Expert Details

Expert in Fermentation, Product Recovery, Bioprocess Scale-Up, Bioinformatics, Former ISO 9000 Auditor

Expert ID: 717488 Florida, USA

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Expert (pronounced moy-man, ) is a former certified ISO 9000 auditor. Expert advises on productivity and quality assurance improvements, preparations for current Good Manufacturing Practices (cGMP) for FDA compliance. As an expert user of mainframes, minicomputers and microprocessors, he is familiar with the Capability Maturity Model (CMM) of the Software Engineering Institute. He is the person to call for validations of computer systems.

Expert is an expert in the development of pharmaceutical and biotechnology processes. These processes pertain to antibiotics, enzymes, vitamins, amino acids, allergens, steroids, and their recovery. He served six weeks in Kazakstan as an International Exchange Service Corp. (IESC) Volunteer Executive, to analyze the operation of two huge but nearly paralyzed biotechnology companies. He proposed at the Pentagon integrated solutions for company restructuring in line with U.S. defense conversions interest.

His proposed solutions provided focal points for discussions between Kazakstan and United States government departments. For his efforts he received a letter of appreciation from the Honorable Senator Bradley. Expert has also audited pharmaceutical operations in Israel, Scotland, and the United States.

Expert services companies who need to acquire, assess, or rapidly and economically develop process technology or production capabilities. Expert is a biochemical engineer skilled in microbiology, biochemistry, experimental designs, statistical analyses, and statistical process control. Recent projects include crystallization of a paper company by-product, followed by patent application. He was also involved with a cost evaluation related to marketing a new pharmaceutical product.

As a process development specialist and process engineer, he has guided work on over 40 commercial fermentation processes. He has scaled from volumes of 250 ml. shakeflasks to over 30,000 gallon production reactors. He designed a production method for enzyme deactivation using poisonous gas. He designed and installed equipment for spraydrying and fluidized bed drying, enzyme immobilization and agglomeration, as well as equipment for ultra and dia-filtration, chromatography, and lyophilization. Recently he determined for Union Camp Co. the cost of a new process. With limited information he established, via simulations and scale-up optimizations based upon linear programming, the size of required equipment.

Expert has worked as a systems analyst with the online process control of adiabatic petroleum reforming reactors. He has over 20 years of experience using computers in a pharmaceutical and chemical manufacturing environments. He built, maintained, managed, and analyzed large relational databases for petroleum reforming and pharmaceutical manufacturing. He is the author of mainframe and copyright protected personal computer software used by major pharmaceutical companies for process change tracking in antibiotic production. His Quizer (c) and XY-tBase (c) software links product yields with indexed process documentation, provides quality assurance, and provides a method for validated uniform data entry, data retrieval, engineering calculations, profile averaging, and quick plotting for process visualization. This results in rapid process and yield improvements. The Quizer program, when used by Imcera in Terra Haute, Indiana, delivered a 28 percent antibiotic yield improvement within 8 months' time. The HTL, High Teach Linking Method Program (c), operational at the Professional Service Group associated with the New Jersey Labor Department, provides computer illiterates with off line internet job bank data search capabilities. Another version links job seekers with requirements of incoming jobs via pattern recognition of common skills.

As a biochemical engineer, Expert made it possible for E.R. Squibb & Sons to rise from fifth to second place in the semi-synthetic penicillin market. The success was a result of his development of a stable low-cost production immobilized enzyme process, which helped eliminate competitors.

He improved enzyme production. The Marshall division thereby became the most profitable operations of all of Miles' divisions. He expanded its plant capacity by 35% by fermenting in Europe, shipping of sterile bulk liquid concentrate via a three-week ocean transport, followed by product recovery and finishing in the United States. Here he designed and installed production facilities for production of dust-free detergent enzymes and for the production of immobilized glycoisomerase. He developed major process improvements for production of protease, amylase, pectinase, glyocsidase, glucoamylase, glucoisomerase enzymes used in the detergent, baking, brewery, food, animal fodder, and beverage industries. At Merck & Co. Inc. he doubled chephalosporin fermentation capacity within 2.5 years, using microbial, bioengineering, and computer skills, thereby contributing over $100 million to annual profits.

