Experienced in Method development, Method validation and verification

An accomplished Analytical scientist with * years of experience in generic

pharmaceutical QC and R&D lab, focusing on analytical services which

include but not limited to Method development, method validation, routine

testing of raw materials, as well as in-process and finished products.

QUALIFICATIONS SUMMARY:

. Experienced in Method development, Method Validation, Method verification

and Method transfer of new analytical methods.

. Performing a Qualitative and Quantitative tests which include analysis of

raw materials, API's, In process and finished pharmaceutical products.

. Stability studies of drug products, maintain stability chart records and

help maintaining in and out flow of stability samples.

. In depth working knowledge of cGMP and R&D, pharmacopoeia and regulatory

requirements for testing and validation procedures.

. Hands on experience in operational knowledge of analytical

instrumentation like HPLC, GC, LC/MS, UPLC, TLC, Dissolution apparatus

(Vankel and Distek), FTIR, UV-VIS spectrophotometer, and KF coulometer,

wet chemistry techniques.

. Maintenance and Calibration of Analytical Instruments such as HPLC, UPLC,

UV, FT-IR, Dissolution apparatus, pH meter and analytical balances.

. Experienced in using chromatography data collection software such as

Empower and Data Interpretation.

. Strong theoretical knowledge in Chromatographic techniques such as Normal

phase and Reversed phase chromatography, Method development and method

validation.

. Documentation of all test results in compliance with Good Manufacturing

Practices (GMP) and Good Laboratory Practices (GLP).

. Basic understanding of USP, FDA regulations and ICH guidelines.

. Familiar with writing SOP's, QSP, QSS and COA's.

. Comfortable working both independently and as part of team.

WORK EXPERIENCE:

May 2011 - Present

Analytical Chemist: Polygen Pharmaceuticals LLC, Edgewood, NY

Responsibilities Include:

. Establishing new analytical methods, Method transfer, Method development

and Analytical Method validation and verification (Assay, Dissolution,

Related compounds and cleaning methods)

. Performing quantitative and qualitative tests including analysis of Raw

materials, API, In-process and Finished products. Perform In-house

standard qualification.

. Preparation of Method validation protocols and reports.

. Complete analysis of raw materials, API's, in process samples and

finished products which include Identification, Specific tests,

Dissolution, Limit tests, Assay, Content uniformity, Blend uniformity,

Related compounds tests, Residual solvents.

. Analyzing samples by various analytical instruments such as HPLC (UV, RI,

PDA detectors), UPLC, GC, TLC, FTIR, Dissolution apparatus (Vankel and

Distek), KF coulometer, UV-VIS and IR spectroscopy.

. Stability studies of drug products at Long Term and Accelerated Storage

Conditions.

. Maintain stability chart records and help maintaining in and out flow of

stability samples.

. Troubleshooting in HPLC and UPLC.

. Maintenance and Calibration of Analytical Instruments which include HPLC,

Dissolution apparatus, weighing balances, pH meter, KF coulometer.

. Handling and testing of controlled substances.

. Experience in using chromatography data collection software such as EM

power and Data Interpretation.

. Documentation of all test results in compliance with Good Manufacturing

Practices (GMP) and Good Laboratory Practices (GLP).

. Familiar with writing QSP, QSS and COA's.

Quality Control Chemist: May 2008 - April 2009, Dr. Reddy's Laboratory,

Hyderabad, India.

. Development of new analytical techniques for analysis of drug products,

and active pharmaceutical ingredients.

. Performed analytical method development and method validation by HPLC for

dissolution, Assay, related compounds.

. Complete analysis of Raw materials, API, Intermediates and Finished

products.

. Hands on experience in handling Agilent & Water's HPLC, Water's UPLC,

LC/MS in quality control testing lab in compliance with cGMP, GLP and ICH

guidelines.

. Performed qualitative and quantitative tests which includes Assay, CU,

Related compounds, Residual solvents, Dissolution testing's, Limit tests,

water content by KF coulometer, ROI, LOD and pH tests.

. Calibration of analytical instruments - HPLC, Dissolution apparatus, FT-

IR, electrical balances, pH meter.

. Maintenance Analytical balances, pH meter, KF.

EDUCATION:

2009-2011

M.S IN ANALYTICAL CHEMISTRY: Governors State University, University Park,

IL, 60484.

. Education Experience: Method development, Chromatography, LC/MS, GC/MS,

Analytical chemistry, Organic & Inorganic chemistry, photochemistry.

Research Assistant: Governors state university, University park, IL

(July 2010-April 2011).

. Prepared and analyzed samples by using HPLC, GC, FT-IR, UV-Visible

spectroscopy, TLC, KF coulometer.

. Gained extensive instrument operating knowledge on LC/MS, and

GC/MS.

. Data Interpretation and collection of chromatography data by using

EM power and ChemStation software's.

. DNA gel electrophoresis, cancer cell study, tissue culture, DNA

binding studies, and florescence studies.

PROJECT: (Governor's State University, University Park, IL.)

'Novel Ruthenium Compounds as Photodynamic Therapeutic Agents'

. Cytotoxicity testing, DNA gel electrophoresis, Cancer cell studies.

. DNA binding studies, Florescence studies, Human tissue culture

preparation.

2004-2008

B.PHARMACY: Osmania University, Hyderabad, India.

Education Experience: Pharmaceutics, Pharmacology, Medicinal Chemistry,

Physical pharmacy, organic & Inorganic chemistry, Analytical Chemistry.

REFERNCES: Available upon request.

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