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...

Expert in Polymers, Plastics, Materials, Plastics & Adhesives; Solving Challenging Industry Problems Resulting in Sales Exceeding $2 Billion.Summary Ph.D. Chemist, Scientist and Executive in chemical and polymer industries with broad a range of experience including research and development, intellectual property, manufacturing, and business development. Specific focus to polymers, plastics, materials, composites, adhesives, coatings, and failure analysis. Providing over 30 years of industrial experience as a Scientist, R&D Manager, Director of Research and Development, Chief Technology Officer, and Director of Manufacturing with the...

OTD/Occupational Therapy and Psychiatric Industry Writing and Author, including the Legal SectorRegulatory Medical Writing Clinical Medical Writing Editing Quality Control Business Development Expert Witness Experience Writing Experience (Phases 1, 2, 3, and 4): Wrote and edited ICH-compliant documents, including investigator brochures (IBs); Investigational New Drug (IND) applications. Marketing Authorization Application (MAA); informed consent documents (ICF); protocols and amendments. Clinical trial agreements (CTAs); clinical study reports (CSRs). Clinical evaluation reports (CERs); biologics license applications (BLA);...

Chemical Process and Catalyst Technology Evaluation, Licensing, Patent Analysis, Sales and Marketing, Mergers & Acquisitions, Market Studies, & Strategic PlanningCatalyst and Process Technologies ProductionAcetic acid and acetic anhydride.1,4-butanediol, tetrahydrofuran and gamma butyrolactone.n-butanol and isobutanol, n-butyraldehyde, isobutyraldehyde, 2-ethylhexanol.Carbon dioxide and carbon monoxide.Ethylene, ethylene oxide, ethylene glycols, ethylene glycol ethers, ethanolamines, ethyleneamines, ethoxylates, and polyetherpolyols..Formaldehyde and formic acid.Hydrogen and hydrogen peroxide.Maleic anhydride and phthalic anhydride.Methyl...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...

Pharmaceutical exicpients and fine chemical marketing and technical expert.Over 20 years' experience working in specialty chemicals, biotechnology, food and consulting with broad experience in project management, new business development, intellectual property commercialization and licensing, strategic planning, marketing research, business analysis and merger and acquisition. International experience working with French business leaders in the major industrial sectors while living in France. Specific expertise in:Pharmaceutical ExcipientsRare Earth/Gallium MarketsSilicate MarketNew Business/New Venture EvaluationMarket Research & Strate...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Dietary Supplement and Functional Food Consultant Specializing in NPD Innovation and Quality/GMP ComplianceNatural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance. Natural product ingredient assessments, technical review, and scientific approval. Provide marketing content, direction and guidance for new product launch. New product positioning and marketing strategy, product naming and tag line creation. Natural product: Product quality and marketing integrity: IP protection, regulatory complia...