Expert Details

Expert in Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions

Expert ID: 733424 Pennsylvania, USA

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Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals.
Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides cGMP support to the FDA and private industry in manufacturing quality of pharmaceuticals, vaccines, biologics and biotechnology drugs.

Quality management of warning Letters and lean system manufacturing

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

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Education

Year Degree Subject Institution
Year: 1980 Degree: PhD Subject: Fermentation Technology / Biochemical Engineering / Chemistry Institution: University of Manchester
Year: 1977 Degree: MS Subject: Fermentation Technology / Chemical Biosynthesis Institution: University of Manchester
Year: 1976 Degree: BS Hons Subject: Chemistry Institution: University of Leicester

Work History

Years Employer Title Department Responsibilities
Years: 1999 to Present Employer: Undisclosed Title: Managing Partner Department: Responsibilities: Development of core expertise areas within company.
Years: 1994 to 2000 Employer: Inflammatics Title: CEO Department: R&D Responsibilities: CEO of startup biotechnology company. Raised finance and directed production of material to cGMP. Planned clinical trials and selected clinical investigators.
Years: 1991 to 1994 Employer: Sterling Winthrop Title: Director Department: Development Responsibilities: Steered production of biotechnology antibodies production and facility operations for clinical trials materials.
Years: 1989 to 1991 Employer: SmithKline Beecham Title: Development / Manufacturing Department: Assistant Director Responsibilities: Directed start up of biomanufacturing plant for biopharmaceuticals . Project Director for facility bioreactors and processes.
Years: 1985 to 1989 Employer: Allelix Inc Title: Scale-up Manager, Pilot Plant Department: Pilot Plant Responsibilities: Oversee all manufacture of materials for product targets and clinical materials from host production systems.
Years: 1979 to 1984 Employer: Wolfson Institute of Biotechnology Title: Pilot Plant Manager Department: Pilot Plant Responsibilities: Development of industrial processes.

Government Experience

Years Agency Role Description
Years: 2011 to 2016 Agency: USA FDA Role: Quality SME consultant Description: Quality systems, warning Letters Consent Decrees
Years: 2000 to 2002 Agency: USA Department of Defense Role: Consultant for bioterrorism programs Description: Development of plans for manufacture of biological vaccines against threats -- example: Anthrax program.

International Experience

Years Country / Region Summary
Years: 1995 to Present Country / Region: Global Summary: Supplier of services in manufacturing and quality.

Career Accomplishments

Associations / Societies
Patents for bioreactors 1987
Patents for cell culture processes 1988/89
Entrepreneur Award 1995 ; best young talent, 1995
Commendation from Dept Defense for Anthrax vaccine production. 2002
Licenses / Certifications
MRSC C.Chem 1988
MRSB C.Biol 2005
Professional Appointments
Visiting guest lecturer in Biochemistry University McMaster Hamilton Ontario (1985-88).
Awards / Recognition
Commendation -- U.S. Department of Defense (2002) for Anthrax vaccine production.
Publications and Patents Summary
Expert has 20-30 paper and articles in the area of biological processes and equipment and manufacturing techniques.
He has published a full-length book on lean manufacturing in the biological field.

Fields of Expertise

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