Shawn Knopp

About Shawn Knopp

Experienced pharmaceutical executive and consultant with 20+ years leading- Product development and CMC strategy across solid dose, injectable, and inhaled therapies- Global regulatory submissions (IND, NDA, BLA, MDR) and agency engagement- Quality systems design, inspection readiness, and post-acquisition QMS integration- Cross-functional program management spanning clinical, regulatory, and manufacturing- CDMO/CRO oversight, GMP campaign execution, and tech transfer initiativesI’ve worked with industry leaders like Pfizer, Johnson & Johnson, GSK, and Baxter, as well as breakthrough innovators in gene therapy, rare disease, and digital health.Through my consulting firm, Procept Partners, I lead high-impact development programs across the lifecycle — helping clients integrate strategy, execution, and innovation.I specialize in- Designing inspection-ready QMS frameworks and operational controls- Developing regulatory content and aligning global filing strategies- Leading project delivery using tools like MS Project, Smartsheet, and AI-based forecasting- Implementing AI and blockchain tools for faster decision-making and governance alignment I am passionate about aligning clinical, regulatory, and manufacturing strategies to deliver therapies with speed and precision. I partner with life sciences companies seeking fit-for-purpose systems, efficient execution, and future-ready development platforms. I believe innovation is not only about new science, but how we develop, scale, and sustain it.Let’s connect if you’re building the future of drug development — and want a partner who blends proven leadership with transformational innovation.

Experience

1. Advisor Product, Pharmaceuticals and Medical Devices

   Prasaga Foundation

   Nov 2021 — Present · CH

   Building a world-class ecosystem in the regulated industries of Pharmaceuticals and Medical Devices for Prasaga, the Foundation that has designed the next evolution of blockchain architecture.

Education

• Elon University - Martha and Spencer Love School of Business

  MBA

  2008 — 2010

• Indiana University - Kelley School of Business

  Management Consulting

  2009 — 2010

• Purdue University

  PhD

  1995 — 1999

• University of Louisville

  B.S., Chemical Engineering

  1988 — 1993

Skills

• Process Improvement
• Product Development
• Six Sigma
• Gmp
• Pharmaceutical Industry
• Regulatory Submissions
• V&V
• Technology Transfer
• Validation
• Fda
• Project Portfolio Management
• Quality by Design
• Capa
• Gxp
• Cross-Functional Team Leadership
• Quality System
• Aseptic Processing
• Quality Assurance
• Value Stream Mapping
• Process Excellence
• Sas
• Formulation
• Multivariate Statistics
• Business Process Improvement
• Stage-Gate
• Python
• Linux
• Standard Operating Procedure (Sop)
• Activity Based Management
• R (Statistics)
• C
• V
• Project Management
• Program Management
• Leadership
• Project Planning
• Strategic Planning
• Vendor Management
• Regulatory Affairs