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Biologics Consulting Group, Inc. Eugene B. Johnston, joined the Biologics Consulting Group, Inc. (BCG) July 1, 2007 as the Head, North Carolina Office. Mr.
Johnston has over 30 years of experience in FDA-regulated industries
in Quality Assurance, Quality Control and validation. He was most
recently the Vice President, Quality Assurance and Regulatory Affairs
at Biolex, a biopharmaceutical company involved in the development
and production of therapeutic proteins using the Lemna Expression
System(LEX™) which is based on the aquatic plant, Lemna. Mr.
Johnston was responsible for establishing the Quality Assurance,
Quality Control and Regulatory Affairs functions and Biolex and
established the Quality Systems programs for preclinical and clinical
manufacturing operations. In his role at Biolex, Mr. Johnston worked
with cross-functional teams to establish GMP manufacturing capability
for Biolex' plant based protein manufacturing platform to supply
the needs of several Phase 1 and Phase 2 Clinical trails. He was
also responsible for the regulatory operations which provided the
support for the filing of several clinical trail applications. Mr.
Johnston joined Biolex from Xanthon where he served as Vice President
of Quality Systems. Prior to Biogen, Mr. Johnston was Director, Quality Assurance for Pharmacia's Parenteral Products operations where he was responsible for Quality Control and Quality Assurance for Pharmacia's operation for the manufacture of commercial and clinical LVP and SVP products. His background also includes managerial positions with Becton Dickinson. Mr. Johnston received his B.S. in Biology for the University of Dayton and is an ASQ Certified Quality Engineer and Certified Quality Auditor. At Biologics Consulting Group, Gene will use his experience and knowledge to assist clients in:
View Mr. Johnston's Curriculum Vitae... Page Updated October 19, 2009 |
