Expert Details

Expert in cGMP Coatings, Pharmaceutical, Dietary Supplements, Adhesives, Die Cutting, Security Holograms, Printing, Operations Management Metrics and Strategy, and Materials

Expert ID: 727745 Pennsylvania, USA

Request Expert

Expert has worked in custom manufacturing – polymerization, mixing, coating and converting of cGMP adhesive and laminates - as a process engineering manager. In this role he lead operations and engineering on the corporate Business Strategy Team (BST) asserting direction for each division sales plan, budget, strategy, and quarterly goals; managed the outsourced manufacturing of all polymerization, mixing, coating, and converting of products to increase capacity, cash flow, reduce capital outlay, improve on time delivery, yield, maximize total value, and product margin; as well as assisted process engineers and operations associates to successfully develop and manufacture cGMP food grade oral dissolvable films, medical device, pharmaceutical transdermal drug delivery, industrial, electronic adhesive products, and silicone/ fluoropolymer release liners. He also completed stage gate product/process development projects increasing revenue by over $7MM and instilled accountability and discipline to product development and process improvement utilizing a stage gate development and statistical Six Sigma program.

Expert has been involved with margin improvement programs. He has developed and commercialized adhesive products which required regulated clean controlled manufacturing environments as well as conductive transfer and repulpable adhesive products. He executed the factory acceptance, installation qualification, and startup of new cGMP extrusion slot die coating, mixing technology, and key products to for his firm's Limerick, Ireland (green field site). Expert's expertise includes fixed and adjustable lip slot die extrusion, reverse roll, gravure converted products, rotary die cutting and slitting technical service.

While at International Paper Company, he was a production manager and managed the thermoplastic and thermoset molded industrial plastics department.

He managed Operations a vitamins, mineral, supplement 21CFR 111 registered facility and had instituted responsible effective process improvement and motivating people to achieve measurable key performance results. Expert specified, developed and installed manufacturing processes improvements including cGMP mixing, polymerization, coating and printing processes.

At OpSec he have lead North American Operation including the startup, relocated and consolidated multiple manufacturing sites. He successfully recruited and built professional teams to manage manufacturing, supply chain, engineering, quality, EH&S and facilities. He has instituted effective TPM programs achieving results including lean/ value stream mapping with material and process cost savings ($3.1million). Expert also enjoys developing people, as well as systematic improvements to quality systems and business systems including ISO, product development processes, as well as ERP business systems.

Electochemical plating of nickel
Chemical Vapor Deposition
Plasma coating and cleaning
EMI Shielding
Electro chemical processing.

Product and Process Design - formulation, interaction and process equipment specifications/RFQ through validation.
Manufacturing Solution and Troubleshooting (Six Sigma)
Manufacturing location selection and relocation planning.
Engineering capital project management

Marketing and Business Plans
• Serve clients as an operations and engineering management consultant for the medical device and Pharmaceutical industries. Currently working on manufacturing and quality systems for medical device woven and braided in situ and wound care products.
• Develop products and manage continuous improvement, process optimization and capitals projects for paper, film and adhesive coating and converting. Currently working as project manager on a large facility relocation and expansion (>$10 million). This includes novel coating and atmospheric plasma surface energy technologies.
• Identify opportunities and implement cost savings and quantify with financial cost benefits and metrics.
• Developing marketing and business plans for security printing and converting company as Director of Marketing.

Expert may consult nationally and internationally, and is also local to the following cities: Philadelphia, Pennsylvania - Allentown, Pennsylvania - Reading, Pennsylvania - Bethlehem, Pennsylvania - Lancaster, Pennsylvania - Camden, New Jersey - Vineland, New Jersey - Wilmington, Delaware - Baltimore, Maryland - Alexandria, Virginia

Request Expert

Education

Year Degree Subject Institution
Year: 1994 Degree: BS Subject: Chemical Engineering Institution: University of Maryland

Work History

Years Employer Title Department Responsibilities
Years: 2020 to Present Employer: Undisclosed Title: Director of Operations Department: Operations Administration Responsibilities: A $56 million special agricultural solutions division within a larger Corp.

