WORK EXPERIENCE:

Sr.Scientist Confidential, Columbia.MO. 19 Dec2011 to 18 April 2012

• To design,carry out and perform simple and complex experiments and procedures in accordance with all applicable regulatory (i.e.FDA,DEA etc) requirements as defined by protocol,method and SOPs.
• To perform data analysis first level and peer review of data for accuracy and completeness.
• To conduct studies to determine and deliver results involving the composition , structure, properties, relationship, and all critical parameters of the material contracted for testing.
• To prepare standards and specifications for processes, facilities, products, and tests.
• To conduct training of staff on techniques necessary to perform laboratory assignments.

Analytical Chemist Confidential, Dayton. NJ Dec 2010 to Nov 2011

• Perform complete analysis of pharmaceuticals/consumer product's raw materials , in-process, finished products, process validation and stability samples of J & J co, Avon etc customers and it's raw materials using HPLC, GC, UV Spectrophotometer, FTIR, TLC, KF titration, and wet chemical techniques as per in-house methods or USP or NF monographs.
• Troubleshoot and calibrate analytical instruments.
• Prepare analytical reports and maintain documentation of test results.

Associate scientist Confidential, Plainfield, NJ Dec 1999-Jan 2009

• Actively participate in and assist formulation scientists by analyzing samples at different stages of new developing products and hands-on independent bench work.
• Assist formulation scientists to develop product specifications by evaluating physical/chemical properties of raw material and formulations (viscosity, specific gravity, pH etc.)
• Conduct physical stability evaluations necessary to evaluate candidate formulae..
• Effectively participate in scale up and work with Quality Control to eliminate batching and production problems..
• Assisted scientists to generate validation reports, analytical test data reports, and scientific reports.
• Author various SOPs for Analytical R & D and QC department.
• Attend various seminars to keep abreast of regulatory and scientific enhancements, trends and advancements.

• Develop and perform high throughput, qualitative analyses using various laboratory instruments and conducted interpretations for analytical research and development.
• Perform assigned tasks including analysis of raw materials, in-process materials, final product and stability samples with HPLC, GC, FTIR, UV-Vis, and other instruments according to SOPs.
• Perform various extraction and derivatization sample preparation techniques
• Participate in analytical investigations and write related reports such as deviation and OOS reports.
• Write and review SOPs and review analytical data.
• Troubleshoot, calibrate and maintain QC laboratory equipment.Develop and execute IQ/OQ/PQ protocols for QC instruments.
• Participate in stability studies conducted by Analytical R & D and product development scientists.
• Review and monitor stability data on new and reformulated products.

• Develop and validate analytical methods for infant and baby products such as barrier cream, lotions, diaper rash ointment, bubble bath, baby oil, hair and body shampoo etc. using HPLC, GC, FTIR, UV Spectrophotometer and several wet chemical techniques.
• Develop characterization techniques for impurities and other degradation products to support drug formulation development using HPLC and GC.
• Prepare analytical reports for Sr. Scientists.
• Review laboratory notebooks of lab technicians.

• Perform instrumental (HPLC, GC, UV Spectrophotometer, FTIR, and dissolution apparatus) and wet chemical analyses to test finished product, stability, process validation samples and pharmaceutical active and inactive raw material samples.
• Prepare and standardize volumetric and test solutions as per USP monograph.
• Develop and validate analytical methods relating to the support of marketed products.
• Prepare analytical reports, document and maintain data from testing of raw material, in-process material, final product and stability samples.

• Perform complete analysis of pharmaceutical in-process, finished products, process validation and stability samples of solid dosage forms and raw materials using HPLC, GC, UV Spectrophotometer, FTIR, TLC, KF titration, dissolution apparatus and wet chemical techniques as per in-house methods or USP or NF monographs.
• Troubleshoot and calibrate analytical instruments.
• Prepare analytical reports and maintain documentation of test results.
• Analyze and re-certify analytical reference standards.

• Assume a laboratory role as a process research associate in a multi-disciplinary bulk pharmaceutical manufacturing development group that includes parallel chemistry and chemical engineering (reaction, separation, and other unit operations).
• Support the development of robust, cost effective, scalable processes and transfer to the pilot plant and scale up plant subsequently.
• Design, assemble, and conduct lab scale reactions.
• Provide analytical lab support to the local plant as needed.
• Perform routine laboratory experiments in the areas of distillation, precipitation, solid separation, crystallization and drying. Set up batch and continuous reactions.
• Troubleshoot different stages of batch processing, mixing, drying, granulating, milling, compressing and coating by compelling and coordinating validation and investigation data.
• Conduct and set physical and chemical tests of powder blends and finished products.
• Calibrate laboratory instruments, prepare and update SOPs, review analytical data and participate in product and process troubleshooting.

TECHNICAL SUMMARY:

• Extremely skilled in troubleshooting and maintaining instrumentation including HPLC (UPLC/Empower-2, Alliance/Millenium-32, Shimadzu/Class-VP, HP/Chemstation and PE/Turbochrom), GC (HP 5890 and PE Nelson), Dissolution apparatus ( USP #1, 2 and 3 (Distek, Vankel, HR SR 8), Diffusion cell (Logan Franz Cell), FTIR, UV Spectrophotometer, pH meters, and Karl Fisher Titrator.
• Extensive experience with wet chemistry techniques such as TLC, AA, Karl Fisher, pH etc.
• Proficient in developing advanced analytical methods using reverse phase, ion-pairing and normal phase HPLC as well as GC.
• Possess a thorough knowledge of method validation elements and procedures
• Experienced in the interpretation of LC/ and GC/ mass spectra
• Thorough knowledge of GMP/GLP guidelines

SOFTWARE PROFICIENCIES:
Empower, Millenium, Chemstation, Turbochrome, Varian Star Chromatography, Windows 2000 Office & XP

REFERENCES: Available upon request.