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Expert has demonstrated expertise with the design, development, and start-up of laboratory facilities. These facilities have been used for analytical testing, physical characterization, environmental sample conditioning, and drug stability testing. He has specified and implemented purified water systems, sample conditioning rooms, LIMS systems, HVAC and exhaust systems, laboratory furniture and utilities, fume hoods, and environmental monitoring systems.

With 19 years of experience as an analytical chemist in the chemical-pharmaceutical industry, Expert is skilled in both wet chemical methods of analysis as well as the instrumental techniques of NMR, IR, MS, HPLC, GC, and UV and visible spectroscopy. He is proficient with the elemental techniques of C, H, and N analysis; AAS; and ICP spectroscopy. He is also experienced in the areas of physical characterization and surface analysis techniques.

Expert is skilled in the development and optimization of analytical test methods and instrumental techniques. He is experienced with the design of analytical testing protocols, development of method acceptance criteria, and validation of analytical test methods per USP (1225). Expert also has expertise with the transfer of analytical methods to quality control and contract laboratories.

Expert has 17 years of experience as a research and development laboratory manager and director. He is experienced with organizational development issues involving staffing and recruitment, performance appraisal, team building, and the implementation of reward and recognition systems. Expert's MBA degree in management has enabled him to successfully tackle management issues such as laboratory downsizing, re-organization, re-engineering, and the planning and design of capital and operating budgets.

Expert has expertise in the specification and selection of laboratory equipment and instrumentation for testing applications. He is experienced with the certification of vendors and with establishing instrument specifications. He is familiar with designing laboratory safety programs, purchasing safety-related equipment, and conducting laboratory safety training.

Experienced with quality control operations, Expert has been involved with both raw materials testing and finished product release. He has designed quality assurance systems for several laboratory organizations which included the preparation of QA manuals, development of standard operating procedures, qualification of laboratory equipment, and validation of laboratory facilities and systems. He is thoroughly familiar with GLP and CGMP requirements.

Originally trained in NMR spectroscopy as part of his PhD program, Expert has gained expertise with NMR spectrometers, high-field systems, and NMR instrument vendors. Expert pioneered the field of liquid crystal NMR spectroscopy. He has written review articles and made presentations on NMR spectroscopy as a research tool.

Expert has over 24 years experience managing analytical testing laboratories. He is skilled in laboratory design and start-up, and in the reengineering/restructuring of laboratory operations.

Expert is a recognized expert in developing and implementing total quality management practices within a research and development environment. He has designed TQM courses and trained over 1,000 scientists in quality procedures. He is skilled in starting-up and troubleshooting quality systems within R & D laboratories. Expert is also thoroughly familiar with ISO 9000 registration.

Expert is skilled in determining the molecular weight of water soluble polymers using size-exclusion chromatography. The systems characterized included vinyl pyrrolidone polymers, naphthalene sulfonates, polyacrylates, starches, and polysaccharides.

Expert has experience with characterizing particles by automated sizing techniques including light scattering, light diffraction, light blockage, sedimentation, sieving, ultracentrification, electron microscopy, and electro-zone sensing.

Expert has managed analytical laboratory operations for over twenty years. He is skilled in virtually all areas of analytical laboratory management, including laboratory design, staffing & organization, planning & budgeting, selection of instrumentation & equipment, testing & methods development, and data management. His expertise in this area led to him being selected to serve as President of the Analytical Laboratory Managers Organization in 1995.

He has served as Management Representative in implementing an ISO 9001 Quality System within an R&D organization. He drafted quality manuals and procedures, led internal audit teams, and designed and presented ISO 9000 training courses to both management and laboratory staff.

Expert designed quality assurance management systems in compliance with cGMP requirements which includes preparation of standard operating procedures, developing and executing IQ/OQ/PQ protocol, validation analytical test methods, implementing calibration/metrology systems, conducting internal audits, conducting cGMP training, and performing laboratory failure investigations.

He has developed and presented training courses in the areas of teamwork and team dynamics which he have presented to organizations as well at technical conferences.
He is thoroughly familiar with the teamwork process, and have served as both a trainer and facilitator toward improving the performance of work teams.

Reengineer and restructure/reorganize laboratories.Perform laboratory/facility audits in accordance with ISO/cGMP requirements.Provide training courses in laboratory analysis and quality.Assist in laboratory renovation or modification.Perform laboratory failure investigations and assist in problem solving.