Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

Process Development and Scale-up Consultant with Expertise in Water Purification, Specialty and Commodity Chemicals. Membranes, and Advanced CompositesSummary Product development,and commercialization with specific focus to: Water purification, ion exchange, advanced composites, and specialty-commodity chemicals. formulated products (floor finishes, hard surface cleaners, boiler-cooling tower water treatments, food sanitization). Chemical Engineering scale-up, product and product development, commercialization, and process trouble-shooting. PVDF and PTFE membrane filtration and filters. Use of low energy electrical plasmas to achie...

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...

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);...

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...

Bio-Based Polymers and Polyurethane Elastomers Development ExpertDevelopment of bio-based polymers for industrial applications.Polyurethane product development and characterization.Nano-clay composites development.Adhesion science and characterization.Adhesion of lignocellulosic composites.Molecular diffusion in elastomeric, laminated, and composite materials.Thermal analysis, molecular spectroscopy, and polymer characterization.Technical and business development initiatives developing new products and licensing,, increasing efficiency, solving problems and reducing costsIntellectual property portfolio development - bio-polymer based produ...

Bioprocess Engineering in Technology Transfer, GMP Manufacturing, Scale-Up, FMEA, CAPA for the Pharmaceutical IndustryBioprocess engineering specific to equipment (equipment reliability and maintenance), systems and facilities.Bioprocess validation (aseptic processes, equipment, systems, facilities and cleaning).Technological process scale-up from bench top to pilot and commercial manufacturing.Biological active compounds and nanoparticle based drug delivery systems.cGMP manufacturing of pharmaceutical and biopharmaceutical products.Technology transfer to a Contract Manufacturing Organization (CMO) in Canada and U.S.A.Documentation review...

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...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...