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

Nanda Subbarao, Ph.D. joined Biologics Consulting Group, Inc. as a Senior Consultant in June 2007.

Nanda received an M.S. degree in Chemistry in 1980 and a Ph.D. in Bio-Organic Chemistry in 1985 from the Indian Institute of Technology, Bombay, India for a thesis on the Role of Cholesterol in Biomembranes.

Upon receiving her Ph.D. she moved to UC San Francisco, where she worked with Professor Francis Szoka Jr as a post doctoral research fellow. Her research focused on the synthesis and study of peptides that undergo pH dependent conformational change to trigger interactions with liposomes. During this time, she further developed her skills in peptide synthesis and purification, peptide conformational analysis and liposome techniques.

In 1987, she started her training on lipid-protein interaction and protein conformational analysis with Professor Robert MacDonald at Northwestern University. During this time, she acquired additional experience in lipid and protein/peptide purification and analytical techniques, spectroscopy and liposome techniques. She obtained further training as a post doctoral research associate with Dr. David LeMaster at Northwestern University, at which time she focused on conformational analysis of proteins by 2D-NMR of labeled proteins. She acquired experience in the synthesis and analysis of labeled amino acids, fermentation techniques to incorporate the labeled amino acids into the proteins, and protein purification and analysis.

In 1995, Nanda moved to the Quality Control lab at Organics LaGrange where she was responsible for validation of QC methods. She acted as a liaison between QC and R & D and a chromatography software system manager. She also performed equipment quality assurance and participated in supplier audits.

As Scientist in the Monsanto Company Bioprocess Analytics department in St. Louis MO, starting in 1998, Nanda was responsible for the design and implementation of the worksheet system, and validated spreadsheets for lab raw data. She also contributed on the team to set up cGMP systems for the new Biologics QC Laboratory. When the laboratory became operational, she was appointed as the supervisor of the General Chemistry section, acting as people manager for five analysts. She was responsible for the lab Sample Coordination and ICH Stability studies. As the St. Louis site changed names from Monsanto to Pharmacia to Pfizer due to company mergers, she assumed increasing responsibility.

In 2000, she became responsible for the Biologics Stability program from the Development to Commercial phase. In this role, she led the new cGMP Stability Facility construction and validation teams. She set up the new cGMP compliant systems for the Stability Program. Her role also included management of stability studies in contract facilities and the preparation of CMC Stability sections for Biologics Regulatory submissions from the IND to the Commercial stage.

In 2003, Nanda moved to Sandoz (Novartis) in Dayton, NJ as Stability Manager where she led a group of chemists and sample coordinators/stability administrators for the Research and Commercial Stability Program. She was also responsible for stability storage and testing, sample flow, controlled drug substances and Reference Standards. Some of her key achievements at Sandoz included the improvement of the Stability program cGMP compliance to current standards and the set-up of the sample flow system.

As Senior Manager of Quality Control at Sun Pharmaceutical in 2006, she was responsible for the Method Validation and Testing groups of the twenty person-QC department. Her key achievements included the establishment of cGMP systems and upgrade of the stability program to current industry standards.

Nanda has co-authored numerous scientific publications and frequently speaks at Industry Meetings. As a Senior Consultant with Biologics Consulting Group, Nanda will utilize her expertise in stability and laboratory cGMP systems for both biologics and conventional drugs to assist clients in the following aspects of drug development:

• Set up of cGMP laboratory systems
  
• Implementation of stability programs
  
• Evaluation of analytical methods and method validation.
  

View Dr. Subbarao's Curriculum Vitae...

Page Updated April 13, 2010