Area of Expertise:
Rajan Ramaswami, PhD
Rajan Ramaswami is a pharmaceutical and biotech product and process development scientist. He has nearly 25 years of experience in managing chemistry, manufacturing, and controls (CMC) operations for drug development and associated analytical method development programs. Rajan has extensive drug product formulation experience, including nanoparticle, liposomal, and lipid-based delivery systems. He has designed process characterization and validation plans and protocols based on QbD/DOE principles. He has reviewed and compiled the content for numerous Module 3 sections for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs). He has guided clients in CMC integrated product development on a range of products including topical, transdermal, intranasal/inhalation, subcutaneous, and intravenous administration dosage forms. His experience includes small molecules including BCS class II and IV, peptides, short-chain oligonucleotides analogs, recombinant proteins, and autologous cell therapy products. Rajan has a Ph.D. in Chemistry from Carnegie-Mellon University, a M.S. in Polymer Science from Carnegie-Mellon University, and a BSc in Chemistry from the University of Madras in India.