(EPA, Dept of Agriculture certified site)
• Manage Operations including, EHS&S, Manufacturing, Quality, Supply Chain, Customer Service, Engineering and Product Development.
• Operation Vision and Guiding Principles and facility key performance indications and goals.
• Continuous improvement including 6S and Introduction to Lean implementation. Visual management boards, measuring Safety, Quality Delivery and Production rates and OEE%.
Years: 2018 to 2020 Employer: Altium Packaging - previously Consolidated Container Company Title: Plant Manager Department: Plant Administration Responsibilities: • Our facility achieved the Quality Excellence award
• Increased EBITDA by $3 million over 2018 forecast. Increased capacity and throughput by 13% without increasing head count. This enabled more sales, commercial development runs and increased cash flow results.
• Hired 12 new employees to handle the growth for 2019. Very low turnover supporting positive culture and guiding principles.
• Successful commercial launch of new DuraLite gallon and half gallon bottles. Running lines 24x7 with 95% utilization and average OEE 82%.
• Successfully manage the largest food and beverage bottle site on the east coast US market. Operations, Engineering and Facilities overall P&L responsibility.
• Maintain great customer and Dairy relationships with very good quality and customer service.
• FDA and Dept of Agriculture audit in 2019 was very successful with no findings. Maintained Grade A rating.
• Continuous improvement programs $0.5 million savings including OEE improvements, cycle time reduction and increased material yield.
• Consolidated Production System leader for Total Productive (Autonomous) Maintenance programs and employee training and process ownership.
• Develop products and manage continuous improvement, process optimization and capitals projects.
Years: 2016 to 2017 Employer: Church and Dwight York Title: Senior Operations Manager Department: Vitamins, Minerals, Supplements Responsibilities: Senior Operations Manager, Vitamins and Mineral (FDA cGMP regulated dietary supplement site)
• Responsible for $26 million budget Operations, Engineering and Facilities P&L gummy vitamin manufacturing, bottling, packaging and distribution plant with >$500 million international sales. Lil Critter and VitaFusion brands are market share leaders.
• Largest manufacturing and distribution facility in North America 1.1 million square feet.
• Continuous improvement programs $2.5 million savings including OEE improvements and material process yield.
• Increased capacity by 23% by enabling changeover reduction by and CIP cleaning validation. This enabled more sales, development runs and launch of new supplemental fact products (NSF).
• FDA audit in 2018 was very successful with no findings.

Expert currently manages Operations a vitamins facility and has instituted responsible effective process improvements and motivates people to achieve measurable key performance results.
Years: 2012 to Present Employer: Undisclosed Title: President Department: Engineering and Operations Responsibilities: York, PA (2012- Present)

• Founder and Owner. Responsible for P&L of own consulting business.
• Serve clients as an operations and engineering management consultant for the medical device and Pharmaceutical industries. Currently working on manufacturing and quality systems for medical device woven and braided in situ and wound care products.
• Develop products and manage continuous improvement, process optimization and capitals projects for paper, film and adhesive coating and converting. Currently working as project manager on a large facility relocation and expansion (>$10 million). This includes novel coating and atmospheric plasma surface energy technologies.
• Identify opportunities and implement cost savings and quantify with financial cost benefits and metrics.
• Developing marketing and business plans for security printing and converting company as Director of Marketing.
Years: 2007 to Present Employer: Undisclosed Title: Director of Operations, Plant Technical Manager Department: General Management Responsibilities: Security printing, converting and liquid crystal coating -- brand protection, government high security and banknote applications.

