ASHISH SOLANKI

** ******** **., **********, ** **854

347-***-****(CELL)

adqe49@r.postjobfree.com

Highly focused, result driven professional with more than 19 years’ experience in pharmaceutical cGMP analytical laboratories. Extensive skills and education in analytical chemistry, including experience in analytical method development, method validation, cleaning validation and cleaning verification of drug substances and drug products. Strong quantitative and qualitative skills in analytical chemistry. Proficient in the operation of HPLC, dissolution apparatus, UV/VIS, FTIR, TOC analyzer, Karl Fischer titration, Total Chrom, and Empower and Shimadzu data acquisition software. Experienced in the procedures associated with system sampling and testing of USP Purified Water. Excellent team player with the ability to work independently in a fast-paced and challenging environment.

PROFESSIONAL EXPERIENCE:

Merck and Co. Inc., Rahway, NJ – (Sept 2021 – Present)

Sr Scientist-1 (Bioassay-Support) – AR & D - API, (via PAREXEL ExecuPharm).

Extensively work with big molecules bio assay seperation with Agilent-1100, 1260 and 1290 HPLC and UPLC H Class and Ion-Exchange Chromatography (IEX separations) with Empower-3 software and SpectraMax with SoftMax 6.5 Software. Bioassay support during development stage samples in GMP and non-GMP stage.

Specific experience:

oAssay of N-glycan Rapi-Fluor using UPLC seperation.

oAssay of N-glycan iPC using UPLC Seperation.

oDetermination of Lipase Activity Assay(LAA)

oCompendial Testing: Appearance Indtrument Clarity, PH, Liquid, Visible Particles

Merck and Co. Inc., Rahway, NJ – (June 2015 – Sept-2021)

Associate Scientist-ADC-API (via PAREXEL ExecuPharm)

Extensively work on assay and impurities tests with Agilent-1100, 1260 and 1290 HPLC and UPLC H Class with Empower-3 software. Test APIs during development stage and stability samples in GMP stage.

Validation work for API development (Precision, Linearity, LOQ/LOD, Specificity etc.) by GC, HPLC and UPLC H Class.

Specific experience:

oResidual solvent test by Agilent 7890 GC with Empower-3 software

oChiral purity (Normal phase) by HPLC.

oChiral Purity by SFC using H-Class (Water) UPLC and Agilent 1260 infinity.

oUse Nicolet 6700 FT-IR and iS50 FT-IR Spectrometer with OMINIC-9 Software.

oUse 756KF Karl Fischer coulometric and volumetric Titration.

oUse 905 Titrando with Tiamo software (0.1N NaOH, 0.1NHCL, 0.1N per chloric acid, 0.1N AgNO3) check initial standardization and re-standardization of standard solution.

oUse UV-VIS-Carry-300-BIO spectrometer.

oPerform ID tests such as ROI (residue on ignition), clarity solution (2100NTurbidmeter) by Nephelos meter, KF (Volumetric and Colorimetric), extraneous matter, etc.

oUse ELN 12.1 (E-Lab notebook) to enter all data, results and reports.

oUse RLIMS for submit release data to quality department.

oPerform annual and semiannual calibration of analytical instrument such as titration and KF, Titration and Nephelos (turbidity test), etc.

AustarPharma, Edison, NJ – (January 2011 – June 2015)

Analytical Chemist-II

Perform method validation and cleaning validation testing under GLP and cGMP compliance environment utilizing tests such as linearity, specificity, accuracy and plate recovery of related substance (impurity).

Perform calibration of HPLC and dissolution bath, Karl Fischer, TOC analyzer, analytical balance, etc.

Responsible for the stability samples inventory, pullout and put in, within required timelines.

Responsible for cleaning verification tests on various products using specific methods.

Daily review of analytical data.

Verify analytical notebooks for accuracy.

Perform routine testing such as assay, impurity, dissolution (Distek and Venkel).

Determine content uniformity on the Perkin Elmer HPLC system, utilizing Totalchrom software.

Perform TOC (total organic carbon) study on purified water using Siever 800 TOC instrument.

Compose and edit SOPs including various methods and protocols.

Packaging material testing experience, (caps, bottles and liner) using FTIR, thickness testing (using Krutkramer MTM10 equipment). Visual inspection, capacity overflow, neck diameter, height, width (using digital caliper) of bottles, caps and liner.

Epic Pharma, Springfield Garden, NY– (January 2010 - December 2010)

R & D chemist II

Perform process method validation and cleaning validation testing in GMP and GMP environment with linearity, specificity, accuracy, plate recovery.

LOD (limit of detection), LOQ (limit of quantization) related substance (impurity), testing.

Perform assay, content uniformity, dissolution (Vankel and Distek) on the

Waters HPLC with Empower software for method verification, process validation and cleaning validation, etc.

Use 25 and 35 Lambda UV/VIS for dissolution and assay and content uniformity.

Perform all the analytical testing with use of SOPs, STPs, and USP procedures and current product protocols.

Experience Prior to 2009 Available on Request

EDUCATION:

Post-Graduate Diploma in Textile Dyeing and Finishing from University of Leeds, North Yorkshire, U.K 1993-94

B.S. Chemistry from P.T. Science College, South Gujarat University, Gujarat State, India 1987-1990

B.S.D.T.C. (Post-Graduate diploma in Textile Chemistry) from M.S. University, Baroda, Gujarat State, India 1990-91

Post-Graduate diploma in Marketing Management form South Gujarat University & HRD Delhi, India. 1997-1998

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