Expert Details

Expert in Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design

Expert ID: 728464 New York, USA

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As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical industry as a whole. He has developed quality systems, master validation plans, SOPs, and backup disaster recovery plans and implemented them with multiple servers, magnetic tape backups, and fall over servers. Expert's expertise spans quality assurance, computer software
design, computer hardware, client/server systems, web based systems, full implementation of systems from start to finish, management of scientists, and project management at the highest level in an organization.

As Manager, Chemical Process R & D, Expert designed, developed, and manufactured APIs at the multi-ton scale under total FDA requirements in the controlled substances area. Expert has been involved in at least 10 successful PAIs.

Expert was the Director of Chemical Process Development at Bristol Myers where he designed, developed and manufactured antibiotics, antiviral, and anticancer agents; some at the 600,000 kg level. Expertise in dynamic nmr utilized to follow chemical reactions.

Expert designed, developed and installed/implemented state-of-the-art computer software in the following areas: Order Entry & Point-of-sale inventory control, accounts payable, accounts receivable, CRM, pharmaceutical marketing and sales systems and specializes in designing, developing and deploying web database applications.

Expert has acted as expert witness in a treble damages patent lawsuit. His testimony was instrumental in settling the suit out of court for a large sum of money.

Expert is presently consulting for a major US pharmaceutical company since 2005 in the following areas: Chemical Process Research and Development, process discovery, process optimization, patent analysis, analyses of drug markets, competitive forces, intermediate sourcing, total market analyses, analyses of manufacturers and competitive capabilities, synthetic routes to target molecules, software design, development and implementation.

Expert may consult nationally and internationally, and is also local to the following cities: Rochester, New York - Syracuse, New York - Utica, New York

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Education

Year Degree Subject Institution
Year: 1969 Degree: Ph.D. Subject: Organic Chemistry Institution: Rensselaer Polytechnic Institute
Year: 1965 Degree: B.S. Subject: Chemistry Institution: Rensselaer Polytechnic Institute

Work History

Years Employer Title Department Responsibilities
Years: 2003 to Present Employer: Undisclosed Title: President & CEO Department: Responsibilities: Consultant pharmaceutical industry in chemical process R & D, pharmaceutical marketing and sales. Expertise in the analyses of every aspect of a particular drug - api, competitive forces, opportunities, patent analyses, synthetic design, and process optimization.
Years: 2000 to 2003 Employer: Johnson Matthey Title: IT Manager Department: Pharmaceutical Materials Division Responsibilities: 21 CFR Part 11 implementation of major document management system both hardware, software, validation, and networking. Supervised 15 scientists on this project.
Years: 1994 to 2003 Employer: Johnson Matthey Title: Manager Chemical Process R & D Department: Pharmaceutical Materials Division Responsibilities: Responsible for design, development of organic chemical processes and manufacture of APIs at the thousand kilo level. The emphasis was on controlled substances and organometallic compounds. Managed and supervised a 15-member department.
Years: 1991 to 1994 Employer: Digital Microsystems Title: President & CEO Department: Responsibilities: President and founder of a full line IT company specializing in computer software, hardware, networking, and custom design of manufacturing software with an accounting base.
Years: 1969 to 1991 Employer: Bristol Myers Pharmaceutical R & D Title: Site Director Department: Chemical Process R & D Responsibilities: Directed 22 scientists - BS/MS/Ph.D levels in the manufacture of all new products - antibiotics, antiviral agents, anticancer agents, tranquilizers, and many other products. Pre-IND, IND and NDA involvement at the highest levels.

Manufactured antibiotics at the several hundred ton level.

Additional Experience

Expert Witness Experience
Expert witness for a composition-of-matter patent issued to himself through a major US pharmaceutical company working closely with Skadden Arps in NYC. His testimony was instrumental in the settlement of this case out of court leading to a high cash settlement. His expertise in analytical chemistry and pharmaceutical organic synthesis and methodology contributed greatly to this success.
Training / Seminars
Expert has presented many seminars over the span of his industrial experience. Expert has also developed a course in general organic chemistry for an educational institution.
Vendor Selection
Expert's current consulting activities with a major US pharmaceutical company include this expertise of sourcing intermediates for API manufacture.
Marketing Experience
Expert has written a state-of-the-art software package integrating in all aspects of the drug industry, organic synthesis, competitive forces, patents, DMFs, Orange Book, and other important databases. His expertise in this area is unrivaled. Expert provides a complete picture spanning all industries for a particular drug either generic or branded.
Other Relevant Experience
Expert possesses computer software development for many industries including retail, manufacturing, aqnd the pharmaceutical industry. Expert is an expert in Mobile App development for smart devices such as phones and tablets. Expert has marketed several commercial software packages such as an ERP package, CRM Package, automotive shop package, general accounting, and pharmaceutical marketing and sales.

Expert pioneered in the use of robotics to chemical process optimization designing one of the first fully computer controlled robot systems on a large lab scale. He also designed and developed a semi-micro robotic system to run up to 18 chemical reactions simultaneously under computer control. This was presented at the 9th International Symposium on Laboratory Robotics in 1990.

Expert has the ability to take any corporate database and design, develop and implement a web application of it using AJAX techniques causing it to operate in near windows desktop speed over the web.

Fields of Expertise

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