Software Office

SANDIP PATEL, Ph.D.

** **** ***** **, ******, NJ 08820, Cell : 732-***-****

Email : adhzk9@r.postjobfree.com

PROFESSIONAL SUMMARY

Highly motivated pharmaceuticals professional having over 10 years of progressive experience in pharmaceutical analytical R&D/CMC/QC activities from development phase to commercial launch for Oral solid drug products (Tablet and Capsule), Semi-solid drug product (Gel, Cream, Ointment), Liquid solutions (Oral and Topical), Suppository, Injectable, and Oral suspension (Powder for suspension).

Innovative knowledge of ICP-MS (PerkinElmer), Extensive experience with method development and validation of Elemental Impurities for the drug product of Oral solid drug products (Tablet and Capsule), Semi-solid drug product (Gel, Cream, Ointment), Liquid solutions (Oral and Topical), Suppository, Injectable, and Oral suspension (Powder for suspension).

Strong skills in planning research activities and timely achieving project goals.

Knowledge of Mass Spectrometry, High Performance Liquid Chromatography, Thin Layer Chromatography.

Fully compliant with cGMP, GLP, OSHA and DEA regulation.

Ability to learn and adapt to new domains and new technologies very quickly.

SIGNIFICANT ACCOMPLISHMENT

Implemented elemental impurity In-house testing strategy in drug product and individual component for successful compliance with the new regulations. In-house elemental impurity testing significantly reduced the amount of testing that must be performed routinely, resulting in saving cost.

Method development and validation of Assay for the drug product of Oral solution, Oral suspension for powder by ICP-MS.

Proficient in the use of analytical technique and instrumentation including ICP-MS, UPLC, HPLC, UV Spectroscopy, GC, Malvern, IR, AA Spectroscopy, Dissolution.

Excellent knowledge of Computer System, MS Office (Excel, Word, Power Point).

PROFESSIONAL EXPERIENCE:

Senior Scientist

Quagen Pharmaceuticals LLC-Analytical Development, West Caldwell, NJ

01/03/2019 to Present

Perform literature research to develop analytical methods to test pharmaceutical drug products, drug substance and cleaning verification methods.

Identify the potential elemental impurities as per ICH Q3D, develop the method to control the elemental impurities and provide justification for elemental impurities in the drug product.

Experience of operation, maintaining, calibration and trouble shooting of ICP-MS.

Perform method development for assay, impurity, dissolution, cleaning verification, preservatives of solid, semisolids, oral solution formulation products.

Support the product development team by analyzing the product development samples, excipient compatibility samples and stability samples.

Experience of Reverse engineering in RLD product.

Experience working with ICP-MS software Syngistix version 2.4, HPLC software like Empower 3, Empower 2, Class-VP, AAS software WizAArd, LabSolution, PinAAcle.

Experience of handling control substance (CII, CIII).

Prepared analytical method validation protocols and analytical method validation reports for drug substances and drug products for ANDA submission.

Prepared standard operating procedure for laboratory equipments including its calibration, operation and preventive maintenance.

Senior Chemist

Heritage Pharma Labs-QC, Method Validation, East Brunswick, NJ 09/12 to 01/02/2019

Validate analytical Testing methodology for Raw Materials and Drug Product.

Analytical Method Validate for the Determination of Elemental Impurities by ICP-MS.

Conduct analysis of Raw materials, APIs, In-process samples, Finish products and Stability samples by performing various test as Assay, Blend uniformity, Impurity, Dissolution, Content uniformity.

Performed Method Validation and Process Validation for Assay, Dissolution and Impurities by ICP-MS, HPLC, AAS and UV-Visible Spectrophotometer using In-house SOP.

Working experience with PDA, RI Detector, Conductivity Detector, ELSD, UV Detector.

Working on various dosage forms like Hard-gelatin capsules, Soft-gelatin capsules, Injectable, Tablets, Suspensions.

Calibration of instruments including HPLC, Dissolution unit.

Performed technology transfer of analytical method between R&D and QC department.

Analytical Chemist

Alembic Pharmaceuticals Limited, Gujarat, India 03/2007 to 02/0208

Synthesis & Analysis of Erythromycin Derivatives like Azithromycin, Clarithromycin, Roxithromycin and Venlafaxine.

Analysis of Drugs using various lab equipment like HPLC, UV-Visible Spectrophotometer, IR Spectroscopy, Thin Layer Chromatography, pH meter.

Operation, Calibration and Trouble shooting of analytical instruments.

Chemist

Raymon Gelatin Pvt. Ltd, Gujarat, India 05/1999 to 05/2001

Gelatin : Viscosity, pH meter, Conductivity, LOD.

Assure quality by performing tests and analysis during different stages of manufacturing and Packaging.

Record test results on standardized forms and writes test reports describing procedures used.

EDUCATION:

Ph.D in Chemistry

Synthesis, Characterization and Antimicrobial Activity of some Mixed-Ligand Complexes

Sardar Patel University, V.V. Nagar, Gujarat, India 06/12

MS in Organic Chemistry

Gujarat University, Gujarat, India 03/06

References : Available upon request

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