Materials Science Engineering Consultant Specializing in Development, Testing, Certification and Inspection of Composite Materials and Processes for Aircraft Applications.Composite material characterization, optimization, testing and certification.Manufacturing process development and quality control.Surface preparation and structural bonding of composite structures.Flammability testing of aircraft interiors.Advanced composites, adhesives, sealants, and paints for aerospace applications.Carbon and glass epoxy prepreg selection, characterization and application.Composite destructive and nondestructive inspection development: ultrasonic insp...

Biomedical Sciences PhD Consultant specializing in Gene Therapy, Virology, ProteomicsVirologyOncologyDNA repair and recombinationDNA replicationProtein-DNA interactionsProtein-protein interactionsProteomicsQuantitative-Polymerase Chain Reaction, (PCR)Allele specific-PCRAntibody production-generationImmunofluorescenceImmunoblotingCell biologyCancer biologyMolecular biologyYeast geneticsGene therapyRecombinasesSite directed gene modifications.Cloning, protein expression and protein purification.Trained in various techniques routinely used in biochemistry.Ind...

Medical Device Consultant Specializing in Materials, Design, Test Method Development, Product Development, Quality System Regulations, Process Validation, Supplier Qualification, ISO, FDA and REACH Compliance. Medical Device Process Validation Consultant, Supplier Qualification, ISO, FDA and REACH compliance.Product development from concept to market.21CFR820 (cGMP) and ISO13485 QSR.Polymers and materials for medical devices.Vascular and catheter systems.DOEs and process optimization.Process Validation (IQ, OQ, PQ).Medical device design control process.EPA, FDA, REACH and RoHS compliance regulations.Fluoropolymer and lubricious coating com...

Chemical Market Assessment and Strategy Development; Company Assessment, Workshops and Trainings Specific to ChinaChemical industry in China.Merger and acquisitions, target search in the chemical industry, particularly China.Strategy development in the chemical industry in China.Market trends in chemical industry in China.Research and development optimization in chemical industry.Expert Witness ExperienceLegal matter in merger and acquisitions.Legal matter in development of China chemical industry strategy.Undisclosed Company,...

Drug Discovery and Specialty in Small Molecules, Radiopharmaceuticals, Pre and Post IND PharmaceuticalsDeep understanding of pharmaceutical and biotech industries acquired over 33 years.Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.Pre- and post-IND drug development experience, including translational medicine.Technology platform enhancement and innovation (in-house and in-licensed).Significant business development and strategic planning experience.Exten...

Executive Pharmaceutical Research Physician (MD, PhD) Consultant experienced in Clinical Research (Phase 2-4), Regulatory Affairs (inc. filings), Program Strategy Development, Medical Affairs, Advertising and Promotion, Medical Education, Life-Cycle Management and Launch Activities.Review of digital and non-digital Advertising and Promotion materials for existing brands, as well as new product launches, (U.S. and international) press releases, educational materials, sales rep training, OPDP, (Office of Prescription Drug Promotion) regulations.Life-cycle management and new product launch activities, including:Advisory boards, KOL developmen...

Pharmaceutical, Biotech, Diagnostics and Drug Discover, Commercial Development and Medical Device ProfessionalProduct development programs and projects.Analyze markets, align technology solutions with healthcare market needs, develop insights and business strategy for future customer needs.Develop initiatives programs and drive action plans.Defining and executing winning strategies for successful business growth through deployment of strategic directions, risk management and operational excellence techniques.Pharmaceutical, biotech, diagnostic,and drug discovery.CROs, and medical device markets working within matrix team(s) to identify op...

Bioengineering Consultant with Expertise in Parental Products, Vaccine Production, Protein Purification (Recombinant Protein), Scale up - Downstream Processes, CMC, IND and IMPDPharmaceutical drug development, regulatory affairs, and commercial manufacturing of biologics and combination products.Recombinant proteins of different classes, vaccines, plasmids, small molecules, and combination products involving controlled release formulations.Preform scale up of downstream processes.Development and optimization of protein purification in the recombinant protein production.Regulatory requirements for biopharmaceutical development and manufactu...

Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

Ph.D. Organometallic Consultant Experienced Product Development and Intellectual Property for the Hydrofractioning IndustryFormulating and chemistry of hydraulic fracturing stimulation fluids.Organometallic cross-linkers and catalysts.Adhesion promoters.Sol-gel technology.Hydrophobic and oleophobic coatings.Fluorinated surfactants.Development and testing of coating systems.Patent searching and analysis.Root cause analysis.Expert Witness ExperienceProvided expert witness testimony on organosilicon chemistry: Deposition in a patent infringement case.