Biologics Consulting Group, Inc.
is pleased to make the following announcement:
Debra Barngrover, Ph.D. will be joining Biologics Consulting Group, Inc., as a Senior Consultant (BioPharmaceutical Products) on April 1, 2011.

Debra comes to BCG with over 25 years of experience in the biopharmaceutical industry.  Most recently, she was Vice President, Technology Development, at Genzyme Corporation.  During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, as well as managing the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products (seven commercial).  She has provided managerial leadership to process development, analytical, formulation development, project management, manufacturing, package and label engineering and risk management functions. She has authored/reviewed several CMC BLA submissions and participated in agency meetings and plant inspections.

Most recently, she was responsible for developing a Supply Chain Risk Management program, which monitored the risks and mitigation strategies for the commercial supply chains, many involving Contract Manufacturing Organizations around the world.  Additionally, she has experience in designing packaging and logistics solutions for cold chain products to multiple markets.

Prior to Genzyme, she worked at Elf Biorecherches (Toulouse, France) and Integrated Genetics, where she was responsible for cell culture process development, bioreactor design and development of serum-free medium for animal cell cultures.  Additionally, she has taught courses in mammalian cell culture, supply chain and recombinant protein development for ISPE, ASME and other organizations.

She holds a B.S. from Colorado State University and a Ph.D. degree in Biochemical Nutrition from Cornell University.

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As a Senior Consultant for BioPharmaceutical Products at The Biologics Consulting Group, Debra will utilize her broad technical and project management expertise to assist clients in the following areas:

• Protein, cell therapy and viral vector process development, technology transfer and scale-up;
• Product development planning, program and alliance management;
• Strategic capacity planning, make/buy decisions, CMO selection and management;
• Temperature sensitive distribution strategy development and packaging design;
• Preparing and reviewing CMC sections of regulatory filings;
• Preparing for facility inspections.

View Debra Barngrover's Curriculum Vitae...

Page Updated March 30, 2011