He was involved in day-to-day operations of pharmaceutical, biotechnology, and chemical plant designs. He performed routine equipment sizing, line sizing calculations, and drew process and instrumentation flow diagrams. As director he was responsible for technology transfer, sales presentations, and project executions. He put the name of John Brown on the map of the United States. Since then, Expert has worked as a subcontractor for several engineering companies to assist them in detail design and engineering of Nutrasweet 1/2 (Aspartame), polymer, biopolymer, and genetic engineering plants.

Expert is an accomplished computer programmer, skilled in the use of mainframe, minicomputer and microprocessor (PC) computers. He started out programming in FORTRAN, to solve his operational needs in pharmaceutical manufacturing using IBM mainframe computers under JCL control using MVS. He worked at Engelhard Industries with a GE 4020 on-line process mini-computer. Profits from biotechnology consulting are reinvented in multimedia software development tools to expand data retrieval of records to include retrieval of images based upon image content. Expert is currently studying subjects in chaos theory which involves finding the locations of stable pairs of non-linear dynamic systems. This led him to the study of Smale horseshoes, Cantor sets and Knot Theory, all of which are known to have made contributions to a better understanding of biological phenomena.

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Expert reviewed a tissue culturing process, and advised a pharmaceutical company on cost reduction methods. He determined the cost of a product manufacturing plant. He supervised laboratory research in the production of a cholesterol-binding product from tall oil, and achieved required 90% purity by crystallization. He advised a chemical engineering company in Volvograd, Russia on the design of hemicellulase derivative manufacturing technology.

Expert may consult nationally and internationally, and is also local to the following cities: Tampa, Florida - Saint Petersburg, Florida - Clearwater, Florida - Cape Coral, Florida - Lakeland, Florida - Largo, Florida - Boynton Beach, Florida - Sarasota, Florida

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Education

Year Degree Subject Institution
Year: 1974 Degree: MBA Subject: Finance Institution: Fairleigh Dickinson University
Year: 1964 Degree: Ph.D. Subject: Biochemistry Institution: Cornell University
Year: 1962 Degree: M.Sc. Subject: Chemical Engineering Institution: Technical University, Delft, Holland
Year: 2001 Degree: Subject: Analysis of DNA and Protein Sequences Institution: Rutgers University Audit course
Year: 2002 Degree: Subject: Homology Modeling of 3D Protein Structures Institution: Rutgers University audit course (in process)

