Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with over 33 years of extensive experience in package engineering. Experience working with high profile pharmaceutical and medical device manufacturers. Background in biologics, drug vials (glass and plastic), stoppers, seals, closures, catheters, cardiovascular and imaging products with various tubing sets (both pyrogenic and non-pyrogenic), electro-mechanical devices with various leads, sutures, absorbable implants, endoscopic instruments, cable driven instruments, orthopedic implants and instruments, specimen collection vessels and bags, surgical kits, absorbable dressing and anti-adhesion products, orthopedic implants, and instrument trays.

CORE COMPETENCIES

  • Project Management/Project Leadership
  • Research & Development/Package Engineering
  • Primary/Secondary/Tertiary Packaging
  • Controlled Temperature Shipping Systems
  • Packaging/Component Specifications
  • Thermoforming/Injection Molding
  • Extrusion Blow Molding/Blister Form
  • Vertical/Horizontal Form/Fill/Seal
  • Packaging Printing/Coatings/Sealing
  • ISTA/ASTM/ISO Test Methods and Standards
  • Test Method Validation/V&V Activities
  • Foam Materials/Fabrication
  • Sterilization/Aseptic Filling
  • Labeling/Graphics Design
  • 21 CFR Part 210 Part 211/Part 820
  • Six Sigma/Process Improvement/Lean Thinking

SELECTED ACCOMPLISHMENTS

  • Led development and validation of full-knee, uni-knee, hip and drug coated orthopedic implants, including low oxygen environment packaging, new carton supply sourcing project, orthopedic loaner kit design consulting and testing, packaging conversion-flexible to rigid development and validation, aging studies, sealing process development, procedures-global and site specific creation, sourcing (materials and services-testing, contract packaging, etc.), and root cause assessment for vial damage.
  • Led and executed 6 new product packaging development and validations, covering 140 SKUs, and 12 new product packaging development and validations, covering 1500 SKUs, including packaging conversion-flexible to rigid development and validation, aging studies, sealing process development, procedures, package redesign-size reduction, sourcing (materials and services), test equipment (I.D, acquisition, installation, validation, and procedures), and audit support.
  • Led fragility assessments, ISTA testing, cold chain package design and verification for biologic, 2-sealing process development and transfer, aging studies, USP moisture testing, induction seal equipment-materials-process, packaging operations assessment and production balancing, tooling designs and modifications, labeling process and systems assessment, postponement strategy (inventory and WIP reductions), procedure development, design control compliance and pilot, quick turn material shortage strategy and validation plan, development of return products assessment and salvage methodology, and mentoring Jr. engineers.
  • Completed feasibility phase for packaging on refresh project for $500MM segment of business with project objectives focused at design and cost improvements, including the following:
    • Established short and long term strategies.
    • Led packaging Sub-Team.
    • Developed new market unit design options and led selection process including total cost analysis identifying $500k-1MM in annual savings opportunities.
    • Integral to new labeling design and approach.
    • Key member of process sub-team team in establishing new packaging and manufacturing processes.
    • Key contributor to development and piloting of packaging elements for new design control process.
  • Managed new product packaging and technologies and existing product packaging design, development, and validation, including the following:
    • Implemented fragility and high-speed video analysis.
    • Implemented due diligence and design review processes.
    • Redesigned six existing packages due to recalls and/or customer complaints.
    • Participated in twelve new product launches.
    • Developed packaging design and processes as vehicle to facilitate antimicrobial agent deposition onto sutures.
    • Oversaw development, validation, and implementation of internally developed, global automated graphics creation, management, and printing system.
    • Reviewed custom kit assembler agreements.
    • Organized and co-led 2004 J&J World Wide Packaging Conference & PACE Awards.
    • Created and co-led J&J Cross Franchise Cold Chain Committee and conferences.
  • Led development and implementation of digital printing processes for folding cartons (second phase of digital print strategy) with savings opportunity of over $2MM annually, including the following:
  • Developed components and processes, thermoforms, form/fill/seal, sealing, printing, foams/cushioning, cartons, corrugated, labels, films, foils, Tyvek, seal coatings, sterilization, injection molding, and prototyping.
  • Led development, deployment, and administration of resources in partnership with multidisciplinary R&D teams for new product launches with over approximately 20 new products per year.
  • Mentored 2 engineers to management positions and 2 to sales positions.
  • Ensured compliance with regulations, such as ISO, QSRs, and MDD.
  • Supported sourcing consolidations and commensurate savings opportunities via use of new technologies, strategic partnerships, EOQ leveraging, and reverse auctions.
  • Supported licensing due diligence and integration.
  • 2001 member R&D tax credit team recapturing $13MM+ in missed credits.
  • Led J&J Signature of Quality (SOQ) Team responsible for critical support processes.
  • Integrated packaging development into R&D processes including Design Control.
  • Led packaging portion of design control revamp.
  • Developed packaging development procedures to support healthcare compliance and European supply chain management.
  • Led development, deployment, and administration of graphics resources to meet company objectives in alignment with regulations (ISO, QSRs, and MDD) and country specific national laws, including the following:
    • Served as operations strategy team member for development of 5-year plan/strategy.
    • Advised on framing of current Packaging organizational structure.
    • Determined how to meet and implement MDD requirements into product labeling.
    • Developed graphics systems, processes, and procedures where none existed (zero audit observations on first internal and ISO audits).
    • Implemented first multilingual packaging (7 languages) and coordinated associated activities with overseas affiliates (Marketing, Regulatory, and Distribution).
  • Managed concept, feasibility, design, development, and validation of packaging for sterile disposables, electronics and industrial accessories for new product launches (skin staplers, laser systems, harmonic scalpels, breast biopsy systems stands and cases, etc.), including the following:
    • Led Endoscopic Kit team (multidisciplinary, multi-site team business).
      • Grew business year on year from $15MM to $108MM in two years.
      • Developed new kit system, still unique to industry today.
      • Developed bulk packaging and requirements for custom kit assemblers.
    • Led medical packaging council technical and sourcing groups working on standardization of requirements and components supply supporting $100MM in corporate savings initiatives.
  • Led transfer of packaging operations from Somerville, New Jersey to Cincinnati, OH for equipment, tooling development and validations, on both manual and form/fill/seal processes, including the following:
    • Created and supported documentation, such as specifications, drawings, BOMs, procedures, and work instructions.
    • Conducted pre-release batch discrepancy reconciliation.
    • Installed and validated printing systems, such as lids stock, and labeling including implementation of bar coding.
  • Designed and developed sterile packaging for new products and served as technical support for existing product lines, including the following.
    • Resolved sealing issues at border operation in Mexico and lyophilization issues stemming from poorly formed tubing vials at suppliers.
    • Implemented packaging unitization analysis software.
    • Realized $700k in carton savings based on cost savings projects.
  • Assumed cradle to grave responsibilities for assigned product lines ranging from OTC to ethical/proprietary and generic pharmaceuticals for solid, liquid cream and ointment, and parenteral dosage forms.

