PROFESSIONAL STRENGTHS

 

A mature individual with experience in biopharmaceutical manufacturing, assay and process development ,technology transfer, training, and technical writing and editing.  Established “hands-on” laboratory and manufacturing process investigator. Experienced and current with cGMP/GLP requirements and manufacturing process validation. More than 120 publications in professional journals, several books and multiple patents. Known for several major improvements in manufacturing.   Editor-in-Chief of international internet journal in genomics and proteomics .

 

PROFESSIONAL OBJECTIVE

 

Consulting activities utilizing accumulated expertise in education, scientific writing and editing, biopharmaceutical research/development, product development,  and manufacturing.

 

SUMMARY OF QUALIFICATIONS

 

R & D: basic research, product development, process development, advanced development, product design, product testing/manufacturing, engineering liaison, compliance, test procedures, project management, technology evaluation, technology and process transfer

Manufacturing & Operations: assay development, process development, assay validation, process validation, technology and process transfer

Human Resources: training, orientation, conflict resolution

Education:  Self-instructional programs, classroom teaching, evaluation, continuing education, 

Communication: Technical writing, scientific writing, editing

 

PERSONAL STRENGTHS/ATTRIBUTES

 

An action person	Establishes clear lines of communication
Projects enthusiasm	Broad-based experience
Ran seminars & conferences	Won loyalty of others
Project management experience	Seasoned competitor
Gives 100% at all times	Skillfully delegates duties
Skilled, versatile writer	Natural mentor

 

 

EDUCATION AND CONTINUOUS TRAINING

Post-Doctoral – Rockefeller University, New York, NY

Ph.D. (Biochemistry) – University of Washington, Seattle, WA

BS (Chemistry) – Pacific Lutheran University, Tacoma, WA

 

Click Here for a Complete Curriculum Vitae

 

 

PROFESSIONAL EXPERIENCE

Consultant Practice - Chapel Hill, North Carolina (2000-Present)

Independent consultant in biotechnology with both start-up and mature organizations

• Consultant to start-up biotechnology company. Results: Successful manufacture of a generic biotherapeutic with market value of $25 million.
• Restructured and validated manufacturing process for company. Results: Overall increase in revenue of $20 million.
• Identified unique fuel source for client’s new engine. Results: Potential market revenue of $100 million a year.
• Editor, Biotechnology and Applied Biochemistry, markedly increased impact factor with change in editorial focus
• Editor, Internet Journal of Genomics and Proteomics

 

DIRECTOR OF SCIENCE AND TECHNOLOGY DEVELOPMENT – Baxter Healthcare

Duarte/Glendale, CA (1992 – 2000)

New product development, expert reports for regulatory affairs, management of extramural research program, protein characterization, new technology acquisition, process validation, in-house training for manufacturing personnel, development of in-house continuing education, GMP/GLP

• Created a unique process for viral-inactivation biotherapeutics using variable frequency microwaves. Results: Obtained U.S. patent, large market advantage with respect to product safety and potential market advantage of $10 million.
• Developed a purification process that was required for the manufacture of a fibrin sealant product. Results: Product now on market with a $50 million yearly value.

 

DIRECTOR OF TECHNOLOGY DEVELOPMENT – Baxter Healthcare

Hayward, CA (February 1991 – December 1992)

• Developed manufacturing process requiring the presence of a potentially toxic chemical (methotrexate). Results: Market value of $1 million a year.
• Developed a purification process for biologicals. Results: A cost-reduction of $500,000 yearly.

 

PROFESSOR – University of North Carolina at Chapel Hill

Chapel Hill, NC (1968 – 1991)

Education, basic research, basic research management, interdisciplinary program management, continuing education (on-site and off-site), program evaluation, innovations in classroom instruction

• Responsible for installation of first computers for fiscal management. Results: 100% increase in productivity and maintenance of staff at current level.
• Organized international meeting on heparin for over 200 participants. Results: A book containing the proceedings and publicity were responsible for $500,000/year in increased research funding.
• Pursued additional extramural research funding. Results: During tenure, obtained over $3 million in funding.

 

OUTSTANDING REFERENCES PROVIDED UPON ESTABLISHMENT OF MUTUAL INTEREST