Work History

Years Employer Title Department Responsibilities
Years: 1998 to Present Employer: Undisclosed Title: President/Consultant/Multimedia Software Developer Department: Responsibilities: As a consultant he resolves problems for client companies. He researches inprovements in ab-initio 3D protein structure prediction methods.
Years: 1983 to 1997 Employer: Biomatic Associates Title: President/Consultant/Software Developer Department: Responsibilities: As a biotechnology consultant he assisted many clients. Projects ranged from preparing bid packages for fermentor installations to auditing of operation and manufacturing facilities in Israel to
research on bovine growth hormone production. As an engineering company subcontractor he was involved in detailed design of pharmaceutical
facilities for production of biopolymers and artificial sweeteners.
Years: 1980 to 1982 Employer: John Brown Engineering & Constructors Title: Director/Product Developer/Project Engineer Department: Biotechnology Product Development Responsibilities: He started with detailed engineering design of chemical and pharmaceutical facilities. After he provided John Brown with an overview of the biotechnology world he drew the attention of the CEO and was promoted to director. In this function he guided the engineering staff and brought to the company necessary innovations in technology.
Years: 1976 to 1979 Employer: Merck & Co., Inc . Title: Research Fellow Department: Antibiotic Process Development Responsibilities: At Merck & Co., Inc. Expert filled three functions. He supervised operations and staff and renovated a fermentation laboratory. He provided technical service to two mefoxin antibiotic manufacturing plants. He wrote a manufacturing fermentation data retrieval program, maintained the database,
and optimized manufacturing operations based upon analytical results obtained with programs FERMAV and DATRET. His department contributed $100 million/year to Merck's profits.
Years: 1971 to 1976 Employer: Miles Laboratories Title: Manager of Engineering and Process Research Department: Process Development and Process Engineering, Commercial Enzymes Manufacturing Responsibilities: Upon joining Miles Laboratories Expert quickly taught Miles scientists effective use of experimental designs aided by statistical analysis. This resulted in replacing a surface enzyme fermentation process by a much more economical submerged fermentation process. During his stay at Miles he introduced new first-of-its-kind technology, e.g., spray drying following ultrafiltration; prilling of detergent enzymes; partial replacement of
malt by industrial enzymes in beer manufacturing; and, production of immobilized glucose isomerase enzyme.
Years: 1969 to 1970 Employer: Engelhard Industries Inc. Title: IT Systems Analyst Department: Research and Development Responsibilities: Expert assessed the present value of an installed process computer hooked up to a petroleum refining pilot plant. He advised management to extend the use of this computer to incorporate also a catalytic muffler operation project.
Years: 1964 to 1969 Employer: E. R. Squibb & Sons Title: Research Scientist Department: Fermentation Research and Development Pilot Plant Responsibilities: At E.R. Squibb Expert brought chemical and biochemical engineering expertise to a microbiological-oriented process development approach. He introduced experimental design and statistical analysis as a useful R&D tool. He divided his time between pilot plant operations with process scale-up into manufacturing, and programming of a manufacturing data retrieval system which he used for building a dynamic non-linear fermentation model, which he subsequently optimized by his fats "Generalized Separable Programming Methods". Without knowing it he implemented thereby a state variable feedback method which circumvented "the curse of the dimensionality."
Years: 1962 to 1964 Employer: Cornell University Title: Teaching Assistant/ Research Assistant Department: Biochemistry Responsibilities: Expert enjoyed teaching a class of graduate biochemistry students.

Government Experience

Years Agency Role Description
Years: 1995 to 1995 Agency: D.O.D. Role: IESC Volunteer Executive Consultant Description: Just before Expert traveled to Kazakhstan, Department of Defense personnel learned about Expert' travel plans. Expert was then invited to discuss at the Pentagon the interest of the Departments of Defense, State, and Commerce in providing former biological warfare scientists with continued employment opportunities. Upon his return he presented his view of what could and could not be accomplished and how this could be implemented.

International Experience

Years Country / Region Summary
Years: 1994 to 1994 Country / Region: Israel, Scotland Summary: Expert assisted a U.S. company with auditing biotech facilities and their cGMP and ISO 9000 operations.
Years: 1995 to 1995 Country / Region: Kazakhstan Summary: As an International Executive Service Corp volunteer, he assisted two biotech companies in Kazakhstan. His recommendations became the focus point of discussions between the Kazakh and U.S. government agencies.
Years: 1999 to 1999 Country / Region: Russia Summary: As a Citizen Democratic Corp volunteer, Expert assisted Volgograd engineering and construction and several chemical companies with technology improvement.

Career Accomplishments

Associations / Societies
Expert was a member of the International Society a of Pharmaceutical Engineers and is a member of the American Chemical Society.
Professional Appointments
He is a past Chairman of the ACS Microbial and Biochemical Technology Division's membership committee. Additionally, he is an honorary member of the Dutch Birdbanding Society.
Awards / Recognition
Expert served six weeks in Kazakhstan as an International Executive Service Corp (IESC) volunteer. For his service in Kazakhstan Expert received a silver plate from the IESC. He also received a letter from The Honorable Senator Bill Bradley in appreciation of his service in Kazakhstan.

