Expert Details

Expert in Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC

Expert ID: 723350 California, USA

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With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of these involved acrylic resins especially as it relates to PSAs (pressure sensitive adhesives. In addition, Expert holds 3 patents in the area of adhesives.

Expert has spent over 35 years developing adhesives, resins and advanced composites for a variety of applications. Expert started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. During this time at companies like Lockheed Martin much emphasis was placed on failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis.

Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. During this time at companies like Lockheed Martin much emphasis was placed on failure analysis. In the process expert further refined his expertise in the area of adhesion science and surface analysis. Much effort was also placed on the aging of adhesives and therefore adhesion loss as companies like Lockheed Martin and Boeing try and increase to life of their inventory.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. Formulation development was an essential part of his job function for many years and expert had to learn how to formulate for maximum adhesion through the use of adhesion promoters, etc.

Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. Formulation development was an essential part of expert's job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis.

As with developing adhesives, he gained expertise in the areas of testing adhesives. This included the typical mechanical test methods of tension, flexure, peel, compression to more complicated method like toughness. Some aerospace applications were also concerned with out gassing and so he also added that to his testing expertise. These tests were dynamic and at times included fatigue testing under very different environments from ambient to hot wet conditions and salt spray, etc.

To successfully develop adhesives, you need to know something about adhesion theory. Much of adhesion theory has to do with surface chemistry and topography of the surface. It was always a goal to increase the adhesive strength. Knowing the theory of adhesion and seeing SEM photos was an essential element in that process.

Much of his time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. These were typically thermoset adhesives that required curing such as epoxies, bismaleimides, polyimides, etc. Developing the cure cycle was an essential part of the adhesive development. Formulation development was an essential part of expert's job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis. Expert also developed adhesives for other applications that included commercial as well as some medical device medical applications. Knowing the application is essential to developing the right adhesive.

Formulation development was an essential part of expert's job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis. He also developed adhesives for other applications that included commercial as well as some medical device medical applications. Knowing the application is essential to developing the right adhesive. During expert's work history he served in a variety of process development roles as they relate to adhesives. This included the fabrication of medical devices at Affymetrix. In this application he had to "customize" equipment to dispense an acrylic adhesive in a precise geometry and of a precise weight around an optical window. Other applications of adhesive dispensing were in Aerospace applications where, like with medical devices, location and quantity of adhesive were critical.

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. In addition, expert holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives were focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. Formulation development was an essential part of his job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on post mortems failure analysis. In the process he further refined his expertise in the area of adhesion science and surface analysis. Expert also had to formulate for the job requirements such as hot wet environments or electrical properties (either a conductor or insulator).

Expert has spent over 15 years developing adhesives, resins and advanced composites for a variety of applications. Expert started at the bench chemist level and worked his way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Over these years he worked closely with manufacturing and in some positions was responsible for manufacturing of the adhesives (thermset).

As with developing adhesives, he gained expertise in the areas of testing adhesives. This included the typical mechanical test methods of tension, flexure, peel, compression to more complicated methods like toughness. Some aerospace applications were also concerned with out gassing and so he also added that to his testing expertise. These tests were dynamic and at times included fatigue testing under very different environments from ambient to hot wet conditions and salt spray, etc. He also supplied adhesives into applications where their electrical properties (either conductor or insulator) were of critical importance. As a result, he also got involved in testing for these properties as well as optical properties like fluorescence.

Expert has spent over 35 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing advanced composites was focused on the highly demanding Aerospace requirements that varied from commercial aviation to space vehicles, satellites, and missiles at all of the major aerospace companies.

Expert has spent over 35 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing advanced composites was focused on the highly demanding Aerospace requirements that varied from commercial aviation to space vehicles, satellites, and missiles at all of the major aerospace companies. Expert was on both sides of advanced composites: the developer and the user. As a result he has a great deal of knowledge on all aspects of the technology. This includes failure modes and mechanical testing.

As a PhD chemist, he supplied advanced materials such as adhesives and composites into all of the major aerospace companies. He also worked for Boeing and Lockheed Martin where he had groups responsible for the use of advanced materials that included metals and non-metals. These non-metals were often specialized coatings for a variety of different applications including heat, radar absorbing, etc.

