Jitendra Kawadkar

About Jitendra Kawadkar

13 years of experience in formulation development (nutra, herbal and pharma) for oral solid/liquid products, innovation for existing OTC products, early and late phase oral liquid/solid & topical formulation (generic & 505B2)development for regulated markets. Leading the team for projects of phase appropriate studies, formulation development for NCEs, & generic molecules and end to end development of multiple APIs combination formulations for oral drug delivery, suspension, topical formulations and clinical supplies on time. Handled fast track QBD n DOE based developments of multiple APIs combination oral solid complex products where APIs stability/content uniformity/processability were challenge. Look after project proposal writing, communication with clients and coordination with cross-functional teams for timely project delivery. Actively involved in facility and employee safety initiatives taken by organization. Taking care of corrective and preventive actions for safety, quality, deliverable, engagement and compliance (why-why analysis and kaizen). Worked in development of generic and differentiated drug products for regulatory markets i.e. Canada, Europe & US. Formulated Pilot Bio, Scale-up, and Exhibit batches of different dosage forms like tablets, capsules, liquid filled capsules, pellets, powder for oral suspension and liquid oral suspension. Better understanding of Physico-chemical characterization, development of Nano structured lipid carrier, Nano crystals, Microparticles and Liposomes. Followed DOE and QBD based approaches to provide more acceptable shape to formulation. Writing of new projects and communication with IPR for Patents. Conducted research as per defined specifications and in line with all GMP/GLP requirements. Responsible for preparation of technology transfer dossier, product specifications and SOPs. Supported to regulatory in filing of new products, re-registration products and query raised by regulatory agencies.

Experience

1. Manager - India & South East Asia - R & d

   Amway Global Services Inc

   Oct 2024 — Present · Gurugram, IN

   Neutraceutical and Ayush formulation development

Education

• Guru Ghasidas University

  Bachelor of Pharmacy (B. Pharma), Pharmacy

  2000 — 2004

• Delhi University

  Doctor of Philosophy (PhD), Pharmaceutical Sciences

  2008 — 2012

• Guru Ghasidas University

  Master of Pharmacy (M. Pharm), Pharmaceutics

  2005 — 2007