Expert Medicinal Chemistry Consultant Specializing in Organic Medicinal Chemistry with experience in synthetic methodology, glycosidic bonds construction, conventional synthetic methods, natural compounds, biological activities, anti-cancer agents, anti-cardiac agentsSynthetic organic chemistry, analysis of various classes of compounds, achieving successful new challenges toward a position as a Medicinal Chemistry Consultant, and Consultant in chemical marketing.Achieved and conceived synthetic methodology for construction of difficult glycosidic bonds unachievable by conventional synthetic methods, present in many natural compounds that...

Life Sciences Compliance Consultant Specializing in Quality, Regulatory and Validation covering Medical Device Development and Preparing or reviewing CE Mark, FDA, Health Canada and International Regulatory Submissions, ISO, cGMP and FDA Quality and Compliance, EU Authorized Representative, Internal and External Auditing.-per consultant's requestRegulatory and CompliancePreparing CE Mark, FDA, Health Canada and international regulatory submissions; technical and design file reviews.Design control, new product development, product classification, quality system design, implementation and maintenance to ISO 9001, ISO 13485 (including CMDCAS...

Mechanical Engineer Medical Device Consultant for Endoscopic, Surgery, Devices, Respiratory Sleep Apnea DevicesMedical DevicesMedical device product and process development.Design and development of respiratory devices.Medical device injury analysis.Medical device product failure analysis.Diagnostic, monitoring, sedative and therapeutic drug delivery devices.Laparoscopic and endoscopic surgical devices.Surgical stapling devices and skin stapling devices.Oxygen concentrators.Oxygen conserving devices.Sleep Apnea therapy devices, (CPAP, BPAP devices).Spirometry, spirometers and flow sensors.Compressed medical gas storage and delivery.Design...

Consultant for Business and Pricing Analysis for Food Production, Aerospace and HealthcarePricing models for home medical equipment (beds, wheelchair, oxygen equipment, CPAP mask, humidifier, Nebulizer) and aerospace (inflight entertainment, Broadband) products in the U.S.Financial analysis and reports for executive decision makers.Competitive analysis, benchmarking, cost and pricing analysis and industry analysis.Supervised marmalade food processing and business improvement.Developed strategic planning.Implemented systems of food; tomatoes, fried beans, popcorn, strawberry, orange, blueberry preserve quality control and assurance.Plant ma...

Food and Dietary Supplement Consultant specializing in Open Innovation NPD, Microencapsulation and HydrocolloidsFood product development and technology.Microencapsulation technology and delivery systems.Hydrocolloid technology.Functional foods and dietary supplements.Confectionery and chewing gum, baking, beverages and sweet goods experience.Technical management and open innovation development.Expert witness (defendant and plaintiff).Lab build-out and lab management experience.Flavor technology.Short-course developer and adjunct professor at Montclair State University and Rutgers University.

Technical professional with solid experience in all phases of analog/digital circuit design.Areas of experience include general instrumentation:BiomedicalIndustrialAviationConsumer electronics designAdditional areas of involvement include various agency approval and certifications (Processes such as: UL, CSA, FM Certification and European CE compliance).Related SkillsHardware: Low/High speed analog, embedded processor systems and instrumentation.Fluent with 8,16 and 32 bit micro controllers, CPLD / FPGA development and SMPS and HV circuit design.Software: Embedded firmware in C and Verilog.EDA Tools: Spice, Orcad, and Pads PCB.Undisclos...

International Fiber Reinforced Composites and Chemical Processing Expert in Marine and Construction IndustriesCommercialize innovative processing technology for composite wind and water turbine blades.Develop and further composites use worldwide.Developing commercial submerged ocean current turbines.Invented, designed and developed fiberglass reinforcing bars for Polymer and Portland cement based concretes.Invented, designed and developed fiberglass bars used in toxic waste sites.Developed precast Polymer and Portland cement based concrete structures used in waste water and industrial facilities.Polymer concrete structures for bank vaults...

Testifying Chemical Engineering Expert and Investigator for Multiple Chemical Exposure and Environmental Cases for EPA, US DOJ, USDOL-OSHA, and Civil and Criminal casesExpert Witness In:Toxic chemical exposure.Explosions and fires.Regulatory agency enforcement.Medical devices.Environmental contamination.Animal farming nuisance.Railroad tank car accidents.Methamphetamine labs.Industrial and consumer products.Chemical burns.Business interruption loss.Chemical patents.Expert witness for the automotive industry covering, seat belts, airbags, infant and child seats.Retained as expert for U. S. Department of Justice, U. S. Environmental Protecti...

Broad Based Health Care Regulatory Consultant: Operational Excellence, IT, Product Portfolio Management, Health Care Product Portfolio Management and Quality System ConsultantOver 16 years in the pharmaceutical, medical device, biotechnology and healthcare industries.Subject matter expert in health care product portfolio management, project management, operational excellence, quality system improvements, system development life cycle (SDLC), computer system validation (CSV) and regulatory compliance in global operations.Assessments of business operations, quality assurance programs, regulatory, compliance, information technology and manufa...

Strategic CMC development and planning of ophthalmic, respiratory, and nasal products. Formulation development of ophthalmic, respiratory, nasal, and dermatological productsStrategic CMC development and planning of ophthalmic, respiratory, and nasal products.Formulation development of ophthalmic, respiratory, nasal, and dermatological products.Manufacturing process development, technology transfer, and scale-up of ophthalmic, respiratory, and nasal products.Extractables and leachables testing planning and execution for ophthalmic, respiratory, and nasal products.CMC regulatory writer: Pharmaceutical development and stability reports; CMC...