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 Expert  107769

Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)


Available for your Consulting and Expert Witness Needs

New Mexico (NM)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in Manufacturing responsible for introduction of new products (both final dose form and the bulk pharmaceutical chemical). This responsibility included technology, manufacturing business planning, and project management. Other responsibilities included technical troubleshooting for final dose form at three plants, packaging engineering, chemical manufacturing, and central project engineering.

Expert is knowledgeable and up-to-date in current Good Manufacturing Practices (cGMPs), especially as applied to bulk pharmaceutical chemicals. He was Chairman of PhRMA's Bulk Drug Committee, which interfaced with the FDA to present industries views on regulatory issues, primarily cGMP related. As a Director in DuPont and DuPont Merck Pharmaceuticals, Expert led the assessment of about 50 bulk drug suppliers from cGMP, business, management, environmental, and technology perspectives. He also started-up the chemical development function in DuPont. This included initiating cGMPs for a new facility and new group. As a consultant to the pharmaceutical industry, he has made several audits of bulk drug manufacturers, primarily cGMP related.

Expert has written and reviewed many Chemistry, Manufacturing, and Controls (CMC) sections for INDs, NDAs, ANDAs, foreign applications, and DMFs covering both bulk drug and final drug products. He has also written Expert Reports for foreign applications. These FDA and foreign filings cover tablets, parenteral, sterile suspensions, and lyophilized products.

Expert is knowledgeable and up-to-date on the FDA's validation policies and experienced in the design and review of validation protocols, both prospective and retrospective. He has supervised many validations in internal and contractor facilities, including key equipment IQ/OQ, analytical method validations, and cleaning validations leading up to full process validation. Expert has spoken at Penn State University, the Biotechnology Institute, the Center for Validation on process and cleaning validation and validation master plans.

As Senior Director of Technology in DuPont Merck Pharmaceutical Manufacturing, Expert was responsible for the commercial product troubleshooting (process and analytical methods) and transfer of new products from R&D to manufacturing. These new products included ethical and generic drugs in many dose forms (tablets, coated and uncoated, injectable drugs made by both aseptic process and terminal sterilization, and lyophilized products). Expert can answer detailed questions concerning pharmaceutical products and product development, and parenteral product processing.

Expert started-up and ran DuPont Pharmaceuticals Chemical Development Function, which included completing and starting-up new facilities and recruiting a group of dedicated process chemists and engineers to staff the function. During his leadership, many compounds entered development from Medicinal Chemistry (department) and suitable processes were designed to supply the required quantities of drugs for preclinical evaluation or clinical trials. Commercial processes were designed for five NCEs and commercial contractors were selected, evaluated, and qualified. He can explain the details of organic synthesis, organic compound manufacturing troubleshooting, fine chemical production, and yield enhancement.

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pharmaceutical drug

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pharmaceutical product development

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Good Manufacturing Practice

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Current Good Manufacturing Practice

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drug development

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drug processing

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drug regulation

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pharmaceutical manufacturer

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Food and Drug Administration new drug code

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drug product approval

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new drug application

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new drug

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investigational drug

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Chemistry, Manufacturing and Controls

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Food and Drug Administration validation

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cleaning validation

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drug validation

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nonaseptic pharmaceutical process validation

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process validation

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generic drug manufacturing

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generic drug

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pharmaceutical manufacturing

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parenteral product

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parenteral product manufacturing

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parenteral product processing

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parenteral drug delivery

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dosage form

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injectable drug

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bulk pharmaceutical chemical manufacturing

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bulk drug

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organic compound manufacturing

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organic compound manufacturing troubleshooting

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organic compound process development

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fine chemical

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fine chemical production

Throughout Expert's industrial career (28 years), all his positions have been involved in process research and development, manufacturing, and technology transfer from development to manufacturing. All these positions involved interfacing between R&D and manufacturing. His skills have been honed in process and product development, transfer of technology, strategic long range focus in planning and facilities, up-to-date knowledge of pharmaceuticals cGMPs (especially as applies to bulk drugs), and management of contract development and manufacturing firms.

