JB Life Sciences
Expert CMC Problem Solving
The founder of JB Life Sciences is Jay Breaux, Ph. D., R.A.C.  Jay has more than 30 years of experience working with both innovator and contract research organizations.  His primary focus is in the area of Chemistry, Manufacturing and Controls (CMC) project coordination and CMC regulatory affairs.  Before starting JB Life Sciences, Jay worked as a Director of Medicinal Chemistry at King Pharmaceuticals and a Senior Director of Analytical Chemistry at AAI Pharma.  In addition, he has worked at Cato Research, Pharma Directions and Aventis.  Jay also led project teams and functioned as a CMC expert on discovery and development project teams.
 
Jay has authored and reviewed CMC and other sections of regulatory submissions.  He has participated in FDA meetings and authored responses to FDA questions.  Jay currently holds the Regulatory Affairs Certification (RAC) and was re-certified in 2008.
 
CONTACT INFORMATION
Jay Breaux
7708 Amesbury Drive
Chapel Hill, NC  27524
919 408-0787
919 618-3895 (cell)
jbreaux@nc.rr.com
 
 
 
PROFESSIONAL EXPERIENCE
                                                    
Pharmaceutical Development Consultant.  JB Life Sciences (2008-present)
CMC project coordination and CMC regulatory affairs focus.  Authors and reviews CMC sections of regulatory submissions.
 

Senior CMC Scientist. Pharma Directions, Cary, NC (January-November, 2008)
Senior CMC and CMC regulatory affairs scientist.  Managed out-sourced CMC studies.  Authored and reviewed CMC sections of regulatory submissions.
 

Medicinal Chemistry Director.  King Pharmaceuticals, Cary, NC  (2007)                                         

Directed out-sourced CMC studies.  The studies included the development, validation and transfer of analytical methods to support manufacture.  Directed pre-formulation studies for new candidates. Prepared CMC sections of regulatory submissions. 

                                                                                                       

CMC and Integrated Drug Development Scientist.  Cato Research, Durham NC  (2004-2007)

Prepared CMC and other sections of regulatory submissions.  Prepared drug development plans and performed gap analyses of client development plans. Project team CMC expert.

                              

Senior Director, Analytical Chemistry.  AAI Pharma, Chapel Hill, NC  (2001-2003)

Managed analytical chemistry department consisting of method development, validation, and quality control teams.  Responsible for analytical method validation and analytical sections of regulatory submissions.  Facilitated FDA and client audits and prepared audit responses.
 

R&D Project Manager, Aventis Life Sciences, Frankfurt, Germany  (2001)
Project manager responsible for the integration of the Rhone-Poulenc and Hoechst R&D departments following the merger to form Aventis.
 

R&D Research Director,  Rhone-Poulenc Life Sciences  (1998-2000)

Managed product discovery and development projects.  Responsible for the synthetic and analytical chemistry teams.  Responsible for the chemistry sections of regulatory submissions.
 

Research Director, Rhone-Poulenc Life Sciences, Lyon, France  (1995-1998)
Directed new product research and development projects. Managed integrated chemical synthesis, process chemistry and analytical chemistry support teams. 
 

Analytical Chemistry Manager, Rhone-Poulenc  (1993-1995)

Managed the analytical chemistry discovery and development support teams. Managed the preparation of analytical chemistry sections of regulatory submissions.
 

Discovery Research Manager, Rhone-Poulenc  (1990-1993)

Managed the chemical synthesis and analytical chemistry research support teams.  Project manager for new product discovery projects. 
 

Research Manager, Rhone-Poulenc, Lyon, France   (1987-1990)
Managed new product discovery and development projects.
 

Synthesis Chemist, Analytical Chemist,  Research Group Leader.  Monsanto Co., St. Louis, MO  (1976-1986)                                                                                                 

EDUCATION

 

NIH Post-Doctoral Fellow, Medicinal Chemistry, 1975-1976

Northwestern University,  Evanston, IL
 

Ph. D., Organic Chemistry, 1974

Johns Hopkins University, Baltimore, MD
 

BS,  Biochemistry, 1968

Louisiana State University at Baton Rouge
 

CERTIFICATIONS

 
Regulatory Affairs Certification (RAC)  Re-certified in 2008