HOWARD R. LEARY, PE, CPP

1775 Pelican Way, Vero Beach, FL 32963

(908)655-6072, howard@hleary.com

SUMMARY OF QUALIFICATIONS

As a principle in an engineering firm I have consulted on package design and automation and managed many large and small packaging development and automation projects. As an experienced manager of technical functions, I have been in responsible control of Package Development, Package Engineering and Manufacturing Engineering for two major consumer goods manufacturers prior to joining an engineering firm. Technical leadership and management skills have enabled me to successfully maintain effective leadership in packaging engineering.

A professional leader, I have been active in the Institute of Packaging Professionals throughout my career and taken many leadership roles, including President. I maintain relationships throughout various categories of the packaging industries.

CAREER HISTORY

HOWARD R. LEARY ASSOCIATES 2008-Present

As an independent consultant, providing advice and services on package design and machinery issues.

• For the launch of a new retail medical device package, developed sealing parameters, wrote physical testing procedures, represented the client in technical dealings with the machine packaging manufacturer and wrote validation protocols.
• Performed a study for package upgrades for a line of veterinary products.
• Performed a study to determine appropriate unit dose packages for reagents in a newly developed diagnostic test kit.
• Wrote validation protocols for a form-fill-seal blister machine.
• Redesigned the sealing method for stand-up pouches to overcome occasional leakage.
• Provided technical guidance for the design and startup of a manufacturing system for a delivery device for cosmetic and medical use, and wrote validation protocols and SOP’s.
• Wrote an IQ/OQ for a unique tablet forming process.
• Created specifications, DQ, FAT, SAT, IQ/OQ for an automatic drug delivery device filling, sealing, labeling and inspection system

LUCIANO PACKAGING TECHNOLOGIES, INC. 1990-2008

An engineering firm specializing in packaging, offering consulting, system integration and machinery development services.

Vice President, Engineering

Perform consulting on package design and automation, manage major projects, manage technical support staff and other business functions, interface with customers, including sales and project coordination.

Packaging Engineering Accomplishments:

General:

· Designed complete new packaging systems for numerous products, including injectable drugs and antibiotics, granular drug and household products, tablets, pre-filled vials, refractory grout, gum base, hamburgers, cleaning products, and other products for various clients.

· Completed consulting projects for numerous clients including packaging process concept development, efficiency and cost reduction studies, feasibility studies, cause of failure resolution, instructional presentations and expert witness testimony.

· Managed major packaging automation projects, including package and machine design, up to seven million dollars in value.

Project Highlights:

· Managed several vision inspection and data handling projects for drug and diagnostic products.

· Developed a unique portable powder filling line for bottles for a prescription drug.

· Re-engineered a sterile operation for plasma bag filling.

· Developed and implemented processes to fill, finish and package a unique injectable rug delivery system.

· Developed and implemented a process for sterile filling of a unique vaccine vial.

· Designed a class 100 aseptic enclosure for a sterile filling machine.

· Developed packaging material design and quality standards to enable maximum line operating efficiency.

· Designed unique new primary and secondary packages for disposable contact lenses. Ameristar and Worldstar were achieved.

· Designed new packages for guitar strings and implemented automated packaging.

· Managed a team of Validation Engineers performing qualifications and studies of packaging machines.

Business Management Accomplishments:

· Implemented an ISO 9001 quality management system, achieved certification under 1994 and 2000 standards, continue as the quality management function.

· Prepare annual stockholder reports and run annual meetings.

· Led the manufacturing efforts on projects with special scheduling needs.

· Sales contact and proposal preparation.

· Management of engineering staff

BOYLE-MIDWAY HOUSEHOLD PRODUCTS, INC. 1986-1990

A division of American Home Products, Boyle-Midway was a major manufacturer of household cleaning products, insecticides and other consumer products.

Director of Packaging

Directed a group of 10 professionals, including manager, engineers and technicians who designed and developed all packages. Work closely with Division Management and Marketing to identify and implement opportunities to increase sales or profits through new packaging strategies.

· Built a highly skilled and motivated Package Development Team with high standards for package excellence and project completion.

· Reduced operating costs by bringing package testing in house.

· Led environmental package development investigations including packages made from recycled plastic and package replacement for source reduction.

· Directed the design of a line of pallet tray packs, which enabled the company to effectively penetrate the Warehouse Club trade.

· Organized the creation of an optimized sprayer bottle that provides greater consumer appeal and satisfaction.

· Sparked the upgrade of existing bottles for a higher quality shelf presentation through in-mold plastic labels.

· Championed and managed the design and development of a miniaturized drain back spout and measuring cap system for detergent bottles.

· Resolved child safety and breakage problems by developing a new bottle for furniture oil.

· Saved material cost by replacing folding cartons with a cellophane wrap.

· Directed package development to support numerous new product launches.

· Initiated several projects that address consumer appeal via cutting edge technology.

PERSONAL PRODUCTS CO. 1972-1986

A Division of Johnson & Johnson, Personal Products is a major manufacturer of feminine hygiene and personal care products.

Manager, Package Engineering 1982-1986

Managed a department responsible for packaging machinery and package development. Helped lead the company into new lower cost and consumer preferred forms of packaging.

· Enabled a major product upgrade by developing automatic folding and bagging of sanitary napkins.

· Engineered automatic collating and cartoning for sanitary napkins.

· Designed and developed an award winning molded package and automated production line for cosmetic wipes.

· Developed a zippered pouch package and production process for cosmetic wipes.

· Developed pallet tray packs for the Warehouse Club trade.

Manager, Equipment Engineering 1978-1982

Managed a group of engineers responsible for automation and trouble-shooting in a manufacturing plant.

· Laid out, designed and implemented a production department for a major new product.

· Automated existing packaging operations.

· Designed and implemented major production department re-layouts to provide capacity for product line extensions and increased efficiency.

· Engineered and installed an automatic scanning and sorting system.

· Improved the department's effectiveness by establishing team relationships.

Senior Packaging Engineer 1975-1978

Responsible for the development of packages and packaging processes. I was the first engineer to specialize in packaging for the compny.

· Converted Modess from folding cartons to plastic wrap.

· Developed a pouch package with dispensing device for cleansing wipes.

Equipment Engineer 1972-1975

Engineered automation and re-layout projects and redesigned production machinery for higher efficiency.

· Automated a multiple line cartoning operation.

· Converted all lines from dextrin glue to hot melt.

NEWARK STEEL DRUM COMPANY 1969-1972

Plant Engineer

Responsible for managing facilities maintenance, designing tools and dies, and supervising maintenance personnel for steel drum manufacturing plant

· Designed and implemented a re-layout and automation project.

HEWITT-ROBBINS, a Division of Litton Industries 1968-1969

Sales Engineer

LINK-BELT, A Division of FMC Corporation 1965-1968

Sales Engineer

EDUCATION AND CREDENTIALS

Professional Engineer, New Jersey License 22436

Certified Packaging Professional (CPP)

BSME (1965) and MSME (1974), Newark College of Engineering (NJIT)

Continuing education coursework in technical and management subjects

PROFESSIONAL AFFLIATIONS

Institute of Packaging Professionals:

· Co-Founder and past President of the New Jersey Chapter

· Co-Founder and Chair of the Validation Technical Committee

· Chair of the Consultant's Council

· Vice Chair of the Technical Council

· Fellow Member

· Member of the Year, 2000

· Vice President, Education

· Executive Vice President, Membership, Education, Finance and Operations

· President

· Chairmen of the Board

· Immediate Past Chairman

· Honorary Life Member

International Society for Pharmaceutical Engineering:

· Chair, Packaging Curriculum Committee