Research Executive Visakhapatnam, Andhra Pradesh, India
Since February 2015
Development of patent non-infringing, bioequivalent/generic formulations for regulated markets (US) based on QbD approach.
Preparation of Technology transfer reports, Technology transfer protocols, Risk Assessment, process flow documents and other technology transfer related documents.
Preparation of Registration Dossiers (product development report, Biowaiver justification, Comparitive dissolution profiling, stability evaluation report and reference product characterization) for the stable formulations developed based on QbD approach utilizing the concepts of QTPP, CQA’s and FMEA
Conduct material compatibility studies (MOC), pH incremental studies, solubility studies, stopper extractability studies for parenteral dosage forms.
Initiate Trail batch and Stability study of new products under development.
January 2013 --- February 2015
• Preparation of Stability Studies protocol & carry-out stability studies. • Provide updates & information required for registration of drugs. • Documentation of all R&D activities as per GMP and GLP. • Execution of Pilot and Scale-up batches. • Optimization of product composition & process. • Pre-formulation studies including drug excipients, compatibility studies, solubility studies etc. • Ability to handle development of generic / patent /Bioequivalent formulations for regulated & non regulated markets. • Experience in sterile products. • Identify new processes to improve the Project Management functions. • Monitoring the progress of the products from the conception of the molecule until the launch of the product.
Research Trainee, Formulation Development
January 2013 --- December 2013
Customer Service Associate
November 2012 --- December 2012
Skills and Expertise
Create SOPs Analyze dataAseptic processingArchive documentationArchive trial documentation and correspondence.Assist with experimentsDesign studiesDetermine statistical analysis
Master's degree in Pharmaceutics from KLE UNIVERSITY in 2012
B. Pharmacy in Pharmaceutics from Andhra University in 2010
Training and Certification
SSE business solution on Design of Experiments in 2015 Certification