Director, Global Quality, Analytical Science and Technology at Bristol-Myers Squibb
Devens, Massachusetts
Bristol-Myers Squibb
Director, Analytical Science and Technology, Biologics Separations and General Methods Lifecycle
Devens, MA
ZymoGenetics
Senior Scientist
October 2008 to January 2011
Amgen
Scientist
September 2004 to September 2008
Bristol-Myers Squibb
Associate Director, Global Quality Analytics
Devens, MA
Bristol-Myers Squibb
Principal Scientist
March 2014 to March 2015
Seattle, WA
Bristol-Myers Squibb
Senior Scientist
January 2011 to March 2014
Leads a team of scientists responsible for the development, troubleshooting and lifecycle management of separations methods and general analytical tests commonly used for release and stability testing of commercial biopharmaceutical products. Specific responsibilities include providing strategic and technical guidance to facilitate achievement of the teams’ deliverables including; methods validation, methods transfer, methods troubleshooting, method performance monitoring and... Leads a team of scientists responsible for the development, troubleshooting and lifecycle management of separations methods and general analytical tests commonly used for release and stability testing of commercial biopharmaceutical products. Specific responsibilities include providing strategic and technical guidance to facilitate achievement of the teams’ deliverables including; methods validation, methods transfer, methods troubleshooting, method performance monitoring and critical reagent strategy support of global QC and manufacturing groups. Additional responsibilities include but are not limited to serving as a method/technical subject matter expert and authoring/reviewing regulatory submissions. As a leader of the Global Quality Analytical Sciences and Technology organization my team and I own the delivery of robust analytical methods, analytical quality standards and overarching analytical CMC strategies to support both licensure and lifecycle management of biopharmaceutical products.
📖 Summary
Director, Analytical Science and Technology, Biologics Separations and General Methods Lifecycle @ Bristol-Myers Squibb Leads a team of scientists responsible for the development, troubleshooting and lifecycle management of separations methods and general analytical tests commonly used for release and stability testing of commercial biopharmaceutical products. Specific responsibilities include providing strategic and technical guidance to facilitate achievement of the teams’ deliverables including; methods validation, methods transfer, methods troubleshooting, method performance monitoring and critical reagent strategy support of global QC and manufacturing groups. Additional responsibilities include but are not limited to serving as a method/technical subject matter expert and authoring/reviewing regulatory submissions. As a leader of the Global Quality Analytical Sciences and Technology organization my team and I own the delivery of robust analytical methods, analytical quality standards and overarching analytical CMC strategies to support both licensure and lifecycle management of biopharmaceutical products. Devens, MASenior Scientist @ ZymoGenetics Bio-Process Development, Analytical, Characterization, Protein Biochemistry. Team lead biologics characterization and analytical. From October 2008 to January 2011 (2 years 4 months) Scientist @ Amgen Process Development, Analytical Sciences. Protein characterization, method development and transfer, global regulatory CMC submissions. From September 2004 to September 2008 (4 years 1 month) Associate Director, Global Quality Analytics @ Bristol-Myers Squibb Strategic Analytical Leadership serving as the owner of the analytical life cycle for approved products within Global Quality Analytics. This organization is focused on creating and matrix managing the analytical technical agenda from late stage development and validation (collaboratively with Analytical Development) through ROW (rest of world) & PAS (pre-approval supplement) filings, technical support for quality control laboratories around the world, assessment of method performance in the QC labs, life cycle management of specifications (methods and acceptance criteria), and responses to health authority questions on commercial products. Devens, MAPrincipal Scientist @ Bristol-Myers Squibb Working within Global Manufacturing Supply, Bioprocess Development as a principal scientist.Management of extended characterization team, analytical mass spectrometry and capillary electrophoresis labs, with matrix roles as analytical leadership for biologics development and commercialization. From March 2014 to March 2015 (1 year 1 month) Seattle, WASenior Scientist @ Bristol-Myers Squibb Bio-Process and Product Development, Characterization Lead Biologics. Authoring CMC regulatory filings, analytical and characterization method development expertise with emphasis on mass spectrometry and biologics separations methods.. From January 2011 to March 2014 (3 years 3 months)
What company does Brent Meier work for?
Brent Meier works for Bristol-Myers Squibb
What is Brent Meier's role at Bristol-Myers Squibb?
Brent Meier is Director, Analytical Science and Technology, Biologics Separations and General Methods Lifecycle
What industry does Brent Meier work in?
Brent Meier works in the Biotechnology industry.
Who are Brent Meier's colleagues?
Brent Meier's colleagues are Jim Kenyon, Zhihua Liu, Louise Mayrosh, Robert W Rack, Gwen Varady, Jill Carroll, Vinnie Garufi, David Léger, Elodie Bronard, and Poirieux Olivier
Extraversion (E), Intuition (N), Thinking (T), Perceiving (P)
2 year(s), 8 month(s)
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