Expert Details
Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
ID: 725868
Montana, USA
He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.
He has developed branding campaigns and helped organizations define and communicate their brand.
He has managed the operations of businesses including financial management and personnel management.
He has held positions as the director of operations in organizations.
He has helped organizations develop new business strategies and strategic plans by acting in the role of a facilitator and business plan author.
He has conducted competitive intelligence for numerous companies. This research was used to develop marketing plans and business plans.
He has facilitated the development of strategic plans. He has been the primary author of strategic plans.
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.
He has segmented the customers for both product and service companies.
He has developed direct mail campaigns that have successfully driven revenue growth.
He is familiar with the FDA regulations for hard surface and high-level disinfectants. He has helped developed new testing service for these markets.
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.
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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2000 | Degree: MBA | Subject: Marketing | Institution: University of Washington |
| Year: 1991 | Degree: BS | Subject: Mechanical Engineering | Institution: University of Portland |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to Present | Employer: Undisclosed | Title: President/Senior Consultant | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2008 | Employer: Computer Compliance/ProPharma Group | Title: Director of Operations | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 2007 to 2007 | Employer: Montana State University | Title: Instructor | Department: College of Business |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 2002 to 2005 | Employer: The Mercury Group | Title: President and Senior Consultant | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2002 | Employer: ILX Lightwave, Bozeman | Title: Product Manager | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1998 | Employer: Puget Sound Blood Center | Title: Program Manager | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1996 | Employer: ZymoGenetics, Inc. | Title: Quality Assurance Engineer | Department: |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1992 to 1994 | Employer: Skyland Scientific Services, Inc. | Title: Project Manager | Department: |
Responsibilities: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. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2005 to 2005 | Country / Region: Singapore | Summary: Performed GMP audit for medical device manufacturing facility owned by Hoya Medical. |
Career Accomplishments
| Associations / Societies |
|---|
| ASCPT, ISAR |
| Licenses / Certifications |
|---|
| EIT |
Additional Experience
| Training / Seminars |
|---|
| Project Management for Consulting Firms, cGMP Compliance for BioTechnology Manufactyuring |
| Vendor Selection |
|---|
| He managed vendor contracts and performed quality audits of potential vendors. |
| Marketing Experience |
|---|
| 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. |
| Other Relevant Experience |
|---|
| He is an expert in developing quality compliance plans and business strategy plans. |
Fields of Expertise
21 CFR Part 11, Food and Drug Administration compliance, Food and Drug Administration regulation, Food and Drug Administration validation, advertising, Internet marketing, service marketing, technical marketing, branding, marketing brand management, marketing communications, promotion, business management, business operations, project management, business strategy, marketing mix, strategic planning, strategic research planning, competitive intelligence, corporate strategic planning, Current Good Manufacturing Practice, Good Manufacturing Practice, customer segmentation, gap analysis, market assessment, market development, market forecasting, market positioning, market research, market trend, marketing, marketing database, direct mail, disinfectant Food and Drug Administration regulation, entrepreneurship, mentoring, investigational drug procedures, abbreviated new drug application, market, advertising perception survey, customer satisfaction, business development, Internet advertising, trade show, FDA food labeling regulation, life-cycle cost, generic drug, consumer product marketing, antiviral drug, Food and Drug Administration cosmetic regulation, value analysis program management, Food and Drug Administration drug packaging regulation, new product market survey, new product design, Food and Drug Administration, drug regulation, software project management, Food and Drug Administration new drug code, FDA medical device regulation, investigational drug, Good Laboratory Practice