Expert started working in the labs. He was trained to analyze data and my skills eventually lead me into technical QA roles. His first involvement was providing leadership to a company supplying materials into the circuit board industry. Then at Lockheed Martin he served in a variety of Materials/QA roles where he had the responsibility to look at data and draw conclusions. This lead to a complete transition in technical QA roles within the medical device and pharma industries. In all of those applications he used his technical skills at reviewing data to make informed QA decisions.

With autoclave two areas of his career come to the surface. The first has to do with curing of advanced composites and adhesive. These thermosets were often cured in an autoclave. The second has to do with his experience in the medical device/pharma/bio pharma part of my career. Here autoclaves were standard for sterilization of equipment and materials typically used in packaging of the products. He is very familiar with both very different applications.

Expert has spent over 35 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. In addition, he holds 3 patents in the area of adhesives and advanced composites. Much of the time developing adhesives was focused on the highly demanding Aerospace quality adhesive. This meant developing formulations with good adhesion. These were typically thermoset adhesives that required curing such as epoxies, bismaleimides, polyimides, etc. Developing the cure cycle was an essential part of the adhesive development. Formulation development was an essential part of my job function for many years and he had to learn how to formulate for maximum adhesion through the use of adhesion. During this time at companies like Lockheed Martin much emphasis was placed on failure analysis. In the process he further refined my expertise in the area of adhesion science and surface analysis. He also developed adhsives for other applications that included commercial as well as some medical device medical applications. Knowing the application is essential to developing the right adhesive.

Expert has worked in the medical device industry with such materials as collegan which was derived from a bovine and a human source. The human source involved the culture of human cells on a mesh. The processing of the collegan from the cells would be considered bioprocess engineering. He was responsible for developing new processes and improved processes. All of this was done in clean room environments as low as class 100. This was considered an aseptic process.

His experience with advanced composites covers continuous fiber and short fiber composites. He worked extensively with carbon fiber composites primarily for aerospace applications. Other fiber include glass, Kevlar, Boron. In developing composite materials for the aerospace industry it was part of Expert's job to test these materials to ensure that they meet the demanding requirements. As a result, he became very familiar with the various mechanical test methods (tension, compression, flexure, toughness, etc.) as well as some more exotic testing as required. Working at Lockheed Martin he was also on the other side using these materials. There he continued to gain expertise with testing of the composites being fabricated.

For most of his career he worked in highly regulated environments. Much of time this meant the FDA regulations for pharmaceuticals. He is very familiar with 21 CFR 210 and 211 as well as the ICH guidance for API's (Q7A). Much of his career has been spent interpreting and following these regulations and guidance documents. Much of expert's time developing advanced epoxy composites was focused on the highly demanding Aerospace requirements that varied from commercial aviation to space vehicles, satellites, and missiles at all of the major aerospace companies.

Expert has spent over 35 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked my way up into R&D management. Most of these involved epoxy resins. He worked extensively formulating 2 part curing epoxy adhesives as well as one part adhesive films and composite materials.

Working on both sides of epoxy chemistry: the developer and the user, he needed to be very familiar with how these materials are used. This meant formulation for specific final properties such as high temperature performance or toughness or on the user end selecting the appropriate epoxy material that would meet the demanding specification requirements. Thermal properties were often on the top of the list for most applications and he developed and selected the appropriate epoxy resin for the thermal environment in which it would be used.

At times the viscoelastic properties of the epoxies were of critical importance to the end users. As a result, he had to take this into consideration when developing new materials. This resulted in becoming very familiar with the use of rheology for determining the viscoelastic properties of epoxy materials. Working a Lockheed martin as the user he also had to be aware of the viscoelastic materials from a cure and use perspective.

A large part of his career was spent in process development and QA working for medical device companies. These devices included mechanical, chemical synthesis, hardware, software, and biological materials. Expert has extensive experience with product development and QA of medical devices (21 CFR 820). As part of QA working for medical device companies it was expert's job to ensure that risk or hazard analysis was performed during the product development. This at times included FMEA as well as other techniques to assess that a safe and effective product was being developed.

