Edge Therapeutics, a biotechnology company, transforms FDA-approved drugs into therapies that address unmet acute neurological conditions.
A recognized Subject Matter Expert and Certified Process Excellence (Six Sigma) Black Belt professional with over 27 years of experience in the Pharmaceutical, Biotech and Medical Device Industries whose areas of expertise encompasses formulations, process development, technology transfer, commercialization, regulatory filings and inspections, post market life cycle management and product technical support for most pharmaceutical products with specific expertise in Parenteral product dosage forms of solution, solid and semisolid. Parenteral process experience include lyophilization, aseptic dry powder processes, microspheres, liposomes, suspension and other complex drug delivery systems. To date, have completed over 45 projects with no FD483 citation or negative observation from any world regulatory agency. Experience with regulatory filings and site inspections in North America, Europe and South East Asia. Specialties: Expert Witness with regards to Patent Disputes Certified Six Sigma Black Belt (J&J DMAIIC) Terminal Sterilization of proteins and other macromolecules. Controlled Release Pharmaceutical Product Process Development and Scale-up, including suspensions, emulsions and other complex systems. Science Based (Quality by Design) Approach to Product Development, Pharmaceutical and Drug/Device Combination Products.