Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Ruth E. Wager, Ph.D. joined the Biologics Consulting Group, Inc. (BCG) as a Senior Consultant on April 1, 2008.

Ruth has over ten years of industry experience in the technical, quality and regulatory requirements of biologic and small molecule product development and commercialization. Her strong, broad scientific education has afforded her varied employment experience, including experience with diagnostic and therapeutic pre-clinical, clinical, and commercial product development. She has expertise in R&D, GLP and cGMP activities from small organizations to multinational pharmaceutical corporations. Her specialties include product and process characterization, analytical test method development, release and stability testing requirements, and investigation resolution.

Ruth’s most recent position was at Amgen where she held the position of Director of Corporate Product Quality, overseeing the quality of Amgen’s products throughout their lifecycle.  She was the point person for quality and scientific guidance regarding quality standards and practices, and resolution of product quality issues, i.e. nonconformances, investigations, complaints, etc.  Responsible for creating and continuously improving corporate quality systems for commercialization operations across sites, she identified and implemented several Corporate Product Quality initiatives and business processes to improve quality standards during development and manufacturing operations. 

Ruth also was a CMC reviewer at the FDA with CBER in the Division of Therapeutic proteins from 2002-2004.  She then moved to CDER where she was a CMC reviewer in the Division of Oncology Drug Products until 2005.  While at the FDA, she also served as a consult reviewer for the Center for Devices and Radiologic Health regarding biologic/device and drug/device combination products.

Prior to her tenure at the FDA, Ruth held several academic positions and worked as a scientist at Human Genome Sciences, Inc. and Bracco Research USA.  These positions allowed Ruth to gain expertise in a variety of analytical methodologies, GLP, and cGMP.

Ruth received her B.A. in Biochemistry from the University of Pennsylvania, and her Ph.D. in Biochemistry and Molecular Biophysics from Columbia University.

As a Senior Consultant with Biologics Consulting Group, Ruth will utilize her broad scientific education and professional experience in drug development and regulatory affairs to assist clients with:

• CMC development planning for biologic and small molecule drugs
• Strategizing, preparation and critical review of all types of CMC-related regulatory documents

• Preparations for FDA meetings
• Investigation design and resolution

View Dr. Wager's Curriculum Vitae...

Page Updated August 21, 2008