R&D Scientist, Insys Development Company, Inc.
R&D Scientist 2017-Present: Insys Development Company, Inc.
• Research Associate 2015-2017: Insys Therapeutics, Inc.
• Graduate Teaching Assistant at Arizona State University for the unit operations laboratory and course. Successfully mentored undergraduate students to improve performance in the course. Gained exposure on scale-up/technology transfer of manufacturing and optimization processes.
• Graduate Research Assistant at Arizona State University on multiple collaborated/individual tailored research projects. Trained undergraduate students to develop and validate various experimental procedures/protocols, technical setups and also assisted in writing/evaluating NIH (RO1), DTRA and NSF grant applications/proposals.
• Student President of Chemical Engineering at Sri Venkateswara College of Engineering, Anna University, India.
• Reviewer for scientific journals including IJP, Journal of Molecular Biomarkers & Diagnosis.
Experience in developing engineering deliverables including Process Flow Diagrams, P&IDs and system specifications. • Lead tech transfer and scale-up efforts and experience in developing and implementing robust calibration and preventative maintenance plans and qualification protocols. • Experience working with contract manufacturers and overseeing production of clinical batches • Experience in API pre-formulation and formulation conceptualization, not limited to surface area, porosity, particle size distribution, physical and chemical stability of API under stress conditions, pH solubility and pH stability. • Design Expert software for pre-formulation, formulation characterization and optimization. • Stability evaluation as per ICH guidelines and determination of degradation pathways for API’s, potential impurity, excipients. Evaluation of excipients to overcome the instabilities. • Solid state monitoring of API using Differential Scanning Calorimeter (DSC), Thermogravimetric analyzer (TGA), FTIR. • Knowledge and bench scale exposure to pharmaceutical manufacturing process such as blending, granulation, drying and lyophilization techniques. • Knowledge of statistical experimental design & data analysis using JMP. • Experience in working and monitoring with external contract labs and reviewing data and modification of the formulations and dosage forms accordingly. • Writing Chemistry Manufacturing Control (CMC) sections of the Investigational New Drug Application (IND) and New Drug Application (NDA) for submission to the Food and Drug Administration (FDA) for the approval of pharmaceutical products. Instruments: SEM, Beckman Coulter UV-Vis Spectrophotometer, TA XT+ Texture Analyzer, Plasma Cleaner, Laser diffraction particle size analyzer (Nicomp 3000Z and Malvern Nano ZS), ATR-FTIR Spectrometer, ICM vial filling machine, Fann Viscometer, LabRaM Resodyn Acoustic mixer, Ball Mill, High Pressure Homogenizer (Emulsiflex C5), Ellipsometer, Goniometer, Rheometer. Techniques: PVD, CVD, Spin Coating, Plasma Etching, DSC, TGA. Packages: MATLAB-Simulink, Aspen Plus, Minitab, JMP, AutoCAD, SolidWorks and MS Office.