Physicist and Engineer Expert in Cleaning Process Development and Validation, Contamination Control, and Yield ImprovementSummaryManufacturing processes for critical, precision, and industrial cleaning.Specific FocusEvaluate, optimize surface quality of manufactured objects and subassemblies (hard surfaces).Evaluate, downselect and implement process equipment and chemistries.Understanding of solvent, aqueous, and "non-chemical processes."Cleaning process design, cleaning process validation.Cleanroom optimization.Set up product monitoring program.Design analytical test program and assess analytical test results.Develop and test cleaning age...

Healthcare Technology Consultant Specializing in Medical Devices Used in Hospitals37 years of national expertise managing the selection, maintenance and safe and effective use of medical equipment and systems used in hospitals.Medical device failure discovery evaluation in various circumstances; determine patient misuse, clinician errors, and root and secondary causes.Mitigating risks through independent test labs and working with healthcare providers and manufacturers.Through clinical and hospital administrative experience, able to convey a broad technical perspective allowing discussions for patient safety improvements and reducing risks...

Fire Protection Engineer with expertise in Arson Investigation and Domestic and International Building CodesCivil engineering and fire protection engineering.Licensed in both disciplines and have a current NCEES international record that allows for ease of reciprocity to all states and many countries.Engineering standards of care and standards of practice for construction plans and documents.Fire & Life Safety systems such as fire sprinkler systems and fire alarm systems.ICC codes and NFPA codes with extensive knowledge in construction, code interpretation and performance-based design.Forensic fire analysis in some cases.International Fire...

Surface Specialist in Coatings and Corrosion Prevention. Development in Fast-cure, Deck Covering Materials, Single-coat Shipboard Coatings and Waterjetting TechnologyDevelopment and usage of materials including polyurethane, polyurea and polyaspartic coating systems.Development of fire retardant polyurethane foams for use in U.S. Navy bedding and furniture.High performance paints and coatings, including nonskid deck covering materials for Naval Sea Systems Command.Shipboard outfitting and furnishing materials.Fire performance of shipboard materials.

GMP, ISO Quality, Compliance, and Audit Expert for Pharmaceutical and Medical DevicesGMP and ISO matters relating to quality control and quality assurance in the medical device, dietary supplement and pharmaceutical industries.Good Manufacturing Practices (GMP), and ISO Certified Lead Auditor.Document control, training, supplier and quality assurance.Auditing, document control, training, supplier and contract quality assurance.Process validation and contractor managementQuality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. Inject...

Aviation Expert with Pilot Certification and Inspection AuthorizationAviation specialist with over forty-four years holding the highest credentials, as both a Pilot and an Aircraft Mechanic.Licensed pilot with a total of 27,885 flight hours; 21,880 in aircraft transportation and 8,866 as Pilot Command.Flight Engineer (Turbojet B-727).Certified Flight Instructor.Ground Instructor: Advanced and Instruments.Airframe and Power Plant Mechanic.Authorized Air Craft Inspector.Aircraft Dispatcher.Expert Witness Experience,For a major aircraft company, provided analysis of an aircraft accident due to failure to adhere to proper maintenance procedur...

Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...

Electrical and Computer Engineer: Embedded Systems, Computer Architecture, Smart Sensors, Wireless Systems and Low Power and VLSIPatent portfolio analysis and asset valuation for license or acquisition.Patent infringement and claim chart development.Low power technology; IC power management.System on chip (ASIC) development; embedded systems and sensor and control systems.RFID (Radio-Frequency Identification) systems development.Computer and semiconductor architecture; computer arithmetic.Chip design, analog and digital and VLSI.Semiconductor memories: SRAM, ROM, MTP, EEPROM, EPROM, DDR, SD card, embedded flash.Smart sensors; smart power...

New Product and Process Development Consultant with a Particular Specialty in Separation, Purification, and Filtration TechnologiesSeparation, fractionation, and purification technologies.Supercritical fluid technologies developing extraction and reactive systems in the alternative energy, neutraceutical, and semiconductor industries.Membrane separation.Phase equilibrium measurement and modeling at conditions up to high temperatures and pressures.Water filtration and purification.Point -of- use filters (e.g., Brita water filters).Development of CBRN (Chemical Biological Radiological Nuclear) equipment using state-of-the-art technologies.

FDA Regulatory Statistician Experienced in all phases of Clinical Trial Design, Analysis, and BiostatisticsBiostatistics: Regulation of drugs, drug devices and biologics.Clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.Expert regulatory statistician (FDA designation).Areas of application include clinical trial design and analysis, interim analyses, multiple imputation, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity stud...