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Fermentation design and optimization, solid state fermentation, purification operations and production of small and large molecules by biochemical routes.Design of fermenters, fermentation optimization and solid state fermentation.Pilot plant fermenters.Bubble column fermenters.Spray drying of bioproducts; ultra filtration of bioproducts.Fermentation contamination abatement.Solvent extraction of fermentation products and biproducts.Experience with: Enzyme production, organic acid production, amino acid production, omega 3 fatty acid production, yeast fermentation and starch conversion technology.AccomplishmentsDesigned products and fermen...
Seasoned engineer in pharmaceutical, biotechnology and medical devices manufacturing capital projects, processes and facilities compliant with GMP, FDA and ISO requirements.Capital project implementation, in GMP, FDA and ISO environments through design, construction, commissioning, validation of manufacturing facilities, processes, equipment, and multi-tasking.Oversight of project, process, plant, facilities engineering and architecture and engineering contractors.Engineering support to identify, troubleshoot problems and provide a cost effective solution to maintain and increase productivity.Strategic planning leadership for process impro...
Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments.
Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals.
Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...
Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets.
Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric.
Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...
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...
Multi-Disciplined Expert Working in the Health, Energy, Environment, Advanced Material-Coatings Industries covering areas in: Biomaterials and Bone Tissue Engineering, Drug Delivery, BiodegradablesSummary
Materials Science, Technology and Manufacturing Engineer in Research and Development, (R&D) providing over 27 years of experience working in the industry and academia, Included in Stanford University’s List of World’s Top 2% of Scientists, USA
Metallurgy engineering, coatings and corrosion consultancy: Providing graduate level educational in the STEM area, maintaining a high standard of quality and connecting R&D....
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.
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...