DuPont Pharmaceuticals and DuPont Merck, Expert started-up and managed the Chemical Development function, which developed processes and supplied drug for preclinical and clinical evaluation. Pilot facilities were small and contractors were extensively used to supply intermediates and prepare larger quantities of drug. To meet the internal timelines these contractors had to be carefully chosen and carefully managed. Preaudits were an important part of the selection process. These audits covered cGMP, business, management, safety, technical ability, and environmental issues. At DuPont Merck Pharmaceuticals, Expert's reliance on contractors for bulk drugs continued with over 50 suppliers of commercial products. As Director of Chemical Manufacturing, he began a systemic evaluation and upgrading of these contractors to meet current FDA expectations in which a broad-based audit played a key role. As a consultant, he has continued to audit contractors and assist clients in selecting contractors for bulk drugs and drug products.

Twenty-eight years at DuPont and DuPont Merck Pharmaceuticals at the interface between R&D and Manufacturing has brought Expert in contact with many pilot plants in varying roles. He has managed five pilot plants, ranging from polymers to industrial chemicals to pharmaceutical bulk chemicals. Two multi-million dollar pilot plants were built under his initiation and guidance, one for industrial chemicals and one for pharmaceutical bulk chemicals. The latest was a $50MM multi-purpose pharmaceutical pilot plant for DuPont Merck Pharmaceuticals started-up in 1993.

As head of DuPont Merck Chemical Development, Expert had considerable experience working with contractors that involved technology transfer into their organization for implementation. Internal technology transfer was also a major responsibility for Expert in his role as Senior Director of Technology, in DuPont Merck Pharmaceutical Manufacturing, where bulk drug and final drug product technology was developed in R&D was transferred to Manufacturing for implementation.

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manufacturing process development

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manufacturing process optimization

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manufacturing technology management

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pharmaceutical manufacturing facility auditing

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organic compound pilot plant

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pharmaceutical intermediate

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pilot plant

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pilot plant operations management

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pilot plant process development

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pilot plant scale-up

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pilot plant studying

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technology transfer


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Albuquerque, New Mexico;  and Rio Rancho, New Mexico.

Often requested
with this expert:

Pharmaceutical Technology, Manufacturing, Quality Systems...
Pharmaceutical Manufacturing
Aseptic Process Design, Airflow Visualization, HACCP, PAI...
New Drug Development and Approval

Education:
Year   Degree   Subject   Institution  
1965   PhD   Organic Chemistry   University of Missouri, Columbia  
1961   BS   Chemistry   Missouri School of Mines and Metallurgy  

Work History:
Years   Employer   Title  

1994 to

 

(Undisclosed)

 

Independent Consultant

 

1992 to 1994

 

The DuPont Merck Pharmaceutical Company

 

Senior Director, Technology and Engineering

 

1991 to 1992

 

The DuPont Merck Pharmaceutical Company

 

Director, Chemical Manufacturing

 

1988 to 1991

 

DuPont Corporation

 

Director of Pharmaceutical Planning and Administration

 

1986 to 1988

 

DuPont Corporation

 

Research Manager, Ampligen Development

 

1982 to 1986

 

DuPont Corporation

 

Research Manager, Chemical Development

 

1980 to 1982

 

DuPont Corporation

 

Environmental Manager

 

1978 to 1980

 

DuPont Corporation

 

Production Superintendent, Peroxygen Products

 

Career Accomplishments:
Associations/Societies

Expert is a member of the American Chemical Society, the Drug Information Association, the Parenteral Drug Association, and the International Society for Pharmaceutical Engineering.


Consulting Services:
Recent Client Requests:
  • FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
  • Pharmaceutical manufacturing expert for consulting on controlled release oral solid dosage form manufacture, testing and packaging.
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:
Recent Litigation Client Requests:
  • Expert in FDA litigation for consulting on microbiological contamination of pharmaceuticals.
  • Phamaceutical Technology expert for consulting on glass vial delamination.
  • FDA expert witness for consulting on an atypical antipsychotic..
  • Pharmaceutical manufacturing expert to evaluate manufacturing process and CGMP issues related to a pharmaceutical company's production of a double dosage of certain drugs.
  • Drug formulation expert for consulting on Amifostine.
  • Contract manufacturing expert witness pharmaceuticals for consulting on Trial on pharmaceutical contract manufacturing.
  • Expert in drug development process for litigation case.
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:
Country / Region   Summary
Europe and Japan   Expert has worked with European and Japanese contractors on audits, evaluations, and technology transfer.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert has experience locating vendors of: bulk drug development and pharmaceutical final product development.


 

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