Chemical Engineering Engineer

VINYAS AJJAMPURA VIJAYENDRA

Walnut, California, (M) 949-***-**** Email: adgsl5@r.postjobfree.com

Linked In profile: https://www.linkedin.com/in/vinyasav

Summary

A Chemical Engineer with 3 years of profound experience in product and process development along with formulation, Analytical Research Development and regulatory support in the Pharmaceutical industry seeking opportunities in the field of chemistry and engineering.

Professional Experience

R&D Chemist Nov 2017-Present

Research & Development department, K.C Pharmaceuticals Inc., Pomona, California

•Designing and conducting Analytical Method Developments and Validations for Assays as per USP, ICH, USFDA and 21 CFR Part 11 guidelines

•Designing and conducting over 10 cleaning and process validations for new products and manufacturing equipment along with data analysis for process viability

•Successfully carried out reverse engineering and development for 3 products with the R&D team

•Liaised as R&D representative with different departments and managed projects well with cross functional teams

•Executed Pilot batches and evaluated stability for over 10 products in a span of 3 years involving formulation adjustment, manufacture, filtration, and filling

•Performed technical scale up of multiple products to manufacturing scale and developed multiple study protocols, SOP’ and assay validations

•Co-wrote new product Safety data sheet, risk assessment reports/elemental impurities and study protocol summary reports

•Thorough operational knowledge of all the major analytical instruments including HPLC, UHPLC, CAD, UV-Vis, AAS, pH, Viscometer along with Chromeleon 7.0 and predecessors

•Proficient in experimental design and equipment IQ/OQ/PQ along with extensive troubleshooting experience

•Managed project timelines, resource planning and deliverables with constant communication and accommodating client requirements optimally

Research and Development Associate Jul 2016-Sept 2016

Formulation and Analytical Development, Syngene International Pvt Ltd, Bangalore, India

•Performed excipient compatibility studies, dissolution studies, forced degradation of different formulations

•Resolved the problem of flavor excipient affecting the physical appearance and ineffective compatibility by optimizing the concentration through HPLC assays and physical monitoring

Education

•M.S. Chemical and Biochemical Engineering, University of California, Irvine March 2017

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•B.E Chemical Engineering, Visvesvaraya Technological University, Belgaum, India July 2015

Accomplishments

•Developed process and assisted with method development for a challenging matrix of emulsion eye drops for a client

•Analyzed preservative loss within a product and determined the required amount of preservative to sustain accelerated stability and prevented loss during manufacturing

•Resolved a case of the filtration hindrance by overseeing and analyzing the entire process and designing an experiment to determine the root cause

•Lead a team of four members for a project on activated carbon in undergraduate work which was selected as one of the best projects by Karnataka State Council for Science and Technology and was awarded funding by Indian Institute of Chemical Engineers, Bangalore regional Council and KSCST

•Managed the Chemical Engineering Association at DSCE as Vice president and Joint secretary for two terms by successfully pooling resources to achieve operational goals

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