Additional Experience

Vendor Selection
Expert has experience in locating vendors of: chemical, biotechnology, and pharmaceutical equipment; computer software and hardware; and high-technology items, e.g., parallel processors, Global Positioning Systems, and transputers. He has access to the following resources to aid in vendor location: twenty trade journals which he regularly reads, including: Pharmaceutical Engineering, Computer Design, AI Expert, NASA TECH Briefs, Software, Byte, PC Magazine, and Federal Reserve Bank Reviews. He also has access to publications, Rutgers' libraries, personal contacts, and the Internet.
Marketing Experience
Expert participated in many sales presentations as the technical expert. As a result of his efforts Standard Brands selected John Brown Engineers and Constructors, Inc. for a $100,000 first phase project for construction of an alcohol by fermentation project. This was followed by many more bidding projects which resulted in a high percentage success ratio in obtaining biotechnology design and construction project awards.
Other Relevant Experience
As a biochemist and microbiology expert, Expert has a gift to understand and simplify complicated mathematics. He knows to apply this knowledge in design and implementation of economically feasible projects.

Language Skills

Language Proficiency
Dutch Expert is fluent in Dutch.
German Expert is proficient in German.
French Expert is proficient in French.
Russian, Latin, & Greek. He is able to travel, communicate verbally, and get thoughts across in Russian. He studied Latin and Greek for five years, and read Ovid and De Bello Gallico in Latin, and Homer's Odyssae in Greek.

Fields of Expertise

ISO 9000 auditing, biochemical research, biotechnology, bioinformatics, biochemical process development, scale-up, chemical reactor scale-up, pharmaceutical reactor, pilot plant scale-up, chemical-process flow chart, computer integrated manufacturing, manufacturing software, pharmaceutical reactor, pilot plant scale-up, chemical-process flow chart, pharmaceutical research and development, pharmaceutical research, bioengineering, pharmaceutical manufacturing, pharmaceutical engineering, biotechnology process engineering, biotechnology market research, international technology transfer, chemical processing plant design, computer-aided manufacturing, software development tool, pharmaceutical engineering, product recovery, protein structure prediction, international technology transfer, chemical processing plant design, pharmaceutical manufacturer, ISO 9000 implementation for software, ISO 9000-3, pharmaceutical product development, biotechnology scale-up, diafiltration, pharmaceutical quality assurance, ISO 9000 registration system, pilot plant process development, aspartame, competitive analysis, pharmaceutical industry, sterile processing, technology innovation, nonnutritive sweetener, productivity improvement, penicillin manufacturing, chemical plant manufacturing, design for manufacturability, food sweetener, technology transfer, quality assurance, microbiological biomass fuel production, process-engineering distillation, design for testability, quality-by-design, biological industrial wastewater treatment, decantering, data acquisition, curvilinear regression function, enzyme immobilization, chemical reactor application, biodegradation, designing productivity, chemical reactor design, market research, factory integration, liquid-liquid mass transfer, manufacturing control, enzymal food processing, wastewater, fermentation, absorption application, antibiotic synthesis, biopolymer, biochemical engineering, protein food product, pharmaceutical water treatment system validation, ultrafiltration, statistical process control, software engineering, sanitizing, riboflavin, polysaccharide, papain, microbiology, metalloprotein, maltose, liquid-solid filtration, liquid mixing, lipase, lactam, industrial sterilization, immobilized enzyme, heat exchanger, gum, Good Laboratory Practice, industrial fermentation, facility management, ethanol fuel, equilibrium thermodynamics, enzyme wastewater treatment, enzyme production, dehydrogenase, culture maintenance, computer software, chemical process heat exchanger, chemical engineering, bulk pharmaceutical chemical manufacturing, biotechnology modeling, bioreactor, biochemical separation, bacteriology, bacillus, ascorbic acid, applied microbiology, anaerobic microbiological process, allergen

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