EXPERTISE

· Polymer synthesis and characterization for medical device and controlled release applications
· Process development in fields of injectable microcapsules, polymer extrusion, intravenous catheters, cosmetics, pharmaceutical softgels, and paintballs manufacturing
· Research project management from concept, strategic planning, formulation and process development, through implementation of stabile manufacturing process

 
· Statistical Process Control and Design-of-Experiments methods for process analysis and quality improvement of softgel manufacturing operations
· Quality assurance administration including development and implementation of Standard Operating Procedures, test methods, and process documentation
· Chemical and physical properties testing
· Formulation of paintball fills, shells, and colors
· Formulation of cosmetics, pharmaceuticals, and industrial chemicals
· Knowledgeable in Good Manufacturing Practices (GMP) procedures for medical devices and pharmaceuticals

PROFESSIONAL EXPERIENCE

Currently Consultant to paintball manufacturers and pharmaceutical softgel manufacturers

Technical Services Scientist, R P Scherer NA:

Technical Services Department:
· Developed gelatin solution manufacturing processes for use in pharmaceutical softgel capsules. Worked with team to validate processes for use in a FDA approved facility.
· Used statistical analysis to develop and implement process controls to improve pharmaceutical capsule quality and reduce product defects.
· Worked with experienced Technical Services team to solve problems in all areas of softgel manufacturing, including training operators on new procedures or process changes.
Paintball Facility:
· Acted as sole technical person for the facility dedicated to paintball production. Developed and implemented paintball product compositions from concept to stabile manufacturing. Responsible for all formulations, process improvements, product quality issue resolution, in-process procedures and documentation, and new technology research and development.
· Established and administered Quality Control systems for raw materials used in the manufacture of paintballs and cosmetic capsules. Established raw material specifications, test methods and documentation. Established finished product standards and test methods.
· Accomplished process quality analysis and implemented improvements resulting in significant paintball product quality improvements. Scherer paintball products continue to lead the market.
· United States Patent granted for paintball fill composition.
· Interfaced with customers to resolve product quality issues and to establish requirements for new products.
· Participated in ASTM meetings and contributed proposals to establish paintball standards.

Technical Director, Vin-Dotco, Incorporated

· Responsible for formulation of industrial cleaners, solvent solutions, and personal care products using environmentally safe ingredients. Implemented new products into manufacturing and supplied all needed technical support. Established process documentation systems and process quality standards.
· Established and administered quality assurance systems for manufacturing environmentally safe industrial and consumer products in compliance with FDA, CPSC, and EPA requirements.
· Granted six United States Patents for environmentally safe industrial cleaners and personal care products.

Senior Scientist, R&D, CRITIKON, Incorporated (a Johnson & Johnson Company)

· Managed Characterization Group responsible for material characterization in support of medical device research and development. Participated in synthesis of polymers, extrusion processes development, and pilot production of new polyurethane intravenous catheters. Supervised technical personnel.
· Directed and carried out research on thromboresistant catheter coatings including in-vivo testing.
· Supported R&D and manufacturing of cardiac catheters, blood pressure monitoring systems, and intravenous fluid pumps with polymer material and processing issues.

Assistant Chemist, Southern Research Institute

· Synthesis, processing, and characterization of biomedical polymers including silicones, acrylic hydrogels, biodegradable polyesters, and polyurethanes. Applications included controlled release drug delivery devices, maxillofacial prostheses, contraceptive l.U.D., and injectable microcapsules.

PROFESSIONAL MEMBERSHIPS AND PATENTS

· Inventor of seven United States and International patents
· Member of The American Chemical Society


EDUCATION

· Bachelor of Science, Chemistry; Biology Minor, University of Alabama in Birmingham, 1981

  Continuing Education courses:
> Polymer Chemistry, ACS short course, Blacksburg, Virginia
> Supervisory Development, Johnson & Johnson
> Quality Education System, Crosby Quality Institute
> Water Soluble Polymers, ACS short course, Boston, MA
> Polyurethane Technology seminar, Clemson University
> Crystallization and Mechanical Behavior of Polymers, Society of Plastics Engineers course
> Surface Characterization of Materials for Biomedical Applications, Society of Biomaterials Symposium
> Medical Plastics Technology, Society of Manufacturing Engineers course
> Advanced Statistics, Johnson & Johnson
> Statistical Process Control, Johnson & Johnson
> Beyond SPC, Design of Experiments, Besterfield and Associates course
> Certified Quality Technician Course, American Society for Quality Control (ASQC)




Bayless Technologies, Inc.
4113 N. Forbes Rd. Plant City, FL 33565
Phone / FAX: (813)707-1770

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