Profile

Expert in Quality, Analytical method development and Validation

Experienced (hands on) in HPLC, GC, TLC, Mass Spectrometry, FTIR

Trained in method transfer; interaction with contract laboratories

Worked in Pharmaceutical, Biotechnology, Nutraceutical, Cosmetic Industries

Good communication and people skills

Professional Experience

Gordon Labs Inc. Jan 2016-Apr 2016

Chemist II, Quality Control (Temporary Assignment)

Dimethicone Assay by FT-IR

Quantification of Menthol in Calizime by Gas-Chromatograph

Quantification of ZnO in Calizime by Atomic Absorption Spectroscopy

Quantification of Salicylic acid by HPLC

Agensys Inc. (Astellas) Aug 2015-Oct 2015

Sr.Quality Control Analyst (Temporary Assignment)

Analyzed samples to determine Drug Conjugate Analyte ratio by UHPLC

Tested samples by imaged capillary electrophoresis and analyzed by Chromeleon

Worked on method transfer from Analytical Development to Quality Control

Baxalta (Baxter’s Spin-off) Jul 2014-Jul 2015

Quality Analyst II (Contractor, Hiregenics)

Performed testing of octanoic acid (caprylate anion) by Ion Chromatography

Tested octanoic acid in engineering runs samples from Technical Services

Trained on the enhanced octanoic acid assay based on Baxter Vienna test procedure

Validated Vienna test procedure for performance attributes of specificity, accuracy, precision, linearity and range

Tested Octanoic acid in Process Validation samples

Sunrider, Stason Pharma and Bioscreen Testing Services Apr 2013-Feb 2014

Chemist (temporary assignments in each company)

Determined loss on drying and disintegration on finished product

Determined pH and % Brix on liquid fill; FT_IR for raw materials

Provided support to manufacturing by testing in-process sample

Analyzed volatile compounds by GC-FID

Analyzed sunscreens by Waters HPLC (Empower)

Peptisyntha Inc. (Solvay Inc.) Feb 2012-Dec 2012

Quality Control Chemist

(Peptisyntha Inc. shut down in Dec.2012)

Performed testing of in-process and finished product samples by HPLC

Performed TLC on raw materials/peptides and released them before deadline

Performed IQ, OQ, PQ on waters HPLC using Empower Software

Operated Analytical instruments (HPLC, GC, TOC, FTIR and Polarimeter)

Herbalife Inc. Apr 2010-Dec 2010

Quality Control Chemist (Temporary Assignment)

Analyzed Vitamin C in multivitamin tablets and Protein Drink Mixes using HPLC

Performed physical testing on tablets such as disintegration, hardness, thickness, average tablet weight and percent moisture

Tested finished product (Cosmetics) for viscosity, specific gravity, refractive index

Watson Inc., Jun 2009-Dec 2009

Quality Control Chemist (Temporary Assignment)

Analyzed Parenteral compounds using reverse phase HPLC

Analyzed Vitamin D3 by LC_MS_MS in raw material, finished product

Reviewed batch records and certificate of analysis

Phenomenex Inc. Nov 2006-Dec 2008

Research Scientist, R&D

Evaluated, developed, validated HPLC methods for small molecules

Purified extracted analytes using Solid Phase Extraction (SPE)

Extracted, purified, quantitated carbamates (pesticides) in spiked apple juice

Quantitated Aflatoxins in spiked peanut butter using HPLC_MS_MS

Neutrogena, Johnson & Johnson Company Jul 2005-Sep 2006

Staff Scientist, Quality Control/Assurance

Supervised Scientists technicians and managed work schedule to meet Lab timelines.

Successfully completed a Project Charter; launched a stability program in QA to determine expiration dating for cosmetics and over-the-counter products

Reported the stability results in Annual Drug Product Review to summarize the stability data over a one-year period belonging to different Categories like Acne, Facial Moisturizing Treatment, Sun, Cosmetics, Hair, Body, and Men's Line

Transferred methods from QA Lab to external manufacturers and from R &D to QA

Alza Pharmaceuticals, Johnson & Johnson Company Jun 1996-Jun 2005

Chemist III, Quality Control

Analyzed drug products like Doxil and EVRA

Trained on HPLC, GC, TLC, IR, UV-VIS and Karl Fisher titration

Adhered to safe practices, quality systems, and GMP in QC lab

Trained analysts in Out of Specification (OOS) investigations and Test Methods Interpreted test results and compared to historical data

Authored several reports, analytical test methods and SOPs

Supported process validation, analytical method transfer and documentation

Tested samples per current laboratory protocol, standard operating procedure and test methods

Education

MS Organic Chemistry, San Jose State University, California

BSc Chemistry, Physics, Math, Ravi Shankar University, India

Award

Neutrogena “Amber” Award for determining the root cause of low actives in one of external manufacturer’s product (2005)

Poster Presentation

HPLC method for cold remedy at HPLC 2008 Conference (Baltimore)

Worked 40 hours per week in every company

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