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Manager, Tech Transfer Lohmann Therapy Systems- West Caldwell, New Jersey
Lead the technical transfer and commercialization of pharmaceutical transdermal products. Managed the commercialization of a new fentanyl transdermal drug delivery system.
2007 to Present
2002 to 2006
Lead the development and commercialization of medical device products. Developed in a year, Esteem & Esteem synergy Pediatric product lines. Partnering with Marketing and Neonatal Nurses resulting in unique products for these markets. This leveraged successful expansion into more markets worldwide. Developed and commercialized, within tight cost constraints, Esteem convex, to grow volume for the brand. Developed a new technology which created/invented a new product, Natura Drainable Filter product. Implementation of the design involved also developing key distinct properties for marketing to establish a best in class claim for the product. This resulted in the lead market gaining 3 new key accounts. Developed a new laminated filter and membrane technology for a product commercialization this year, resulting in 50% cost reduction and a significantly improved product. Publications achieved were 1 patent (pending) and a patent application for another.
Principal Scientist-Product/Process Development J & J - Personal Products Worldwide, Skillman, New Jersey
1995 to 2001
Lead the development and commercialization of medical device products and processes. Managed scientists and technicians. Developed o.b. Ultra, to grow volume for the brand. Strong partnering with Regulatory and Clinical resulted in both product approval and new FDA regulation limits for absorbency. Completed concept development of a groundbreaking new material improving competitive advantage. In less than a year, developed and commercialized DYNA-FLEX , a unique new venous leg ulcer bandage system that positioned J&J Medical as a stronger player in advanced wound care. Achieved FDA claims and 60 day 510(k) approval by implementing a psycho sensory test program with input from cross-functional groups (Clinical, Regulatory, Business Development and Marketing). Implemented a new technology which created/invented a new product, an ultra light weight surgical sponge product, MIRASORB , for national launch with 30% cost reduction. Within 10 months developed and commercialized HEMOTROL exodontia sponge, a high profit high volume product. Publications achieved were 1 patent (pending) and a paper on the new venous leg ulcer bandage system. An internal publication included a comprehensive training program for the venous leg ulcer bandage system. Assisted team members in their pursuit of three patents.
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1987 to 1995
As operations leader and product/process development engineer, commercialized 3 new products. Organized market requirements, contract manufacturing, in-house manufacturing and support groups. Developed and commercialized three unique non-woven products: CHIX ULTRA, WORXWELL , and DURAWIPE aerospace wipe. This development broke technology barriers in both binder formulations and fiber forming technologies to achieve new and unique products at current costs. As an area leader on a new technology team, developed a new non-woven technology for J&J. Assisted in development of new computerized laser etching tools, creating new proprietary fabric designs and performance attributes never before possible. This technology increased the market value of The Advanced Materials Company and was sold. Publications achieved were 4 patents.
1981 to 1987
Developed and commercialized 3 new products as product development engineer. Organized market requirements, contract manufacturing, international product support, and internal support groups for commercialization. Commercialized INSTAT , a collagen absorbable hemostat sponge for new surgical uses. FDA approval included unique product claims over competing products. This put J & J as a leader in hemostat technology. Developed and commercialized SURGICEL NU-KNIT , a new oxidized regenerated cellulose product that incorporated state of the art knitting technology. The new unique product helped build new volume in a business that was flat and had high profit margins. Commercialized a new high bulk bandage, SOF-BAND Bulky Bandage, and a new texturizing process technology, in a year. Published an internal white paper for Collagen in Surgical procedures and a hemostat selling aid matrix that covered the top 3 surgeries of all surgical areas from all the clinical studies conducted over the years. Both papers were important to growing the hemostat business and establishing customer acceptance.
1974 to 1981
Progressively increasing responsibilities from process design engineer to the position of project manager of engineering teams in a matrix management environment. Process engineering skills with technologies that include piping systems, heat exchange, filtration, purification, mass transfer, pH control, and blending for food products and pulp processing for paper mills. Major contributions included start up of a new pulp mill, development and commercial equipment design of a new processing system for PURITAN Oil, process and equipment design for JIF Extra Crunchy Peanut Butter, and DUNCAN HINES Peanut Butter Cookies.
EDUCATION
BS Chemical Engineering - 1974 University of Pittsburgh
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CONTINUING EDUCATION
High Performance Composite Fabrics - Clemson University Du Pont Experimental Design- Six Sigma E-Chip Experimental Design- Six Sigma Kepner-Tregeo Problem Solving Techniques Six Sigma FMEA - Six Sigma Statistics Six Sigma Process Excellence/Re-engineering - Six Sigma Conflict Management Design Control
Leadership skills Ethics & leadership, Visionary thinking, Change management, Creativity/Innovation & Strategic Planning
Influence Management