Scientist Data

Arpita Chhatrapati

** ******* ****, **** *********, NJ-08816

Cell: 908-***-****; e-mail: advzan@r.postjobfree.com

PROFILE

Analytical Scientist with wide experience of Research and Development and Quality Control in Pharmaceutical fields with a fully cGMP, GMP and GLP compliant environment.

Expertise in complex products such as depot injectable and suspensions.

Good analytical skills and experience in validating methods in line with FDA and ICH guidelines.

Expertise in writing Method Validation Protocols, Reports and Analytical methods.

Good Quality Control skills and expertise in ANDA Batches and Commercial Release testing.

Certified Data Reviewer for GMP study skill.

Managed In House instrument calibration for HPLC and UPLC.

Expertise in all test tools and techniques in a pharmaceutical laboratory.

Excellent management skills: able to manage and train many team members in laboratory.

Used LIMS for Quality Control Commercial release and stability testing.

Strong problem solving and troubleshooting skills.

Great ability to function well within multidisciplinary teams.

Strong technical knowledge and outstanding communication skills.

Ability to work with formulation scientist.

Can work under high pressure environment with efficiency.

Excellent knowledge of the U.S. ICH guideline, GMPs, GLP and FDA cGMP guidelines.

SKILLS

Hands on experience with chromatographic data acquisition software: (Detectors – UV, PDA and RI) with Empower 3 Software and Total Chrome. Agilent HPLC and UPLC system and waters HPLC.

Dissolution apparatus, Hanson, Biodisk, Karl Fischer Titrator, UV/VIS, Infrared Spectrophotometer, Malvern Mastersizer, Zeta Sizer and Gas Chromatography.

MS Office (Microsoft Word, Excel and PowerPoint), LIMS, Nicholen program for online SOP reading.

PROFESSIONAL EXPERIENCE

Scientist-II (R&D- Injectable) Auromedics, Dayton New Jersey Sep 2017 - Present

Completed Validation work for Finished Products and excipients.

Performed accelerated In-Vitro released for long-acting Injectable products.

Completed all Tech Transferred work to Quality Control Lab.

Performed Validation works for all types of Analytical test methods which are proposed by ICH guidelines.

Performed Molecular weight analysis by using Size Exclusion Chromatography for biodegradable polymers and water-soluble polymers for complex injectable formulation.

Performed Reference Listed Drug characterization along with final formulation with In-house analytical methods. Prepared reports on Comparative In-Vivo pK data.

Used LIMS for Quality Control testing. Updates Excel for new Raw Materials and chemical inventory every month. Handling Control Substances with CII and CIII.

Scientist, Sunrise pharmaceutical, Rahway New Jersey Mar 2017 - Sep 2017

Performed all required testing for Commercial Release and Commercial Stability testing including Raw Material testing.

Performed Blend Uniformity for in-process samples and Content Uniformity for finished Products from Commercial batches.

Performed all qualifications for In-House Standards and performed instrument calibration.

Ability to reviewed the batch records, coordinate and prioritize work in an efficient manner.

Completed audit tasks within specified time frame without errors.

Performed testing for FDA deficiency for filing product.

Scientist, Catalent pharma solution (Cardinal Health) Somerset, NJ Feb 2004 - Jan 2017

Performed all required testing for ANDA batches, Clinical Stability and Commercial Release Stability.

Performed Blend Uniformity for in-process samples and Content Uniformity for finished Products from small scale up batches and Process Validation batches.

Performed method evaluation, verification, and validation as per full ICH guidelines.

Performed Linearity, Accuracy, Precision, Specificity, Robustness and Solution Stability for Assay, Related Substances and Dissolution test, Low level Accuracy for Related Substances.

Followed strictly compliance of approved QC Laboratory testing procedures, drug product, method validation, analytical method, and stability testing.

Executed multiple tasks such as operated HPLC, UHPLC, Dissolution UV vis and Karl Fischer.

Supported Formulation Development by analyzing samples for small batches for evaluation.

Prepared reports for in-house Validation work and Drafted Method after Validation work is completed.

Actively participated in laboratory investigations and troubleshooting to identify possible causes for OOS results.

Created reports using Trackwise system for Out of Specification results, Lab Error and Lab Investigation and any Deviation.

Reviewed Data for ANDA filings and Commercial Release testing.

Prepared In-house SOP, Test Protocol for clinical and Commercial Stability.

Prepared COA and Data Summary Report for Stability Data Trending.

Efficiently managed daily schedule to meet deadlines, Detail analysis and critical thinking resulting in accurate, complete and timely release of in process and finished products.

Exhibited multiple tasks such as perform lab work, train analysts in reference to documentation performances in real-time, review of notebooks and comparison of all results to specifications prior to issuance of the final study report or Certificate of Analysis (COA).

Responsible for working on formulation/process development, technology transfer, manufacture of clinical trial material, scale-up and commercialization activities for new drug products for New Drug Applications (NDAs) and generic drug products for Abbreviated New Drug Applications (ANDAs).

AR&D chemist, PLIVA Inc. East Hanover, New Jersey Nov 1998 – Dec 2003

Performed analytical testing of drug substance and products using various analytical instruments such as HPLC, UV/VIS, Karl Fischer, IR Spectrophotometer and Dissolution apparatus.

Responsible for the analysis of stability, in-process samples and finished products by assay, impurity, thin layer chromatography, moisture, content uniformity, IR, Loss On Drying, hardness, friability, Disintegration, pH, dissolution profile of solid dosage forms by manual and auto sampler methods.

Prepared analytical test methods, method development reports, evaluation reports, method transfer protocols and specifications.

Reviewed notebooks and calculations as per test methods. Standard Operating Procedures and compared all results to specifications prior to issuance of final reports.

Analyzed organic and inorganic compounds to determine chemical and physical properties, composition, structure, relationships, and reactions, utilizing chromatography, spectroscopy, and spectrophotometry techniques.

Developed, improved, and customized products, equipment, formulas, processes, and analytical methods.

Conferred with scientists and engineers to conduct analyses of research projects, interpret test results, and develop nonstandard tests.

EDUCATION

Bachelor of Science –Chemistry Gujarat University, India June 1995

ACCOMPLISHMENTS

Achievement award of 5S kaizen event.

Award of excellence by Cardinal Health-2005.

Cypher Program certificate of appreciation by Cordis-Johnson & Johnson company-2004.

Customer focus award by Cardinal Health – 2004.

Certification in High-Performance Liquid Chromatography.

Certification in LSS white belt training and yellow belt training

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