Biologics Consulting Group, Inc.
is pleased to make the following announcement:
Ronald
A. Marchesani, B.Sc. joined Biologics Consulting Group, Inc.,
as a Senior Consultant in February 2007 and took over as the Head
of West Coast Operations in June 2007.
Ron
received his Bachelor of Chemistry and Biology from the University
of Miami, Coral Gables, Florida in 1975. He has also taken Post
Graduate courses in Preparation of Parenteral Medications from University
of Tennessee in 1981. He has obtained a MBA Certification from Tulane
University, Freeman School of Business in 2003.
Ron
started his career in the radiopharmaceutical industry in Manufacturing
and Quality management at Medi-Physics, a subsidiary of Hoffmann
La Roche. From 1978 to 1998, Ron held various quality managerial
positions with Baxter Travenol, Armour Pharmaceuticals, Genzyme
and ImmuLogic Pharmaceutical Corporation.
In
1998, Ron accepted a position with OraVax (now Acambis) as Senior
Director of Quality Assurance. During the next 3 years, Ron also
assumed responsibility for Regulatory Affairs and Quality Control.
In 2001, Ronwas responsible for start-up and validation of Quality
Systems activities at a newly renovated manufacturing facility for
the manufacture of a new Smallpox vaccine for the U.S. government.
In
2003, Ron joined Shire Biologics (now part of GlaxoSmithKline
plc), a major vaccine company in Laval, Quebec, Canada as Vice President
of Quality. He was also responsible for the Biological Warfare Vaccine
Biodefense contract with Canadian Department of National Defense
(DND). He had managerial responsibility for the company's Pandemic
Influenza contract with Health Canada. In late 2004, Ron led
the Quality Control validation efforts in support of the forthcoming
BLA submission for the company's Flu vaccine.
In
2005, Ron joined Genentech, as their Senior Director for Corporate
GMP Compliance. In this position, Ron was responsible for proactively
identifying compliance issues /risks at the Company, contract manufacturers,
and partners supplying clinical and commercial products to Genentech.
He was also responsible for evaluating the Company's GMP compliance
status in relationship to industry and Regulatory Agency expectations
and assessing the effectiveness of corrective actions in response
to internal and third party audits
Ron
is a respected opinion leader in the field of Quality Systems. He
has been invited as a speaker or facilitator at professional meetings
and his favorite topics include dealing with the different Regulatory
GMP expectations during product development, Biodefense vaccines
and GMP Compliance audits
As a Senior Consultant with Biologics Consulting Group, Inc. and
now as Head of West Coast Operations, Ron will utilize his Quality
Systems and Validation expertise to assist clients in the following
aspects of drug / biologic development and manufacturing:
- Quality
System Assessment/Development
- GMP
oversight of contract services (manufacturing and testing)
- GMP
Training
- SOP
Development
- Inspection
Readiness (Routine/PAI)
- Document
system development/review
View
Mr. Marchesani's Curriculum Vitae...
Page
Updated
October 19, 2009
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