Medical Device, Medical Drug Delivery Design and Development for the Biotechnology and Pharmaceutical IndustriesAccomplished engineer/scientist with over 35 years’ experience in the design and development of drug products, pharmaceutical manufacturing processes and medical devices. Successful track record of progressing products from lab bench to commercialization. .Technical Competencies Drug product development and characterization, Process development and scale up, Project management, Identifying and managing vendors, CROs, CMOs, Tech transfer & trouble-shooting, Authoring CMC regulatory submissions, Development of micro-...

Consultant in Computational Modeling. Drug Design, Proteins, Small Molecules, Genetics, Machine Learning, Artificial Intelligence, Bioinformatics and Biomedicine, Materials Discovery, Robotics & ContrSummary  Drug discovery consulting and research and development in Biomedicine. Providing over ten years in biomolecular computational methods (small molecules and proteins, proteomics, genetics).   Drug Discovery and Biomedicine - Health  High throughput virtual screening and docking. Drug candidate identification. QSAR (Quantitative Structure Activity Relationship) and QSPR (Quantitative Structure Property...

Analysis of Soft Materials Expert Witness Reports and Mechanical Characterization of Soft Matter - Ph.D., Medical Device Expert Experienced researcher with a demonstrated history of project management in academic and industrial settings. Excellent communication and presentation skills in chemistry, materials science, data analysis, and polymers. Measurement of tensile and compressive properties of biomedical polymers and metals. Expert Witness Experience  Aided in characterization and compilation of results for hernia mesh litigation. Prepared data for thesis advisor to serve as expert witness in this litigation.

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...