Kamlesh Patel aczpuu@r.postjobfree.com

** ****** **, **********, **-01453 978-***-****

Summary:

Pharmaceutical/ Biopharmaceutical QC professional with extensive years of hands on experience performing raw material compendia and non-compendia Identification test.

Performed various Wet chemistry assay and FTIR, KF, Refractometer, Melting point etc and conduct a variety of analytical lab tests in compliance with standard testing methods, procedures and regulations; implement quality control specifications.

Experience testing finish product and stability study samples.

Experience in Reversed Phase-HPLC, Ion Exchange-HPLC, Size Exclusion-HPLC.

Performed SDS-PAGE electrophoresis analysis of protein and peptide

Experience in Synthetic Organic Chemistry.

Experienced in analytical instrumentations along with characterization, calibration & maintenance of instruments.

Experience operating variety of treatment test equipment, such as HPLC, Spectrometry, pH meter, filtration devices, Melting Point, balances, etc.

Skills:

Instrument Calibration

Performed Analytical Assay

Test and Troubleshoot

Write and revise SOP’s

LIMS

cGMP, GLP Practice

Process improvement

Protein Purification

R&D,QC,Process Development

Run DOE

ISO 9000 certified

New technology acquisition

Scale up formulation

Equipment Expertise:

Various types of reactors

Various HPLC (RP,SEC,IEX) and SDS-PAGE,ELISA

TOC,Endotoxin Assay, GC,UV/ViS, TLC, LAL, Laser Microscope, Delta V, LIMS

Synced recipe, Liquid Chromatography skid and column,UF/DF skid, and Thermal Analysis instruments -DSC, TGA, DMA, Rheometer, Instron.

Chemicals Safety:

Experience working with highly hazardous chemical, Biohazard and Toxic material, concentrated Acid, Basematerials, highly flammable solvents, Possess excellent safety “consciousness.”

Education/ Trainings:

Bachelor of Science, Major in Chemistry and Minor in Biology, Physics and Math, Gujarat University, Gujarat, India, 1991

Completed Computer training in MS -Word, Excel, PowerPoint programs.

High School diploma, M.R Tata High School, Gujarat, India

Completed training in CPR/1st Aid/AED, cGMP practice, Aseptic Processing, Class 100room, Safety, OSHA, Hazardous Waste Management

Knowledge of Process Excellence, Six Sigma and Lean Manufacturing.

Experience:

Genzyme (Sanofi), Northborough, MA Mar 2015 – Sep 2016

QC Analyst-II

Performed various Plateau (MLC) online training and OJT.

Performed various Wet chemistry assay, Refractometer, Melting point, LOD, Limit test, Nitrate, heavy metal, Titration, moisture content. Western Dot Blot, Raman, Density,conductivity, specific gravity, absorbance base UV/Vis assay

Hand on experience with Raw material Identification and full testing by compendia (USP, EP, JP, and CHP) and non-compendia method.

Responsible for Reviewing, trending and organized test data a professional manner in worksheet and batch record.

Prepared various reagents, gas testing and quarantine materials, strict adherence to cGMP and applicable environment and safety regulation, Adopt Aseptic technique successfully.

Siemens Healthcare Diagnostics Inc., East-Walpole, MA Mar 2014 – Sep 2014

Lab Tech III/ Research Associate

Prepared various Analytical Reagents, Serial dilution, HEPS buffer, managing stability study,

Support for formulation development activities to sensor development project teams.

Performed QC test for reagents and Blood sample on the clinical diagnostics system like blood gas and electrolytes analysis ( Rapid lab 1265, Rapid Point 500)

Run reagents sample on Dimension EXL and Advia centaurImmuno product line Chemistry system to detect creatine, cysteine, and urea nitrate.

Assisted to sensor development Scientist for various electrochemistry related bench tasks.

Responsible for organized test data in Lab notebook and LIMS, reviewing and trending data, graph according to software and generate report summary for Scientist in professional manner.

Support Scientist for lyophilize project and used Keyence laser microscope for membrane 3D-profile study.

Strict adherence to cGMP and applicable environment and OSHA safety regulation.

I have trained on 16Land 80L Fermenter to make large scale reagent batch according to protocol

QD vision Inc., Lexington, MA Sep 2011 – Jul 2013

Process Development Associate

Prepared various NPD batches in 2-liter reactor with air free technic.

Assisted to transfer process from 2Liter scale to 50 Liter matrix scale reactor.

