Pushkar Kulkarni

**F, Fantasy Ln, Lillington (NC), 27546 910-***-**** ac6jwo@r.postjobfree.com

https://in.linkedin.com/in/pushkar-kulkarni-30446ba4 (Or scan the QR code) Summary

Hands on experience, precise execution, documentation and data analysis expertise of spectroscopic, chromatographic & thermal analytical techniques involving FT-IR, UV-Vis, HPLC, GC, DSC, TGA, MSA. Education

Master of Science May-18 Campbell University (Buies Creek, NC) Major: Pharmaceutical Sciences

GPA: 3.50 - Cum Laude.

Bachelor of pharmacy April 2015 Savitribai Phule Pune University (Pune, India) Major: Pharmacy

Graduated with Academic Honors of ‘First Class’.

Relevant courses: Organic/analytical chemistry, Biochemistry, Pharmaceutics, Pharmacology. Skills & Abilities

Statistical analysis

Working knowledge of Biostatistics, Design of Experiment (DoE), Multivariate analysis (MVA) with proficiency in using JMP statistical program. Ability to perform OOS, OOT analysis. Proficient in Excel, Word & PowerPoint. Laboratory skills

Ability to work efficiently in accordance with GLP, MSDS safety, FDA, and USP guidelines to generate reliable and accurate data.

Regulatory guidelines

Familiarity and knowledge of regulatory guidelines including FDA 21 CFR, ISO, & USP. Ability to perform equipment validation with regards to IQ/OQ/PQ.

Understanding of Quality by Design QbD

Beginner-Intermediate level understanding of the principles of Quality Risk Management (QRM), Failure Mode Effect Analysis (FMEA) using risk priority numbers (RPN), and Quality by Design (QBD). Laboratory Experience

Laboratory Assistant Campbell University Jan 18 – Apr 18 Facilitated in experimental setup of lab equipment like Tablet press, High shear granulator, Lyophilizer, Dissolution apparatus, Franz cell apparatus, Particle size analyzer, pH meter, LOD, microscope, HPLC-UV. Assisted and supervised aseptic sterile gloving & gowning procedure in accordance with ISO requirements. Trained students in the lab with regards to SOPs, GLP, cGMP requirements and assured smooth functioning of the lab.

Teaching Assistant Campbell University Jan 18 – Apr 18 Instructed Doctor of Pharmacy students in the lab with regards to compounding pharmacy principles. 2

Graded Compounding Pharmacy Records and provided feedback with regards to Good Documentation Practices. Demonstrated ability to perform required duties with limited supervision. Research Assistant Campbell University Jan 17 – Dec 17 Assisted in the ongoing project of developing In-vitro release characterization of Brinzolamide ophthalmic suspension with respect to FDA-USP requirements using RP-HPLC. Clinical Information System – Data entry of patients for clinical research in the JMP statistical program. Laboratory Management – Met the Inventory goals of the lab for the academic year by ensuring sufficient reagents and supplies. Performed routine laboratory tasks like performing glass-wash, pH meter, and balance calibration Research Experience

Research Thesis – Formulation & evaluation of Phenytoin orally disintegrating tablets. This project involved formulation and further QC evaluation of phenytoin oral disintegrating tablets manufactured using direct compression and use of superdisintegrants. It involved optimal experimental design for the formulation of tablets. Conducted shelf life and stability studies. A complete analysis of punch-displacement profile in tableting using compaction simulator. This project involves the use of a compaction simulator in evaluating the effect of particle size, compression pressure & dwell time on work of compaction and tensile strength of tablets. Developed theory to analyze and model in-die viscoelastic properties of the granulating agent. Memberships

Parenteral Drug Association (PDA)

Student Member

Southeast student chapter – Campbell University

International Society for Pharmaceutical Engineering (ISPE) Student Member

Campbell University

Poster presentation

8th Annual Interprofessional Health Sciences Research Symposium. Presented research thesis: Formulation & evaluation of Phenytoin orally disintegrating tablets. Awards

Winner of the Scientific model competition

Won award for a scientific model of ‘Low-cost microscope’ at AISSMS college of pharmacy annual convention. Certifications

Six Sigma Foundations

Excel 2016: Advanced Formulas & Functions

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