Dennis G. McVey

*** ********** *****

Leola, PA *7540

717-***-****

Summary

Chemical Engineer with experience and training in Process Engineering, Process Development, Formulation Development and Scale-Up, Troubleshooting, Project Management, Equipment Qualification and Process Validation within FDA Regulated Industries. Green Belt Certified in Design for Six Sigma (DFSS). PROFESSIONAL EXPERIENCE

Johnson & Johnson Consumer Products

2012-Present

Principal Scientist, TA/SMP

Responsible for Technical Assurance (TA) and Support to Marketed Products

(SMP) for Aveeno, Bengay, Desitin, Johnson’s Baby Oil representing various oils, emulsions, and ointments/pastes within the Johnson & Johnson (J&J) Consumer Products product portfolio. Responsible for resiting products to internal (J&J) manufacturing sites for Cost Improvement, scaling up New Product Introductions using internal Pilot Plant facilities, Reformulating existing products, qualifying new Raw Materials and new suppliers, Troubleshooting and resolving formulation issues, supporting existing manufacturing processes and implementing process improvements. In addition, responsible for coordination and execution of Pilot Batches, Manufacturing Trial Batches, Providing Validation Support, and Automation Batch Support. In addition, responsible for manufacturing process compliance to Batch Records and Automation Systems/Electronic Batch Records and Safety Improvement Programs. Nice-Pak Products

2009-2012

Director, Strategic Product Development

Responsible for providing strategic direction, Program Management and Project Management for $500MM business in wet wipes. Lead Speed to Market initiative with the objective to launch the right products faster via Stage Gate Product Development Process. Specializing in the development injection molded parts, brackets, and components. Developed a new branded program along with improving margins and sales of existing Private Label and Branded wipes through implementation of cost savings and innovation programs. Responsible for improving the sustainability of products and packaging. W.L. Gore & Associates

2008-2009

Senior Process Engineer

Divisional Process Engineer responsible for commercialization of products within Industrial product division of W.L. Gore & Associates. Drive launch of products from stage 2 development through implementation utilizing sound Project Management practices. Lead final development and scale-up. Responsible for Equipment selection, Equipment Qualification and Validations on injection molding and filtration products. Major emphasis on injection molding selection, equipment and tooling selection, development and qualification. Responsible for Failure Modes Effects Analysis (FMEA) and Process Development of new platform products.

Covidien (formerly Tyco Healthcare)

2004- 2008

R&D Section Manager

Responsible for innovation, project implementation and on going support of the absorbent hygiene products representing sales of $350MM. Lead an R&D Product Development team in utilization of Product Development Stage Gate Process (PDP). Manage group leader and up to eight scientists and technicians with a $1.2MM budget to achieve organic sales growth and margins of the business unit. Provide technical support to the manufacturing unit. R&D Group Leader/Staff Engineer

Responsible for development of Design File History (DFH), Technology Transfer to Manufacturing and product/process support throughout the product life cycle. Manage portion of an R&D Group focused on implementing Product Development Process (PDP) to launch new products. Responsible for allocating and monitoring team resources for various absorbent hygiene projects. Also responsible for leading product development project teams as Core Team Leader (CTL) utilizing Design for Six-Sigma (DFSS) Green Belt and Project Management training.

Wyeth Research

2001- 2003

Research and Development, Formulation and Vaccine Delivery, Sr. Research Scientist

Responsible for leading Process Development; Scale-up, Equipment Qualification and Cleaning & Process Validations. Lead Technology transfer of new processes to both internal manufacturing and to Contract Manufacturer. Drove Process optimization and alternative formulation development. Johnson & Johnson

J&J/Merck Consumer Pharmaceuticals Company.

1993 – 2001

Research and Development Technical Services, Research Scientist Responsible for Process Development, Product Development and Process Engineering for both Liquid (suspensions) and Solid Dosage (chewable and swallowable tablets & caplets) forms of OTC Pharmaceutical franchise. Process Owner of Solid Dosage unit operations including blending (powder to powder and liquid to powder), granulation (roller compaction and fluid bed), tablet and caplet film coating, and gelatin coating (geldipping) processes. Equipment selection and Qualification (IQ/OQ/PQ); Process Validations; Cleaning Validations.

Developed, validated and implemented various formulation changes including changes in dosage form, active composition (strength), flavor, and color; Researched and Developed fast-dissolving technologies, and novel granulation technologies.

Scale-up of process and equipment; equipment qualifications (IQ/OQ/PQ) and process validation and optimization; Cost Improvement projects; Development and validation of alternative sources of raw material changes of both active drugs

(API’s) and excipients; Development and validation of chemical cleaning agents and cleaning processes. Technology Transfer from R&D to Manufacturing. ETHICON, Inc. (J&J)

May 1989

R&D Technology Support/ Senior Engineer engaging in process improvements, product development and technology transfer from R&D to Operations of polymer processing for sterilized absorbable surgical sutures. Assigned to train Technical Services Engineers and Supervisors in Kepner- Tregoe Troubleshooting techniques. Performed basic and applied research within Product Development.

Personal Products Company (J&J)

February 1988

Technical Service Engineer initiating and implementing process control, process improvements and cost reductions. Also established validated processes within areas of involvement. Support operations Engineering projects. Johnson Matthey Corporation

1986 -1988

Process Engineer establishing process control, process improvements and cost reductions in the Manufacture of epoxy resins and catalytic converter technologies.

EDUCATION

Drexel University, Phila., PA

Bachelors of Science in Chemical Engineering

Rutgers University, New Brunswick, NJ

Classes taken toward M.S. in Chemical Engineering

CERTIFICATIONS

Active Leadership Training

Leadership Effectiveness Training (LET)

Design For Six Sigma (DFSS) Green Belt Certified

Design For Six Sigma (DFSS) Black Belt In-Progress Kepner-Tregoe Certified Instructor in Project Management American Society for Quality (ASQ) Certified Quality Engineer Kepner-Tregoe Certified Instructor: Problem Solving and Decision Making AWARDS

Johnson & Johnson Quality Award

Tyco Healthcare/Covidien Everest Award (2)

PATENTS

Two patents for Absorbent Hygiene Products

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