• 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

• 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.

• 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

• 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

• 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

• 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

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