clients.

 

Senior Partner, validation & compliance firm

Managed compliance, training, validation, and new product development projects. Wrote and executed validation protocols. Provided guidance to customers on cGMP compliance in a wide range of industries, including pharmaceuticals, tissues, medical devices, dietary supplements, and excipients. Developed many training classes and delivered them to a diverse audience in FDA regulated industries. Received recognition for excellent work and generated repeat business. Performed audits. Developed methods for helping organizations to convert training knowledge into behavior change in the workplace. Led multinational project teams. Insured that all members of the teams contributed despite the fact that they came from multiple countries and multiple companies. Expert witness. Authored articles.

 

Site Manager, pharmaceutical manufacturing site

Was in charge of Quality, Production, Engineering and Maintenance for Vitamin E synthesis, Spray Drying Plant, Liquid Food Blends, Human Nutrition Premix, shipping & receiving, hiring & firing; 120 people; $200M/yr in sales. Was responsible for tolling operations in multiple locations. Saved the business $5M in capital by tolling out new products rather than manufacturing in-house. Budget responsibility for $23M in fixed cost. Dotted line responsibility for other service groups. Converted business information management system to SAP. Constructed new technology distillation column, the first example of brand new technology to be built outside of corporate headquarters. Installed a new Distributed Control System, which allowed the identification of Key Process Parameters. Using SPC we established allowable ranges for the Key Process Parameters. By keeping the parameters within those ranges product quality was improved, end of pipe testing was reduced, downtime was minimized, and equipment reliability was improved. Overall savings were $1.8M/yr.

 

Plant Manager, Vitamins Plant, BASF

Managed production of Vitamin E, Spray Drying Plant, Liquid Food Blends, shipping & receiving, hiring & firing; 80 people. Upgraded cGMP compliance program to comply with new FDA regulations. Validated API processes in the plant. Used Design of Experiment techniques to reduce product overages and save $300k/y. Expanded Vitamin E Plant capacity by 30% while simultaneously reducing emissions. Used SPC to reduce variability in Spray Drying Plant and saved $200k/y.

 

Production Manager, Vitamins Plant, BASF

Managed production of Vitamin E, Spray Drying Plant, Liquid Food Blends, New Product Development, shipping & receiving; 45 people. Developed new method of purifying Vitamin E, which reduced waste and reduced costs by $100k/y. This new technology plus others that were developed in the Wyandotte Vitamins Plant were installed in other BASF vitamin plants around the world. Wrote Drug Master Files. Lead the justification process for new Liquid Food Blends Facility. Started up new Spray Drying facility.

 

Production Superintendent, Vitamin E Plant, BASF

Managed production of Vitamin E. Expanded capacity of plant by 100% with less than $1M total capital; 20 people. Was selected as ombudsman for production and maintenance employees who provided an incentive for them to decertify their union.

 

Startup Engineer, Polyol Plant, Washington, NJ, BASF

Helped to start up 5 kgal polyether polymerization reactors. Lead the startup of new prilling tower. Wrote SOP’s.

 

Pilot Plant Engineer, Wyandotte, MI, BASF

Managed production of herbicide production facility. Set monthly production records. Developed new purification process that stopped corrosion of glass-lined reactor.

 

R&D Chemist, Wyandotte, MI, BASF

Developed method for producing record high molecular weight polyether polyols.

Published author in areas related to validation, high performance quality, chemical engineering, studies in stereochemistry, and more.

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