Expert Details

Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence

Expert ID: 731331 Illinois, USA

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Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the area of pharmaceutical manufacturing and pharmaceutical development, managing large pharmaceutical development programs, technology transfer and bringing new products to the market, managing large pharmaceutical pilot plants and production units, implementing operational excellence programs, new technology evaluation and licensing and managing global outsourcing for large pharmaceutical companies. Expert had the unique experience of very closely interacting with the FDA for nearly ten years. Twice during his career, Expert was deputed in foreign countries (Belgium and India) where he was responsible to upgrade local plants to meet corporate and U.S. cGMP standards.

Expert also has extensive training in Total Quality Management, Six Sigma, modern leadership principles and practices. At Monsanto, Expert was a licensed trainer on Covey's Seven Habits of Highly Effective People and Principle Centered Leadership. As a trainer, Expert offered classes to employees on these fundamental leadership skills.

Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois - Rockford, Illinois - Aurora, Illinois - Naperville, Illinois - Joliet, Illinois - Elgin, Illinois - South Bend, Indiana - Gary, Indiana - Milwaukee, Wisconsin - Madison, Wisconsin

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Education

Year Degree Subject Institution
Year: 1972 Degree: PhD Subject: Chemical Engineering Institution: University of California, Berkeley
Year: 1991 Degree: MBA Subject: Business Institution: Webster University

Work History

Years Employer Title Department Responsibilities
Years: 2005 to 2013 Employer: Undisclosed Title: Executive Director/President Department: Undisclosed Responsibilities: Expert was responsible for managing the day-to-day operation of this non-profit organization which had 13 major universities as core members. Expert interacted with the FDA, NIH and other government agencies and several faculty members and industry scientists to set up a research and education program. • Expert was able to secure a U01 Grant from the FDA for a period of five years and value not to exceed $35 million. This grant has so far resulted in over 30 research projects for faculty at NIPTE institutions. Expert also led the program to develop a unique set of on-line training modules for the training of FDA reviewers. A total of nearly 200 such modules, which are also completely 508 compliant, has been delivered to the FDA and are in currently in use. These training modules are now part of the continuous educational requirement for the FDA personnel and organized major research conferences in collaboration with the FDA and industry.
Years: 1999 to 2004 Employer: Pfizer, Pharmacia & Searle Title: Undisclosed Department: Manufacturing Responsibilities: Expert was responsible for global outsourcing of all API’s (including biologics) and Finished Dosage Forms. Responsibilities included technical support, understanding the complexities of business deals including manufacturing operations, business forecast, strategic planning, product management, intellectual property rights, quality issues, manufacturing rights, technology licensing, product liability issues, finance, taxation, etc., implementing commercial Supply Agreements, maintaining on-going contracts and re-negotiations of on-going contracts on an as needed basis and outsourcing of clinical supplies, establishing agreements for development activities and for in-licensed technologies.
Years: 1990 to 1999 Employer: Undisclosed Title: Director, Process Development Department: Undisclosed Responsibilities: Expert led a group of over 100 employees comprised of scientists, engineers and technicians to develop processes and provide supplies for Phase I to Phase III clinical studies. Overall responsibilities included providing support to team-based process development for the scale up of process technology from the laboratory to the pilot plant, providing clinical supplies (make or buy) from raw materials to released API’s, and Relocation of technology to manufacturing plants and contract manufacturers.
Years: 1989 to 1990 Employer: Undisclosed Title: Leader, Task Force( Searle-India Project) Department: Undisclosed Responsibilities: Expert successfully led a multi-disciplinary Task Force to study and recommend the future of bulk pharmaceutical chemical, pharmaceutical dosage form and agro-chemical manufacturing business in India. The work involved assessing the plants in India for their cGMP and Safety standards compliance and assessing the viability of continuing business in India. It involved difficult and sensitive negotiations with the local Indian management, Searle corporate compliance groups and senior management and developing win-win solutions.
Years: 1988 to 1989 Employer: Searle Title: Undisclosed Department: Manufacturing & Technical Operations Responsibilities: Expert was responsible for transferring the process for making a new drug to Searle’s plant in Belgium to prepare for its European launch. I managed the upgrade and conversion of the plant to meet corporate cGMP and ESH standards in order for Searle to start manufacturing of this new drug.
Years: 1983 to 1987 Employer: Undisclosed Title: Senior Process Engineer Department: Undisclosed Responsibilities:

International Experience

Years Country / Region Summary
Years: 1988 to 1989 Country / Region: Belgium Summary: Expert was responsible for transferring the process for making a new drug to Searle’s plant in Belgium to prepare for its European launch. I managed the upgrade and conversion of the plant to meet corporate cGMP and ESH standards in order for Searle to start manufacturing of this new drug.
Years: 1989 to 1990 Country / Region: India Summary: Expert successfully led a multidisciplinary Task Force to study and recommend the future of bulk pharmaceutical chemical, pharmaceutical dosage form and agrochemical manufacturing business in India. The work involved assessing the plants in India for their cGMP and Safety standards compliance and assessing the viability of continuing business in India. It involved difficult and sensitive negotiations with the local Indian management, Searle corporate compliance groups and senior management and developing win-win solutions.

Career Accomplishments

Associations / Societies
Members of AIChE, ISPE and AAPS.

Fellow of The American Institute of Chemical Engineers
Publications and Patents Summary
Expert has nearly 30 publications, 2 patents and two recent books on Pharmaceutical Operational Excellence

Additional Experience

Expert Witness Experience
Expert is currently working as an expert witness for a well-known New York law firm who is representing a global multinational pharma company on a pharmaceutical manufacturing issue. Expert has also done some consulting with a global consulting company on an outsourcing issue.
Other Relevant Experience
Expert is an expert on Pharmaceutical Manufacturing Excellence or Operational Excellence. Expert, along with Thomas Friedli of University of St, Gallen, Switzerland has edited two books on this topic.

Expert has also authored several journal articles in the area of pharmaceutical economics.

Language Skills

Language Proficiency
Bengali
Hindi

Fields of Expertise

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