Shawn Knopp Email & Phone Number

New York, Ny, Us

New York, Ny, Us

United States

Program Manager | Genesis Founding Member | Leading Development, Community Outreach & Investor Relations at SagaHallaAs a Program Manager and Genesis Founding Member of SagaHalla, I lead efforts in shaping the platform's development, driving community outreach, and defining the investor value proposition. SagaHalla is a decentralized cooperative inspired by Norse mythology and powered by blockchain technology, offering a unique framework to empower real-world projects, creators, and strategic investors.I oversee the end-to-end development of the platform, ensuring that both the technical and community aspects align with our mission to ignite the 1551 Renaissance—a new era of cooperative opportunities. My work spans managing cross-functional teams, engaging with a growing community of creators and developers, and building strategic partnerships that align with the cooperative's long-term goals.By blending blockchain innovation with sustainable economic models, I help position SagaHalla as a leading force in decentralized governance, offering robust solutions for cooperative growth, transparency, and investor engagement.

Switzerland

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.

Usa/Dubai

As the Founder and Senior Regulatory Consultant at Procept Partners, I lead the development and execution of comprehensive regulatory strategies and manage high-impact development programs for pharmaceutical and medical device companies. With over 20 years of experience in life sciences, I specialize in regulatory submissions (NDA, BLA, IND), CMC/product development, quality systems, and tech transfers. I have a proven track record in steering therapies from early development through commercialization across a wide range of therapeutic areas, including rare diseases, oncology, ophthalmology, and metabolic disorders.Key responsibilities include:Leading cross-functional teams in regulatory submissions, ensuring compliance with FDA, EU, and global health authority standards.Managing Phase 1-3 CMC and clinical development programs, including technology transfers to CDMOs and regulatory alignment for NDA/BLA submissions.Providing strategic leadership in global regulatory interactions, pre-approval inspection (PAI) readiness, and CAPA planning for complex product portfolios.Overseeing quality system integrations, ensuring compliance with cGMP, GLP, and GCP across pharmaceutical and medical device sectors.Leveraging AI-driven tools and methodologies to optimize regulatory project schedules, streamline submissions, and improve operational efficiency.Consulting on blockchain and AI applications in regulatory compliance, quality systems, and product development processes in highly regulated environments.My work spans both large-scale global companies and emerging startups, where I provide expert guidance on navigating regulatory complexities, ensuring inspection readiness, and achieving commercial success. Notable achievements include leading CMC efforts for metabolic disorder programs, facilitating NDA launch schedules, and directing regulatory transitions for EU MDR compliance.

Indianapolis, Indiana

Provided senior project management oversight for complex regulatory/quality/IT/clinical life science client projects including quality compliance, remediation and system integrations.Developed regulatory strategies and leads ubmissions including IND, IDE, NDA, BLA, PMA, 510k, etc. and their global counterparts including CE Marks.Lead cross functional teams across clinical, non-clinical, device engineering, CMC, quality, etc. in generating, analyzing, summarizing and authoring required content for regulated systems and product submissions.Manages FDA and other global health authority via face-face and all other communication channels.Develops quality assurance systems, SOPs, and plans to ensure companies are compliant and meeting business goals.Evaluates manufacturing facilities, labs, clinical sites,contract research providers, and quality units for compliance with current GXP US and global health authority regulations.Develops and implements training modules on Project Management, Regulatory Submissions and Quality Systems.

Louisville, Kentucky Area

Courses: Pharmaceutics, Pharmaceutical Calculations

Raleigh-Durham, North Carolina Area

CMC Team Development and Stage Gate Review,, Submission Content, NDA and ANDA for orals and topicals dermatology products. Global technical support for marketed products.

Bloomington, Indiana Area

Technical project/account manager for transferred aseptically manufactured products/processes.

Greenville, North Carolina Area

Strategic planning, generic product market research.

Greenville, North Carolina Area

Technical project lead for transferred aseptically manufactured products including development and process validation.

Andover, Massachusetts

Operations lead for transferred biotech products to third parties and internally manufacturing sites including process validation, registration batches, and ongoing technical operations support.

Andover, Massachusetts

Product and process development including process validation for phase 1-3 biotech products, CMC content development and authoring.

Phd, Industrial Pharmacy / Pharmaceutics

Mba

Management Consulting

B.S., Chemical Engineering