Expert has served in QA positions where he was responsible for the final inspection of medical devices in the course of product development. This inspection was essentially a validation that the device is meeting the design out put from the detailed DHF. He served in QA at two very different medical device companies. In both companies he was a member of QA. He knew that when a product was released he was assuring the FDA and other regulatory authorities that the device was safe and effective. Working closely with RA he was aware of the liabilities as prescribed by the FDA should there be a problem with the device.

He has been involved in medical devices at two different companies. In both he served in QA role working very closely with QC during the manufacturing process. This meant determining AQLs for various parameters as well as investigating OOS or OOT conditions. Expert was intimately involved in all aspects of their testing.

Expert has been involved in medical devices at two different companies. In both he served in QA role working very closely with the various technical groups involved in the product development. As QA, Expert was responsible for the DHF and ensuring that the design output equals the design input. This also involved resolving problems that might arise during the development as well as conducting the risk analysis.

He has worked in QA in a small molecule & large molecule (biologics) Pharma companies. In this role he managed the final disposition of API lots. Lead and document problem investigations, deviations, and complaints. Managed and lead API validation for GMP/GLP operations, including equipment and facility qualification and supporting computer systems (21CFR part 11). Provided QA/technical oversight to API release, aseptic processing, validation, investigations, deviations, and complaints at contract manufacturing sites (CMO’s). Responsible for review of the CMC section of regulatory filings. Worked with Regulatory for IND/NDA’s, updates, and reportable process changes for worldwide compliance. Developed and enhanced validation systems and documentation standards/templates, train functional departments. Working closely with QC develops and validates new test methods and stability protocols. Key team member/lead in FDA/regulatory inspections (internal and CMO’s). Supervise professional staff. Assured GMP/GLP compliance at contract sites for API manufacturing. Managed and perform internal and external GMP/GLP audits. Planned and direct QA activities in support of API clinical and commercial manufacturing including GCP support. He has completed validation of new pilot manufacturing facility ahead of schedule. Worked closely with an API contractor to improve their quality system resulting in reduced OOS, and OOT conditions and deviations.

Expert is certified and an ASQ (American Society for Quality) quality auditor. As such he has conducted several hundred first and second party quality audits.

• Deposition, Court Testimony and Expert Reports for adhesive & fiber composite root cause failure analysis.
• With extensive experience in FDA Quality System Regulations (QSR, 21 CFR Part 820) can provide expertise on failures to comply with FDA regulations as they relate to materials science including, but not limited to: Design Control, Production & Process Control, Preventive Maintenance (PM), Design & Process Validation, Management Responsibility, Purchasing Controls, Incoming Inspection, Corrective & Preventive Actions (CAPA), Acceptance Criteria, Storage & Distribution and Compliant Handling.
• Provided expertise in the selection, processing and use of adhesives in difficult to bond and challenging environemnts including under FDA (medical Devices) and other regulatory agency regulations.
• Consulted with the pharmaceutical, biotech and medical device communities for quality improvement, process engineering, development, manufacturing and contracted services.
• Consulting in the commercial and military aerospace industries and holding a secret clearance (currently inactive).
• Design and analysis of electrically conductive filled adhesives for use in microelectronics. Often the use has been in a medical device.
• Designed complete quality systems for FDA, ICH and ISO compliance.
• Performed Quality Audits of contract service providers for compliance to governing regulations (FDA, EU, etc.)



Expert has experience with process development. He has performed stability testing and can help with developing the appropriate documentation for the process. Expert can provide manufacturing support for existing and developing processes. He also can assist with adhesives design and testing. Expert has been involved in numerous consulting jobs that have involved developing and/or selecting the proper adhesive to meet very demanding applications in the areas of medical devices, aerospace, and other commercial applications.

