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 Expert  728891

Expert in Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development

Available for your Consulting and Expert Witness Needs

California (CA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is well-versed in the FDA and rest of world drug and combination product regulations. His focus has been to develop the right product based on strong requirements to the patients to improve their lives.

As a pharmaceutical product developer, Expert has gained much experience in several areas. These include drug and excipient material science, specification setting, CRO and CMO management, active pharmaceutical product ingredient analytical sciences, drug delivery, formulation development and process development. As a six sigma black belt, Expert is always looking to improve the way business is performed, improving processes and eliminating waste.

In his product development role, Expert has written and reviewed CMC (chemical, materials and controls) sections of NDAs (new drug applications) for several drug delivery products, including oral, implantable, transdermal and electrolytic transdermal therapies. He has developed raw material portfolios for these type products, linking key materials to product requirements to insure their suitability for use. By setting relevant specifications and working with suppliers to maintain these specifications, Expert developed high reliability processes for the development projects.

He is also well versed in the regulations surrounding drug development, particularly on the materials, drug ingredients, drug products and quality areas. He recently took a class in "Interacting with the FDA". He keeps abreast of new requirements for the cGMP regulations, and is particularly adept at dealing with both the drug and medical device requirements for combination products.

Expert's original degree and work experience was in analytical chemistry, and he has expertise in analytical instrumentation and methodologies, particularly pertaining to drugs. He has a speciality in a subset of HPLC, ion chromatography. He has developed instrumentation and test methods for IC, while working for the market leader in the sector. He also has expertise in wet chemical analytical methods, polymer rheology and viscometry, physical test methods such as tensile testing and adhesive testing, and various forms of spectrophotometry.


analytical instrumentation




base (chemical)


bulk drug


controlled-release drug delivery




drug development


drug formulation


drug regulation


ion chromatography


pharmaceutical analytical chemistry


drug delivery


pharmaceutical drug


pharmaceutical product development

Expert holds a six sigma black belt in process development and improvement. He has led several projects that have eliminated waste and improved the way processes are performed. These projects included drug excipient manufacturing development, electronic component manufacturing, and financial process business improvement. He has also mentored several six sigma green belts and taught six sigma tool methodologies to team members.

As a six sigma practicioner, Expert is not dogmatic about tool usage as many other practicioners are. Rather, he espouses a softer approach, where the tools are used as indicators and aids to really understand the root cause of problems and come up with achievable solutions. He is a big proponent of setting metrics to assess and measure the health of processes, and to take a big picture view of what's actually happening in the processes.


six sigma quality

Show Secondary and Basic Areas of Expertise
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;  and Hayward, California.

Year   Degree   Subject   Institution  
1987   Ph.D.   Inorganic/Analytical Chemistry   Rice University  
1981   BSc   Chemistry   Hobart College  

Work History:
Years   Employer   Department   Title   Responsibilities

2010 to





Senior Scientist (contract)


Expert is working with the development teams to a develop skin adhesive for a electronic patch. He is also working with them on developing erodible films and improving the chemical performance of their batery technology, all for the area of personalized medicine.

2005 to 2009


ALZA, a Johnson and Johnson Company



Principal Scientist


Expert was the lead scientist in the development of a drug/device electrolytic transdermal patch delivery system. He helped overcome many major technical obstacles, including improving the shelf life from six to 18 months and reducing the failure rate from 6% to <50 ppm during this time frame. His responsibilities dealt with outside suppliers to improve their materials and processes, both in chemical and electronic component arenas.

He has filed six patents on the various improvements and technologies in this field.

2001 to 2005


ALZA Corporation



Manager, Specification Development


He was responsible for the specifications and quality of all raw materials, including APIs and excipients, for all of ALZA's development projects. Expert worked closely with the development projects to determine key materials and the requirements for these materials. He was responsible for oversight of all of material specifications in the CMC sections of all of ALZA's drug filings, including authoring the requirements and reviewing dossiers.

1996 to 2001


ALZA Corporation


Analytical Sciences


Principal Scientist


Expert led the physical testing group within Analytical Sciences, which included rheological and viscometric testing, particle size determination, tensile testing test outsourcing, method validations, and method development. He acted as liaison between the group and several development projects.

1990 to 1996


Dionex Corporation



Manager, Suppressor Development


Expert led the efforts in developing the core technology for ion chromatography. He developed technology that dramatically improved the reliability of the core technology, as well as developed IC test methods. He wrote several papers and presented numerous talks on the subject. He also holds six patents pertaining to ion chromatography.

1987 to 1990


Phillips Petroleum Company



Staff Scientist


Expert was in charge of the wet chemical analytical chemistry group. This group performed testing in support of oil exploration, oil and chemical production, and product distribution. He developed numerous new test methods as well as lifted ion chromatography to the forefront of technology in the oil industry.

Career Accomplishments:

Society for Applied Spectroscopy

Professional Appointments

Northern California Section, Society for Applied Spectroscopy, former President, currently Treasurer


Johnson and Johnson Global Standards of Leadership Award

Publications and Patents Summary

Expert holds six patents, one application filed, and an additional five to be filed.

He has written numerous articles and given several outside presentations in his various fields of expertise.

Consulting Services:
Selected Consulting Examples:
  • Expert has worked with a medical device company developing products for personalized medicine. He helped them assess skin adhesive chemistries, bioerodible films, and the chemical systems in their products.
Recent Client Requests:
  • Expert oral dosage pharmaceutical tablet formulation excipient compatibility API degradation pathways phase III trials CMC pharmaceutical formulation development expert for consulting on oral dosage tablet formulation development.
  • Enteric coating expert expert for consulting on Non-medical enteric coating for pellet.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
He has given a deposition once dealing with intellectual property that he developed.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2006 to 2008   France   Expert partnered with an electronic component manufacturer in France, who was a key supplier for his company. He helped them improve the reliability of the components used in his products, including electroplating, stamping, and injection molding improvements. He also developed test methods for them to insure the quality of their parts. He made several trips to their location to fully assess and implement the improvements.
2007 to 2008   China   Expert worked with a printed circuit board manufacturer in Guangzhou who was a primary supplier to his company. He worked with them to improve their manufacturing processes to make the product more robust. He made one trip to Guangzhou.

Language Skills:
Foreign Language   Description
French   Expert can read French, and has rudimentary speaking and writing skills.

Market Research:
Expert often attends meetings to better understand the pharmaceutical marketplace. This is particularly important in product development as one must understand the current reimbursement potential, the competitive arena, and the regulatory direction to develop a product that meets those needs.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert has extensive experience in locating suppliers in the drug arena. These include excipient manufacturers, analytical test labs, and other CROs and CMOs. One of his specialities is in the interaction and management of these suppliers.

He has led several efforts in supplier selection by developing key requirements, translating those requirements to the potential candidates, and setting up metrics to make an unbiased assessment of their capabilities and ability to meet those requirements.


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