Plant and Technical Manager (February 2007 – Present)

• Responsible for operations profit and losses including product quality, material yield, on time delivery and throughput optimizing operating profit.
• Empower and develop team members to create and achieve production goals, track process efficiencies and losses (KPI).
• Quantified $3.1M in annualized margin improvement initiatives and accountability for actual product costs to drive Process Engineering priorities. >$1.5 million in actual material and labor savings YTD.
• Design and initiated a formal stage gate product development process with a cross functional team of R&D and Market facing groups in compliance with cGMP and ISO 9001. Production capacity and material planning is forecasted through this pipeline funnel.
• Achieve results through lean transformation using 5S, Quick Changeover, and Kaizen projects for optimum organization and quality throughput. Manufacturing cycles have been reduced < 50%, which actually reduced waste.
• Responsible for plant safety, process safety management (PSM) programs with 2009 overall TIR <0.5.
• Actively promote OpSec brand protection customers and government agencies on the benefits of OpSec technology, products and services.
• Use six sigma data analysis techniques to drive continuous improvement and reduced variation quality errors. This has reduced spoilage and material waste contributing to the large cost saving results.
Years: 1998 to 2007 Employer: Adhesives Research Incorporated Title: Process Engineering Manager Department: Medical and Industrial Responsibilities: Adhesives Research Incorporated Glen Rock, PA (ISO 9001,cGMP FDA registered site)
Custom manufacturing – polymerization, mixing, coating and converting of cGMP adhesive and laminates

Contract Manufacturing and Process Engineering Manager, (October 1998 – February 2007)

• Lead operations and engineering on the corporate Business Strategy Team (BST) asserting direction for each division sales plan, budget, strategy, and quarterly goals.
• Manage the outsourced manufacturing of all polymerization, mixing, coating, and converting of products to increase capacity, cash flow, reduce capital outlay, improve on time delivery, yield, maximize total value, and product margin.
• Empowered process engineers and operations associates to successfully develop and manufacture cGMP food grade oral dissolvable films, medical device, pharmaceutical transdermal drug delivery, industrial, electronic adhesive products, and silicone/ fluoropolymer release liners.
• Successfully completed stage gate product/process development projects increasing revenue by over $7MM. Instilled accountability and discipline to product development and process improvement utilizing a stage gate development and statistical Six Sigma program.
• Initiated and completed margin improvement programs resulting in sustained $1.3MM annualized savings.
• Developed and commercialized ARclearTM optically clear display adhesive products using regulated clean controlled manufacturing environments as well as ARcladTM conductive transfer and repulpable adhesive products.
• Executed the factory acceptance, installation qualification, and startup of new cGMP extrusion slot die coating, mixing technology, and key products to Adhesives Research, Limerick, Ireland (green field site).
• Solved manufacturing challenges involving fixed and adjustable lip slot die extrusion, reverse roll, gravure converted products.
• Communicated with customers to solve product and processing challenges including rotary die cutting and slitting technical service and potential new market development contributing to over $100 M in sales.
Years: 1994 to 1998 Employer: International Paper Company Title: Production Manager Department: Paper and Plastic Products Responsibilities: International Paper Company

Production Manager, Hampton, SC ISO 9002 Certified (June 1997 – September 1998)

• Managed the thermoplastic and thermoset molded MicartaTM industrial plastics department. Directly responsible for the assembly, plastic molding, finishing and packaging operations.
• Empowered the team members to achieve aggressive production goals, track process efficiencies and losses.
• Responsible for the improving quality and customer service.
• Provided technical expertise to the bulk resin production, treating and molding of epoxy, phenol, silicone and melamine products.

Project Manager ARmored Protection (ARP) Paper Coatings: Responsible for design, startup, and optimization of the new coating operation. Developed new high performance specialty decorative plastic molded products.

• Managed the mixing preparation and new coating operation areas. Responsible for allocating new raw materials, chemical formulas, and coating specifications.
• Developed and optimized the resin chemical formulations. Statistically designed optimization experiments (DOE) to setup and optimize the coating process variables.
• Managed the trouble-cause-correction program: certified Kepner-Tregoe instructor. Find the true cause of problems with analytical troubleshooting and prevention.