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1979 Degree: Ph.D Subject: Organic Chemistry Institution: University of Washington
Year: 1974 Degree: AB Subject: Chemistry, Chemical Engr. Institution: Cornell University
Year: 2005 Degree: Certification Subject: Regulatory Affairs Institution: San Diego State University
Year: 2003 Degree: Certified Quality Auditor Subject: Quality Assurance Institution: American Society for Quality

Work History

Years Employer Title Department Responsibilities
Years: 2005 to Present Employer: Undisclosed Title: Sr. manager Department: QA, Chemical manufacturing Responsibilities: Manage final disposition of API Assure GMP compliance at contract sites for API manufacturing. Manage and perform internal and external GMP audits. Plan and direct QA activities in support of API clinical and commercial manufacturing. Mlots. lots. Lead and document problem investigations, deviations and complaints. Manage and lead API validation for GMP operations at GFC, including equipment and facility qualification and supporting computer systems. Develop and enhance validation systems and documentation standards/templates, train functional departments. Provide QA oversight to validation at contract sites. Key team member/lead in FDA/regulatory inspections (internal and external). Supervise professional staff.
Years: 1999 to 2005 Employer: Affymetrix Title: manager Department: Manufacturing Development, QA Responsibilities: Quality: Represented Quality on new and sustaining project teams to assure QSR/cGMP/ISO compliance for medical devices and assisted in the development and implementation of validation test protocols, test methods, specifications, etc. In a QSR/ISO environment set the strategic direction for managing critical materials suppliers including new supplier qualifications and the recertification of existing suppliers. Lead supplier audit teams, the Supplier Review Board, and managed corrective and preventative actions (CAPA). Working closely with development, manufacturing, and suppliers, established criteria for qualification of new materials and processes which in many instances were treated as API’s.
Process: Lead project teams for support of new product/process development and improvements for existing manufacturing processes. Moved products from R&D small-scale non-optimal processes to the final production scale equipment and processes. Characterized various parts of the manufacturing process to develop and validate robust processes for consistent high yields. Developed materials specifications focused on the critical needs of the manufacturing process.
Years: 1989 to 1999 Employer: Lockheed Martin Title: Manager Department: R&D, Missiles & Space Responsibilities: Manager of Chemicals Support Group & Materials & Processes Program Manager. Materials & Processes Program Manager for a major developmental program. Responsible for supply base management including Quality/Process audits and process validation. Technical management for materials development, process development & validation support (polymers, films, adhesives, coatings, paints, potting compounds, gels, plastics, & hazardous materials and chemicals), chemical and physical characterization, materials selection and problem resolution, and vendor and subcontractor interactions. Promoted from Staff R&D Scientist conducting research in polymer formulation, adhesion and surface chemistry, adhesives, coatings/films for specialized applications, fibers, and resins. Developed/synthesized materials and processing techniques (coating, extrusion, injection molding, compression molding, RTM, thin films, etc.) and transition programs into production.
Years: 1988 to 1989 Employer: Advanced Dielectrics, Inc Title: Director Department: QA/QC Responsibilities: Technical Director directing the activities of Quality Assurance/Quality Control, Process Engineering, Analytical Chemistry, and R&D (web coating). Supported manufacturing and external customers for CAPA (Corrective and Preventative Actions) and complaint handling. Responsible for the research & process development of film adhesives and composite laminates for electronic circuit boards.
Years: 1988 to 1982 Employer: Dexter Corporation Title: manager Department: Hysol Division Responsibilities: Group Manager of Advanced Composites R & D Group. Conducted formulation and process development of thermoset and pressure sensitive adhesives and matrix resins and thermoplastic extrusion & injection molding. Synthesized new specialized adhesives and curing agents, conducted research in surface chemistry and adhesion science. Investigated new coupling agents, adhesion promoters and techniques (i.e. CVD, plasma). Performed chemical characterization and analytical process development. Promoted from Senior Chemist in the Polymer Technology Group to Project Leader and then to Group Manager.
Years: 1980 to 1982 Employer: Boeing Title: Sr. Materials Engineer Department: Materials Responsibilities: Senior Materials Engineer working on high performance adhesives, matrix resins and high strength fibers for advanced composites. Developed materials and process specifications. Provided program support and support for automated processing of composites.
Years: 1979 to 1980 Employer: Bio-Rad Laboratories Title: Chemist Department: Polymers Division Responsibilities: Research Chemist developing amphoteric oligomers and conducting polymer synthesis/modification for the bio-medical market.