PROFESSIONAL EXPERIENCE

  • Focus Packaging Solutions, LLC., Consultant, ( Doylestown, PA) – 2007 to Present
  • (Clients Supported: Zimmer (Multiple Divisions), Medrad, Pipeline Orthopedics & Biotechnology, BMS-Convatec, Pioneer Surgical, Covidien-Tyco Healthcare, Biomimetic, West Pharmaceutical Services, Hollowick, Argon Medical, Smith&Nephew, Hologic, Cirtec, Cambridge Endoscopic Devices, Apollo Endosurgery, Covidien Pharmaceuticals, Aprecia Pharmaceuticals, Brystol Meyers Squibb)
  • Ethicon Inc., Mgr/Principal Engr./Advanced Pkg. Dev. & Pkg Tech Svs. (Somerville, NJ) – 2003 to 2007
  • Ethicon Endo-Surgery, Inc., Manager, R&D Packaging (Cincinnati, Ohio) – 1995 to 2003
  • Ethicon Endo-Surgery, Inc., Section Manager Graphics (Cincinnati, Ohio) – 1994 to 1995
  • Ethicon Endo-Surgery, Inc., Staff Package Engineer, R&D (Cincinnati, Ohio) – 1991 to1994
  • Ethicon, Inc., Sr. Package Engineer, Operations (Cincinnati, Ohio) – 1990 to 1991
  • J&J Patient Care, Inc., Sr. Engineer/Staff Engineer (New Brunswick, NJ) – 1988 to 1990
  • Smith Kline Beckman, Sr. Packaging Engineer (Philadelphia, PA) – 1986 to 1988
  • International Paper Company, Can Shield Division, Sr. Package Engr. (Langhorne, PA) – 1983 to 1986
  • American Cyanamid, Lederle Labs, Pkg. Dev./Supply Supv./Line Supv. (Pearl River, NY) – 1980 to 1983

EDUCATION

  • Bachelor of Science, Packaging, Michigan State University, East Lansing, MI – 1980

CERTIFICATION

  • Process Excellence, Six Sigma Green Belt – 2002

PUBLICATIONS AND PRESENTATIONS AND PATENTS AND AWARDS

  • July Issue of Food & Drug Packaging (Cover) – 2004
  • November issue of Packaging Digest – 2004
  • Speaker-Health Pack 2001 on Six Sigma for Packaging – 2001
  • Medical Device and Diagnostic magazine – Ethicon Endo-Surgery Medical Packager of the Year – 1998
  • U.S. & International Patents on “Locking Holder for Pair of Syringes and Method of Use”, Johnson & Johnson Medical, Inc. (formerly Patient Care) – 1992
  • U.S. & International Patents on “Two Component Syringe Delivery System”, Johnson & Johnson, Medical, Inc. (formerly Patient Care) – 1990
  • IOPP Ameristar & Worldstar Awards for Thermoform Package Design – 2004
  • J&J Standards of Leadership Award for Management Support – 2004
  • J&J Standards of Leadership Award for Project Boxster – 2002
  • Recognition for R&D Tax Credit and J&J Signature of Quality initiatives – 2000
  • Ethicon Endo-Surgery, Inc.- Operations ‘Taking the Lead’ Peer Recognition Award for Packaging – 2000
  • Ethicon Endo-Surgery, Inc. – Presidents Quality Award for the COGS Review Process – 1998
  • Ethicon, Inc. Awards for Linear Cutter, Circular Stapler, Clip-Applier and Form/Fill/ Seal Projects – 1991
  • SmithKline & Beckman, Inc. – Vice President Impact Award for Pre-Natal Vitamin Print Prod. – 1987