Expert Details

Expert in Laboratory Management; Quality Assurance/Control

Expert ID: 717458 New Jersey, USA

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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.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Philadelphia, Pennsylvania - Allentown, Pennsylvania - Stamford, Connecticut - Baltimore, Maryland

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Education

Year Degree Subject Institution
Year: 1984 Degree: MBA Subject: Management Institution: Fairleigh Dickinson University
Year: 1976 Degree: PhD Subject: Physical Chemistry Institution: Columbia University
Year: 1972 Degree: BS Subject: Chemistry Institution: York College

Work History

Years Employer Title Department Responsibilities
Years: 2016 to 2018 Employer: Self Employed Title: Independent Consultant Department: Responsibilities: Serve as Independent Consultant to the Pharmaceutical, Nutraceutical, and Personal Care Industries
Years: 2000 to 2016 Employer: GARDEN STATE NUTRITIONALS Title: VP, Scientific Operations Department: Quality Operations Responsibilities: Oversee testing operations for all raw materials, bulk, and finished products.
Years: 1995 to 1999 Employer: REVLON RESEARCH CENTER Title: Sr. Director, Analytical Department: Testing and Site Safety Responsibilities: Responsible for testing operations for all marketed personal care products. Also served as site safety director for the research center, and managed the ISO 9001 process for the research center.
Years: 1991 to 1995 Employer: WARNER-LAMBERT COMPANY Title: Sr. Director Department: Analytical Technology Responsibilities: Responsible for the revalidation of all assay methods for marketed drug products. Also was responsible for the analytical testing program for the NOVON products division.
Years: 1988 to 1991 Employer: ELF ATOCHEM NORTH AMERICA Title: Director Department: Analytical and Information Services Responsibilities: Served as Laboratory Director for all testing operations for Atochem N.A.
Years: 1983 to 1988 Employer: DIAMOND SHAMROCK/HENKEL CORPORATION Title: Manager Department: Polymer Characterization Responsibilities: Managed all laboratory testing and information services for the Process Chemicals Division.

International Experience

Years Country / Region Summary
Years: to Present Country / Region: Switzerland, France, Germany Summary: He has conducted company business in Switzerland, France, and Germany.

Career Accomplishments

Associations / Societies
Expert is a Past-President of both the Analytical Laboratory Managers Association and the American Oil Chemists Society. Expert is also an acting member of ALMA, ACS, ASQC, AOAC, ASTM, and AMA.
Professional Appointments
He is on the Editorial Advisory Board of both Pharmaceutical Formulation & Quality Magazine, and Managing the Modern Laboratory. He was a judge in the R & D 100 Award program.
Awards / Recognition
Expert was the Keynote Speaker at the Juran Quality in R&D Conference, the Conference Board of Canada Quality Conference, and the Dow Corning Technology Conference.
Publications and Patents Summary
He has over 35 peer reviewed publications plus two review articles in the areas of analytical chemistry, technical management, and the quality process.

Additional Experience

Expert Witness Experience
Expert has served as an expert witness and provided testimony in patent infringement hearings. He also serves as an expert witness in areas involving product quality and regulatory compliance.
Training / Seminars
He regularly conducts training and short courses in quality systems management and team dynamics at various technical conferences.
Vendor Selection
Expert has experience locating vendors of laboratory equipment, analytical instrumentation, testing laboratories, and laboratory services.

Language Skills

Language Proficiency
French Can read and write

Fields of Expertise

laboratory, laboratory design, laboratory development, testing laboratory, analysis instrument, laboratory procedure, analysis technique, analytical method validation, analytical test, analytical testing, laboratory management, laboratory equipment, laboratory safety, quality assurance, quality control, laboratory quality assurance, liquid crystal nuclear magnetic resonance, nuclear magnetic resonance spectroscopy, analytical chemistry, total quality management, total quality managment in research and development, size-exclusion chromatography, particle-size measurement, particle-size analysis, particle-size distribution determination, analytical laboratory, ISO 9000 series quality system standard, quality assurance management system, team building, HVAC trouble shooting, internal audit, lab testing equipment, laboratory testing, quality assurance project plan, particle classification, business management, real-time spectroscopic analysis, biodegradation test, quality control instrumentation, American Association for Laboratory Accreditation, laboratory accreditation, Current Good Manufacturing Practice, calibration laboratory, over-the-counter cosmetic, analytical chemistry instrument, chemical instrument, stability testing, laboratory hood, pharmaceutical manufacturing facility auditing, 40 CFR Part 160 FIFRA Final Rule, food testing laboratory, pharmaceutical quality assurance, standard operating procedure, food product quality control, degradable plastic, analytical biochemistry, laboratory information management, Malcolm Baldrige National Quality Award requirement, liquid crystal chemistry, food industry quality control, food industry quality assurance, pharmaceutical quality control, chemical testing laboratory, vendor certification, laboratory information management system, particle characterization, biodegradation, quantitative chemical analysis, qualitative chemical analysis, biodegradable plastic film, magnetic resonance, light diffraction, ultracentrifugation, Food and Drug Administration regulation, biodegradable plastic, over-the-counter drug, light scattering spectroscopy, laboratory computerized analytical instrumentation, Good Laboratory Practice, food quality assurance, electron microscopy, chemical analysis

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