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 Expert  725868

Expert in Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry

Available for your Consulting and Expert Witness Needs

Montana (MT)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11.

21 CFR Part 11


Food and Drug Administration compliance


Food and Drug Administration regulation


Food and Drug Administration validation

He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.



Internet marketing


service marketing


technical marketing

He has developed branding campaigns and helped organizations define and communicate their brand.



marketing brand management


marketing communications



He has managed the operations of businesses including financial management and personnel management.

business management

He has held positions as the director of operations in organizations.

business operations


project management

He has helped organizations develop new business strategies and strategic plans by acting in the role of a facilitator and business plan author.

business strategy


marketing mix


strategic planning


strategic research planning

He has conducted competitive intelligence for numerous companies. This research was used to develop marketing plans and business plans.

competitive intelligence

He has facilitated the development of strategic plans. He has been the primary author of strategic plans.

corporate strategic planning

He is knowledgeable of the current Good Manufacturing Practices. He had developed quality systems in compliance with cGMP's. He has performed compliance audit with respect to cGMP's.

Current Good Manufacturing Practice


Good Manufacturing Practice

He has segmented the customers for both product and service companies.

customer segmentation


gap analysis


market assessment


market development


market forecasting


market positioning


market research


market trend




marketing database

He has developed direct mail campaigns that have successfully driven revenue growth.

direct mail

He is familiar with the FDA regulations for hard surface and high-level disinfectants. He has helped developed new testing service for these markets.

disinfectant Food and Drug Administration regulation

He is educated in entrepreneurship at the MBA level. He has developed business plans for start-up companies. He has presented business plans to investors.




Show Secondary and Basic Areas of Expertise

Year   Degree   Subject   Institution   Honors
2000   MBA   Marketing   University of Washington  
1991   BS   Mechanical Engineering   University of Portland   Magna Cum Laude

Work History:
Years   Employer   Department   Title   Responsibilities

2008 to





President/Senior Consultant


He is the owner and senior consultant of a consulting firm working serving the Life Sciences industry with compliance, quality assurance, marketing and strategy consulting.

2005 to 2008


Computer Compliance/ProPharma Group



Director of Operations


He recruited, hired and supervised administrative, development, engineering, marketing and sales staff for a technology services and software development company. He wrote marketing plans, managed advertising campaigns and developed marketing materials. He managed client, partner and vendor relationships. He managed the company's financial health. He led the strategic planning for an IT services business unit. He developed project management program and training curriculum.

2007 to 2007


Montana State University


College of Business




He developed and taught curriculum for a 400-level technology marketing course at an accredited university. The course was focused on developing marketing strategies for new technology products and services.

2002 to 2005





President and Senior Consultant


He owned and operated a consulting firm serving the Life Sciences industry with compliance and quality assurance consulting. He developed and maintained relationships with clients and partners. He grew the business 20% each year.

2001 to 2002


ILX Lightwave, Bozeman



Product Manager


He managed $4 million instrumentation product line in the fiber optics industry with profit and loss responsibility. He developed and successfully launched three direct marketing programs that increased product line sales by 10%. He wrote two new product plans that were approved by executive management to begin product development of new instruments.

1996 to 1998


Puget Sound Blood Center



Program Manager


He developed and implemented quality programs for equipment and process qualification throughout the organization. He successfully trained sixty staff to follow the programs that increased compliance with FDA standards.

1994 to 1996


ZymoGenetics, Inc.



Quality Assurance Engineer


He raised level of FDA compliance within a manufacturing pilot plant by developing and implementing an equipment qualification program. He trained staff on FDA compliance.

1992 to 1994


Skyland Scientific Services, Inc.



Project Manager


He managed $1 Million consulting project at a biotechnology company in the Bay Area. He supervised project staff. He provided compliance consulting to the Life Sciences industry.

Career Accomplishments:




Selected Publications and Publishers  
 - Compliance Focus  

Consulting Services:
Selected Consulting Examples:
  • Provided marketing and business development consulting for testing and clinical trials service provider, BioScience Laboratories.
  • Provided validation and quality assurance consulting for biotech manufacturing facility, Amgen Washington.
  • Provided validation and quality assurance consulting for pharmaceutical manufacturing facility, Allergan in Irvine, CA.
  • Provided validation and quality assurance consulting for pharmaceutical manufacturing facility, Alkermes in Wilmington, OH.
  • Provided business development and marketing consulting to a Project Management consulting firm, Versatile Company in Seattle, WA.
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:
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
2005 to 2005   Singapore   Performed GMP audit for medical device manufacturing facility owned by Hoya Medical.

Market Research:
He actively tracks the trends of the generic drug, topical drug, disinfectant markets. He has developed business strategies to be a service supplier in each of these markets.

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:

Project Management for Consulting Firms, cGMP Compliance for BioTechnology Manufactyuring

Supplier and Vendor Location and Selection

He managed vendor contracts and performed quality audits of potential vendors.

Other Skills and Services

He is an expert in developing quality compliance plans and business strategy plans.


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