SUMMARY

Professional with strong experience in product development, quality engineering, product implementation and process optimization in medical devices, coatings and chemicals. Developed products that are major sales/profit contributors. Formed domestic and international partnerships with customers, manufacturing, quality control, marketing and regulatory affairs to launch new products.

Product development manager

Polymer science

Formulating pigmented coatings

Experimental designs

QA/QC/Validations/Minitab

Regulatory

Reaction scale-up

Coating (Paper and plastic)

Medical device

Trained in Stage Gate

UV/EB curing

Process optimization

Managed analytical laboratory

Spray urea/urethane formulation

PROFESSIONAL EXPERIENCE

Stockmeier Urethanes, Clarksburg, WV Dir. Tech. Serv. & Develop. 2017 - Present

New product development, QC, production optimization.

Johnson & Johnson, Cornelia, GA Quality Engineer III 2016 - 2017

New product validation. Kept project on schedule and received a second extension of initial contract. Test method validations, risk assessment and sampling plans for introduction of a new product. Write protocols and final reports, supervised laboratory work.

Wrote pFMEA and Process Control plans; hazard assessment and remediation plans.

Prepared sampling plans for validation work.

Audited existing processes for compliance.

Hanson Group LLC, Peachtree Corners, GA Polymer Scientist 2009-2016

Developed polyurethane/urea products for casting and coating that are now part of product line. Wrote/managed proposals for contract development contributing 20 % of company revenues. Obtained funding from 3M, Momentive, Lockheed Martin, Oakley and various smaller companies. Collaborated with outside laboratories and Universities for product testing.

Developed spectacle lens material now being sold to a major customer.

Implemented process to manufacture secondary amine now used for automotive coats.

Developed QA program including SOP and STM/Maintained analytical instruments.

Developed epoxy hardener for aerospace customer using DMA, DSC and Rheology.

Wrote SDS for all company products.

Developed sprayable and brushable hybrid urethane systems.

Valchem Technology, Inc.: Atlanta, GA Polymer Consultant 2007-2009

Successfully completed polymer and stent development projects leading to product line additions. Led cost savings initiative to eliminate a manual, off-line, processing step.

Developed hydrogel polymers; led FDA approval, wrote Design Control for FDA

Established QA system for China based aromatic nylon start-up.

Wrote Master Validation Plan and specific validation plans.

Alcon: Chicago/Atlanta, Senior Development Manager 1986-2007

Hired by Wesley Jessen, purchased by CIBA Vision (Now Alcon) making contact lenses. Led continuous development of new products allowing company to maintain dominant market position in the profitable colored lens area. Developed next generation lens polymer and automated production process fueling company’s growth from fifth to third sales rank. Hired, trained and motivated a staff giving five years of double-digit sales growth.

Led international team to develop and implement new hydrogel cosmetic contact lens.

Wrote technical part of groundbreaking FDA submission allowing claims for benefits of UV absorbing contact lenses when a clinical study was not feasible.

Teamed with sales to identify competitive products, alerted patent attorneys, led technical part of law suits. Three companies settled on favorable terms.

Developed and implemented company’s major process/polymer as well as numerous product line extensions leading to continuous sales growth.

Managed an analytical chemistry laboratory to provide data to regulatory for successful FDA submissions.

EDUCATION

PhD Polymer Science Akron University Akron, OH

M.S. Organic Chemistry West Virginia University Morgantown, WV

B.S. Chemistry Duquesne University Pittsburgh, PA

RECENT PATENTS/PUBLICATIONS

1.US Patents 9,248,614 9,102,108 8,920,873 8,883,928 8,147,728 8,079,728 7,888,426 7,288,578 7,279,505 7,255,438

7,201,481 7,049,351 6,132,043 6,169,683 6,322,214

6,482,799 6,634,747 6,649,722 6,955,832 6995.192 6,930,196 5,272,010.

2.Various foreign patents based on issued US Patents.

3.US Pending - Various

4.Novel Hardcoats; Paint & Coatings Industry; Vol 30 (4); 44; 2014.

5.Cosmetic Nanotechnology, ACS Symposium Series, 2005, 46(2), 504.

6.Beauty from Contact Lenses, Polymer Preprints, 2005, 46(2), 504.

7.Invited speaker, 12th symposium on contact lens chemistry and material science, 2001.

8.Spectra of UV-absorbing contact lenses, International Contact Lens Clinic, 27, 65-74, 2000.

9.Accelerated photostability testing. International Contact Lens Clinic, 26, 56-65, 1999.

10.UV T of contact lenses. International Contact Lens Clinic, 25, 142-148, 1998.

11.Colorant Systems for Contact Lenses. J. Polym. Mat.: Sci. Eng., 69,224, 1993.

12.Protein Uptake In Contact Lenses. Contact Lens Spectrum, Sept., 45, 1992.

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