Process Engineer and Production Supervisor, Odenton, MD (June 1994- June 1997)

• Responsible for the resin mix room, coaters and print storage room production areas. Initiated statistical control of the resin/paper coating process and the production chemical formulations.
• Supervised engineering interns for next generation resin chemistry and the optimization of coating process.
• Provided shift supervision in coating, treater and assembly production departments.
• Technical marketing and customer support: Communicated and visited with key customers and help design technical/marketing brochures.
• Completed a $458,000/yr resin raw material savings project, which also streamlined the treating process by 43%.
• Developed resin coating formulations and key partnerships with resin and paper suppliers which improved NevamarTM high-pressure plastic laminate.
• Represented International Paper and NevamarTM HPL products on the decorative laminate advisory
technical committee of the National Electrical Manufacturers Association (NEMA) to collaborate with industry representatives on the ANSI/NEMA LD-3 technical standard for 1995.
• Supervised technicians and lead the training efforts of the laboratory research/testing equipment such as Dynamic Mechanical Thermal Analysis, Differential Scanning Calorimetry, HPLC, and NEMA LD-3 testing equipment.

Honors & Awards: • International Paper, Circle of Excellence Award

Government Experience

Years Agency Role Description
Years: 1990 to 1993 Agency: Department of Defense Role: MWR/ Engineering Technician Description: Golf Course and LOVA plant technician

International Experience

Years Country / Region Summary
Years: 2001 to 2007 Country / Region: Limerick, Ireland Summary: He had responsibility for product and process scale up at the Adhesives Research, Limerick Ireland facility. The cleanroom optical and electronic adhesive product commercialization was successful.
Years: 2009 to Present Country / Region: Manaus, Brazil Summary: He successfully developed and trialed a new security solution with this customer.
Years: 2009 to Present Country / Region: Warsaw, Poland Summary: He successfully developed and trialed new cost effective materials to this customer.
Years: 2009 to 2015 Country / Region: New Castle, UK Summary: OpSec Security Inc. UK facility technical product transfer.
Years: 2013 to Present Country / Region: Toyama, Japan Summary: Pharmaceutical client consulting project
Years: 2014 to Present Country / Region: Matomoras, Mexico Summary: Automotive client consulting project
Years: 2014 to Present Country / Region: Quebec, Canada Summary: 5 roll toll coating operation

Career Accomplishments

Associations / Societies
AICHE
Licenses / Certifications
Six Sigma Black Belt
Lean Manufacturing
Total Productive Maintenance
Awards / Recognition
Honors; Awards:
• International Paper, Circle of Excellence Award,
• 6 sigma black belt
• TPS Lean Manufacturing
• Tau Beta Pi, National Engineering Honor Society
• National Eagle Scout Association

Additional Experience

Training / Seminars
Expert has offered a seminar at the Shapiro Negotiating Institute. He has also taken the PTI cGMP Root Cause Analysis and Corrective and Preventative Action (CAPA).

EGMT Graduate Course, Organizational Behavior for Engineering Management, George Washington University
EGMT Graduate Course, Quantitative Methods for Management, George Washington University
International Paper Company, Kepner-Tregoe RCA Leader Development Institute (LDI), Cordele, GA.
International Paper Company, Six Sigma Statistical Design of Experiments, (Process Development and Optimization)
International Paper Company, Six Sigma Statistical Data Analysis, Odenton, MD.
International Paper Company, Introduction to Six Sigma Statistical Concepts, Ticonderoga, NY.
International Paper Company, Rapid Change- Business Communication, Odenton, MD.
WatersTM HPLC Preventative Maintenance Pumps, Valves, & Injectors, Boston, MA.
ACS High Pressure Liquid Chromatography Theory and Practice, Virginia Tech, Blacksburg, VA.
Rheometric Scientific DMTA Operations, Applications, and Preventative Maintenance, Odenton, MD
Vendor Selection
Expert has extensive experience specifying cost-effective film, paper, and adhesive tape raw materials.

