Business & Academic Environments- Production & Operational Teams, Building B2B Industrial Companies in Plastics, Life Sciences Industries, and ISO 9001 AuditorSummary  Chief Technologist with the successful execution of production and operational teams in business and academic environments. Developed materials and products for B2B industrial companies, in plastics and life sciences industries. Deploying over 15 years of experience in processing plastics, chemicals, and downstream products including films and medical devices.  Author, composing and presenting, scientific papers, grant applications, Patent Inventor, and patent b...

Leader in Operations Development; Preclinical and Clinical Programs with an Integrated Strategic Approach Based on Combined Industry Experience Oncology Clinical Operations, Science, and Strategy ConsOncology and neuroscience program management, including preclinical and clinical development for novel therapeutics. Extensive work in the biotech and pharmaceutical landscapes including key industry trends, customer relations, and competitive landscape. Data-driven analytics and portfolio insights. Early- and late-stage clinical trial management. Site feasibility and startup procedures. Contract and budget review and negotiations. SO...

Medical Device Risk Management, Quality Systems Management, Supplier Qualification and Quality Assurance: In Vitro Diagnostic Medical Devices (Class II), Biotech Manufacturing Operations, Digital Imaging Equipment, and Interventional Devices (Class III), Bio-based MaterialsMedical device and biomedical industry planning, Integration, and organizational improvements, increasing financial performances for U.S. and European businesses.Aligning technology and business strategy, medical device quality management regulations and requirements into effective and useful management systems.Remedial quality management system compliance.Pre-certifica...

Specialists and expert witness in silicone medical devices and related chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions.Specialists in the characterization and qualification of silicone medical devices.Chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions to FDA, particularly related to silicone medical devices and silicone applied technology.Pre-clinical chemical testing and evaluation.Testing protocol preparation; testing protocols of silicone based medical devices.Mechanical testing for manufacture of implantable silicone devices.Polymer characterization, spe...

Consultant bioengineer expert in biomaterial science, nanotechnology, biosynthesis of polymeric biomaterials for implants and drug delivery.Synthesis of biomaterials and biomineralization, wherein a living organism provides an environment that controls the nucleation and growth of unique mineral phases.Synthesis and characterization of self-assembly of block copolymers.Nanostructured composites and polymeric biomaterials production and analysis.Consulting on artificial implants, drug delivery systems and medical devices