Scott DiDomenico


Consultant


Global life sciences project and change management leader with expertise in strategy and business portfolio acumen. Demonstrated ability to design, develop, and launch life sciences products and services within the medical devices, combination products, and pharmaceutical clinical trials industries. Additional experience in quality, procurement, and clinical supply chain management. Specific product experience includes fracture care implants and instruments as well as autoinjector and passive needle guard combination products.

CORE COMPETENCIES

  • Design Controls/DMADV Method
  • Risk Management/FMEA/Hazard Analysis
  • Operating Procedures/Work Instructions
  • Regulatory Submissions
  • Technical Writing/Protocols/Reports
  • Project Management
  • Change Management
  • Change Controls/CAPA
  • Quality Systems Gap Analysis
  • 21 CFR Parts 820.30
  • ISO 9000/ISO 13485/ISO 14971
  • Six Sigma Process Excellence
  • 510k Submissions
  • Leadership Development
  • Workshop Facilitation
  • Communication
  • Continuous Improvement
  • Operating Room Procedures

SELECTED ACCOMPLISHMENTS

  • Project Management and Process Development: Led teams to design and develop processes and capabilities within the pharma industry, resulting in standardization and efficiency improvements.
    • Completed CMC responsibilities and led two early development small molecule neuroscience compounds through appropriate stage gates.
    • Improved unblinding processes in clinical trials.
    • Led numerous Continuous Improvement projects, including workshop facilitation and SOP development.
    • Developed and managed a 3-year roadmap for clinical trial negotiation, contracting, pricing, and payments.
    • Developed global capabilities post-Covid to aid in faster drug supply to patients.
  • Pharma/Device Combination Product Design: Designed and launched various combination products, leading to significant sales volumes.
    • Adhered to 21CFR Part 820.30 for combination product design and development.
    • Executed verification and validation procedures, including drop testing and syringe liquid release to ensure proper dosages.
    • Updated risk management activities, including FMEAs and risk management summary reports.
    • Conducted Human Factors testing with healthcare professionals to develop proper usage and handling instructions.
  • Orthopedic Implant and Instrument Design: Designed graphic cases and implants, resulting in high sales revenue for orthopedic implants and instruments.
    • Worked closely with product development engineers and top orthopedic surgeons to define and prototype designs.
    • Managed design, prototyping, and validation processes using CAD software and lean methodologies.
    • Attended surgeries to ensure the safe and effective use of implants and instruments.
    • Developed associated Design History Files and co-developed Technique Guides for surgical use.

PROFESSIONAL EXPERIENCE

  • Johnson & Johnson, Innovative Medicine
    • Associate Director, Country Insights and Deployment Office (Remote) – 1/20 to 8/24
    • Associate Director, Contracts and Centralized Services (Remote) – 1/17 to 12/19
    • Senior Manager, Strategy & Process Improvement (Remote) – 1/14 to 12/16
    • Chemistry Manufacturing & Control Leader (Raritan, NJ) – 1/13 to 12/13
    • Quality Improvement Leader (Springhouse, PA) – 1/12 to 12/12
    • Senior Scientist, Primary Container and Device (Springhouse, PA) – 3/08 to 12/11
  • DeVry University
    • Adjunct Professor (Fort Washington, PA) – 5/07 to 5/09
  • Johnson & Johnson, Depuy Synthes
    • Sr. Product Development Engineer (West Chester, PA) – 1/00 to 2/08
  • Neapco, Inc.
    • Product Development Engineer (Pottstown, PA) – 1/97 to 12/99
  • JG Furniture
    • Product Development Engineer (Quakertown, PA) – 1/94 to 12/96

EDUCATION

  • Master’s in Business Administration, Business, St. Joseph’s University, Philadelphia, PA – 9/97 to 5/03
  • Bachelor of Science, Mechanical Engineering Tech., Temple University, Philadelphia, PA – 8/91 to 1/94
  • Associate of Science, Mechanical Engineering Technology, LCCC, Schnecksville, PA – 8/89 to 5/91

CERTIFICATION

  • Certified Rapid Learning Cycles Program Manager, Rapid Learning Cycles Institute – 12/09
  • Certified Six Sigma Green Belt (CSSGB), American Society of Quality – 12/11 to Present
  • Certified Leader in Flawless Process Execution (FPX), JNJ FPX – 6/13 to Present
  • Certified in Problem Solving and Decision Making (KT), Kepner-Tregoe – 6/14 to Present

TRAINING

  • AutoCAD, Autodesk – 1/94
  • Pro/Engineer CAD, PTC Corporation – 1/00
  • Orthopedic Sales Basic Training, Depuy Synthes – 1/04
  • Cadaver Lab Procedures, Depuy Synthes – 2/04
  • Operating Room Procedures, Depuy Synthes – 3/04
  • Rapid Learning Cycles Program Management, Rapid Learning Cycles Institute – 12/09
  • Six Sigma Yellow Belt, Johnson and Johnson Quality – 12/10
  • Six Sigma Green Belt, Johnson and Johnson Quality – 12/11
  • Six Sigma Black Belt, Johnson and Johnson Quality – 12/14
  • Dale Carnegie Leadership, Johnson and Johnson Innovative Medicine – 8/17
  • Leaders of Tomorrow, Johnson and Johnson – 12/21

AFFILIATIONS

  • Society of Manufacturing Engineers – 8/92 to 1/94

PUBLICATIONS AND PRESENTATIONS

  • Inventor listed on USPO US Patent #7,951,176, Bone Plate – 5/11
  • Inventor listed on USPO US Patent #8,043,297, Aiming Arm for Bone Plates – 10/11
  • Inventor on USPO US Patent #8,753,348, Compressor-Distractor – 6/14
  • Inventor listed on USPO US Patent #10,653,466, Bone Plate – 5/20