Government Experience

Years Agency Role Description
Years: 1988 to 1999 Agency: Army, NASA Role: contractor Description: Materials & Processes Program Manager for a major developmental program. Technical lead for contractor interactions and responsible for supply base management including Quality/Process audits and process validation. Technical management for materials development, process development & validation support (polymers, films, adhesives, coatings, paints, potting compounds, gels, plastics, & hazardous materials and chemicals), chemical and physical characterization, materials selection and problem resolution, and vendor/contractor interactions. Promoted from Staff R&D Scientist conducting research in polymer formulation, adhesion and surface chemistry, adhesives, coatings/films for specialized applications, fibers, and resins. Developed/synthesized materials and processing techniques (coating, extrusion, injection molding, compression molding, RTM, thin films, etc.) and transition programs into production.

Career Accomplishments

Associations / Societies
American Society for Quality;
American Chemical Society;
The Society for the Advancement of Materials and Process Engineering;
The Society of Plastics Engineers. Board member of Advanced Polymer Composites Division
Licenses / Certifications
Certified ASQ Quality Auditor.
Regulatory Affairs Certification from San Diego State University.
Publications and Patents Summary
Expert has many publications and patents within his areas of expertise.

Additional Experience

Expert Witness Experience
Expert wittness expereince in the areas of adhesives and fiber reinforced laminates. This includes formulation of adhesive resins (epoxy, bismaleimide, polyimide, etc.) and laminate/prepreg formulations.
Training / Seminars
Systems Engineering/Project Management, Facilitating Creative Thinking, and misc. technical management, business accounting, and personnel development. Technical: Supply Base Management and Design of Experiment (DOE). Quality: Complying with cGMP and GMP Requirements, Quality Auditor, Regulatory Compliance for Biologics, ISO (Undisclosed) & ISO (Undisclosed), Risk Management/FMEA, Improving Inspection Effectiveness
Vendor Selection
Expert has worked on vendor selection in most of his past job experiences. As an ASQ Certified Quality Auditor, Expert has conducted over 300 audits to FDA regulations, ICH Guidlines, and ISO Standards.
Marketing Experience
Special skills in the formulation and use of adhesives and other resins for the medical device industry.
Other Relevant Experience
Expert has taught organic chemistry and biochemistry at the Community College and University level as well as classes on adhesion science and bonding, surface science, adhesive and resin formulation.

Fields of Expertise

acrylic resin, adhesion, adhesion loss, adhesion promoter, adhesion science, adhesion testing, adhesive failure analysis, adhesion theory, adhesive application, adhesive curing, aerospace adhesive, adhesive dispensing equipment, adhesive formulation, adhesive manufacturing, adhesive testing, advanced composite, advanced composite technology, aerospace coating material, aerospace engineering, analytical data quality assurance, autoclave, autoclave composite processing, bioprocess engineering, carbon composite, carbon fiber, composite material mechanical property, Current Good Manufacturing Practice, epoxy matrix composite, epoxy resin, epoxy resin thermal property, epoxy resin viscoelastic property, medical device design, medical device hazard analysis, medical device inspection, medical device safety, medical device manufacturing quality control, medical device product development, pharmaceutical quality assurance, quality auditing, expert witness, fiber-reinforced composite, human fatigue, Chemistry, Manufacturing and Controls, composite material characterization, quality assurance project plan, adhesive fracture, fiber wetting, qualification testing, epoxy chemistry, pharmaceutical manufacturer, medical device liability, bond strength, fabric coating process, analytical testing, epoxy curing, epoxy bonding, bioprocessing, epoxy structure, epoxy casting, medical device testing, epoxy-novolac resin, aerospace, epoxy resin physical property, adhesive formulation technology, adhesive material film, pharmaceutical industry, pharmaceutical engineering, quality assurance management system, quality improvement, quality assurance, adhesive material, quality, carbon, quality management, epoxy compound, epoxy adhesive, composite material, chemistry, biotechnology

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