OBJECTIVE: An enthusiastic, adaptive and fast-learning person with a broad and acute interest in the field of Regulatory affairs, Clinical Research and Quality Assurance. To contribute for a strong background in Research and Development pertaining to Medical Industry, along with unique drive for excellence and success while merging into a globally focused organization that will purposefully utilize my expertise and develop world-class solutions to real world challenges.
- Ability to handle work pressure and meet the deadlines even under minimum supervision.
- Excellent knowledge and experience on HPLC, GC, UV, Dissolution, FT-IR and many other techniques.
- Experience on cell culture techniques, toxicity assays, permeability assays, protein blocking assays, ELISA.
- Experience on Analytical Method Development and Validation.
- Expert in Stability Study planning and testing.
- Good understanding of major EU as well as non-EU regulatory submission.
- Sound Knowledge of Global Regulatory Guidelines.
- Marketing authorisation, Renewals and Variations submission.
- Excellent knowledge on GMP, GLP, SOP, COSHH and ICH guidelines.
- Excellent organization skills, planning, problem solving and good analytical skills.
- Good communication and writing skills, quick learner.
- Computer skills: MS Office, GraphPad, Chemsketch and other internet applications.
October 2013 --- September 2017
PhD Title: Design, development and systematic evaluation of polymer based carrier systems for the oral delivery of insulin.
Supervised By: Dr Anil Vangala Head of Department – Pharmaceutics, Kingston University, London, UK
- Synthesis of a Co-Polymer by conjugating low-molecular-weight chitosan (CS) and mPEG-2000.
- Analysis and Identification of the Co-Polymer by using FT-IR and NMR spectroscopy.
- Formulation of Insulin loaded nanoparticles using Chitosan and PEG-Chitosan polymers via ionotropic gelation technique using Sodium tripolyphosphate as the crosslinker.
- Evaluation of nanoparticle characteristics in terms of particle morphology (using Scanning Electron Microscopy), size, zeta-potential (using Malvern Zetasizer), insulin entrapment/release, and stability
- Development and Validation of analytical methods for the calibration and quantification of insulin using HPLC, LCMS and UV spectroscopy.
- Further In-vitro characterisation of formulations on cells (Caco-2/MDCK), well versed with cell culture technique, toxicity assays, permeability assays, protein blocking, ELISA.
QA Scientist (CK Science)
September 2011 --- April 2013
Routine and non-routine analysis of raw materials, intermediates and finished products (Solids and Liquids) using wide range of analytical techniques like, but not limited to HPLC, GC, Dissolution, FT-IR, UV and wet chemical techniques, coordinating and conducting stability testing, performing analytical method development, Compendial method verification, stability & stress testing, involving in the OOS and OOT investigations, validation of laboratory equipment, data verification and entry on to LIMS, preparation and review of analytical methods, specifications, SOP’s, raw data, stability protocols & reports and deviations or quality incidents all under GMP & GLP standards.
October 2008 --- August 2009
• Preparation of stability protocols & reports, maintenance of stability chambers, non routine analysis and handling (Dissolution, HPLC, UV, IR) • Documentation, planning for stability samples, chemicals and reference standards purchase requisition & ordering and archiving • To carry out work according to GMP and GLP standards
March 2008 --- April 2008
Training in Industrial Environment for 150 hours in various departments eg Production, Quality Control and Quality Assurance (tablets, capsules and liquid orals) with GLP standards
Skills and Expertise
Analytical skills Use a confocal microscopy Write protocolsAnalyze proteinWrite papersWrite statistical reportsValidate dataUse laboratory techniquesUse fluorescence microscopySupervise PhD studentsSolve problemsReview protocolsR&DPublish scientific projectsOral presentationData validationData verificationData entryCell culture
Doctor of Philosophy (PhD) in Pharmaceutical Sciences from Kingston University in 2017
Masters in Pharmaceutical Science with Management Studies from Kingston University in 2011
Bachelors in Pharmacy from Rajiv Gandhi University of Health Sciences in 2008
HSC in Biology, Physics, Chemistry from Kakatiya Jr College, SR Nagar, Hyderabad in 2004
SSC in Class Xth from All Saints High School, Hyderabad in 2002