Provide technical expertise and leadership in SME areas, planning, designing idea and conducting experiments, analyzing data and documenting results towards continuous batch process improvement, As well support to reducing recurring deviations.

Responsible for the execution of process operation according to SOP’S, troubleshooting and resolution of equipment issues and process disruptions, developing and implementing process improvement, performing process monitoring, and supporting investigation.

Proficient to extract solvent from QD-Ink formulation using vacuum manifold system and Experience in Synthetic Organic Chemistry.

Tested finish product and stability study samples.

Responsible for Reviewing, trending and organized test data professional manner in Lab notebook and generate test report summary for chemist.

Routine QC-test for premix and final ink batches.

Bristol Meyers Squibb, Devens, MA Nov 2010 – Apr2011

Bioprocess Associate

Completed various Plateau online training and OJT, Strict adherence to cGMP and applicable environment and safety regulation, Adopt Aseptic technic successfully.

Responsible for organized test data in LIMS, reviewing data and SOP’s

Responsible for the execution and changeover of process operation according to SOP’S to run CIP and SIP process and run QXL, HIC, Affinity, TFF, protein purification method in downstream area.

Performed process monitoring, supporting troubleshooting and resolution of equipment issues and process disruptions, and investigation.

Collect and submit in process product sample via LIMS system to QC and Micro. Lab

Completed TFF training at Millipore site.

Assisted to columns pack and unpack process

Henkel Corporation, Billerica, MA Sep 2005 – Sep2009

Sr.Research Associate

Performed and understanding of design-of-experiments (DOEs), analysis and interpretation of data collected of various polymer systems like epoxy, acrylates, and water based binder etc.

Characterized polymers particle size detection via Size Exclusion-HPLC.

Assisted in preparation and characterization of product formulation of conductive adhesives and ink for circuit assembly and printed electronics application.

Characterized and analyzed properties of polymer material and ink (i.e. rheology, reactivity, weight loss, storage modulus etc.) by TA-instruments DSC, TGA, DMA, Rheometer.

Performed accelerated aging characterization of the materials and generated test reports.

Responsible for organized test data in notebook, reviewing and trending data graph according to software and generate report summary for Scientist in professional manner.

Stryker Biotech, Hopkinton, MA Nov 2004 – Sep 2005

Research Associate

Responsible for prep media and various protocols for Analytical assay development scientist and run assay follow the SOP’s.

Completed various OJT, Strict adherence to cGMP and applicable environment and safety regulation, Adopt Aseptic technic successfully.

Performed protein purification via Reversed Phase-HPLC, Ion Exchange-HPLC, Size Exclusion-HPLC

Performed SDS-PAGE electrophoresis analysis of protein and peptide

Performed routine calibration of laboratory equipment

Responsible for organized test data in Lab notebook and the preliminary evaluation of test data for protein purification, Integrated and trending data graph according to software and generate report summary for Scientist in professional manner.

Bio pure Corporation, Cambridge, MA Feb 2002 – Sep2004

QC Analyst

Responsible for the analysis of in process and final polyhemoglobin product including all chemical components and synthesis by product.

Strict adherence to cGMP and applicable environment and safety regulation, Adopt Aseptic technic.

Performed analysis of Hemoglobin binding Efficiency, Cysteine, Glutamine and Hemoglobin Dissociation products via HPLC and Size Exclusion-HPLC for characterize protein molecular size.

Performed all routine buffer, in-process polymerization product and final product via Ion selective Electrode Potentiometer.

Performed all including test as PH, Bio-burden, Osmolality, Conductivity, Endotoxin(LAL), TOC, Elisa, Co-ox, and Spectrometry.

Responsible for organized test data in Lab notebook, the reviewing data, trending data and preliminary evaluation of result.

Performed routine and non-routine preventative maintenance and calibration of laboratory equipment.

MD-Both Industries, Ashland, MA 2000 – 2002

QC-Lab Tech/ Assistant Chemist

Responsible for all quality operations including initial and final product testing follow the cGMP regulation.

Performed various formulations of R&D batches according to SOP’s and protocols.

Performed routine and non-routine preventative maintenance and calibration of laboratory equipment.

Boston Scientific Corporation, Watertown, MA 1999 – 2000

Assembler

Build assembly and subassembly by following procedures and blue prints.

Performed various testing according to SOP’s and inspected components prior to assembly.

Colourtex limited, Surat, India 1992 – 1999

QC Chemist

Raw material testing, final product testing and the product stability.

Characterization, Calibration & maintenance of instruments.

Analytical testing of dyes, intermediates, auxiliaries and organic raw materials using various instructions.

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