Expert has a niche for writing specifications and supply/pricing agreements. His project management skills achieve real results, saving millions of dollars year over year.
Marketing Experience
Expert is experienced in cost analysis and in operations/production key performance indicators.
Other Relevant Experience
Expert is highly experienced in the following: Production management, lean manufacturing, six sigma, stage gate product and process development.

Fields of Expertise

transdermal patch, slot fed die coating, adhesive application process, adhesive compounding, adhesive curing, adhesive manufacturing, adhesive tape-coating material, automotive adhesive, clean room coating material, coated polymer film drying, coating material specification, coating technology, electrically conductive adhesive, flexographic coating process, pressure-sensitive adhesive, rubber adhesive, silicone adhesive, skin adhesive tape, solvent adhesive, microbiological food vitamin analysis, vitamin, fat-soluble vitamin, vitamin analysis technique, FDA 21CFR 11 compliance, Food and Drug Administration compliance, Food and Drug Administration drug packaging regulation, FDA food labeling regulation, FDA electronic record, lean six sigma, six sigma quality, advanced process control, process capability study, chemical-process flow chart, chemical process troubleshooting, chemical engineering, electrochemical process, electrochemical process material, electrochemical processing, gas plasma, plasma cleaning, electromagnetic interference filter, electromagnetic shielding process, assembly, printing plant layout, two-part adhesive, coating filler, foam coating material, ceramic adhesive, corrugating adhesive, low-solvent coating material, electrically conductive floor coating, drop-on-demand ink-jet printer, holographic polymer, fluorinated coating material, bulk mixing, plasticizer-resistant adhesive, anti-adhesive, bioabsorbable material, Current Good Manufacturing Practice, acrylate coating material, cold seal adhesive, medical pressure-sensitive adhesive, Band-Aid, adhesive transmittance, abrasive coating material, ultraviolet-curable pressure-sensitive adhesive, adhesive primer, coating measurement, silicon bonding, printing defect, solventless adhesive, printing quality control, flexible coating material, thermally conductive adhesive material, steel adhesive, surface-mount technology adhesive, conductive adhesive bonding, adhesion science, thermosetting adhesive formulation, four-color printing, coating thickness, paper adhesive, metal adhesive, pressure-sensitive tape, optical adhesive cement, coating equipment, latex paper coating material, flexographic printing plate, composite material manufacturing cost estimation, water-activated adhesive, metal bonding, plastic adhesive, adhesive dispensing equipment, aerospace, high-performance protective coating, radiation-curable adhesive, paper curl, hot-melt fabric bonding adhesive, wood adhesive bond durability, rotary screen printing, batch mixing, fiber-reinforced adhesive, adhesive formulation technology, coating die design, water-based adhesive shelf life, clean room operations, chemical production quality management, chemical manufacturing technology, operating cost, electronic component-to-substrate adhesive bonding, manufacturing profitability, high-temperature coating material, deposition, adhesion, polymer bonding, chemical processing, coating material, kiss-roll coating process, phenolic adhesive, synthetic paper, remoistenable adhesive, printing press, medical device, luminescence, irradiation, holography, heat sealing, gravure printing, fine paper, extrusion coating process, epoxy adhesive, coating, black light, automotive coating material, aerospace engineering, adhesive tape, adhesion theory

Request Expert

Dev Tool:

Request: expert/cgmp-coatings-pharmaceutical-dietary-supplements-adhesives-die-cutting-security-holograms-printing-operations-management-metrics-and-strategy-and-materials
Matched Rewrite Rule: expert/([^/]+)(?:/([0-9]+))?/?$
Matched Rewrite Query: experts=cgmp-coatings-pharmaceutical-dietary-supplements-adhesives-die-cutting-security-holograms-printing-operations-management-metrics-and-strategy-and-materials&page=
Loaded Template: single-experts.php