Scientist-II

Arpita Chhatrapati

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

Cell: 908-***-****; e-mail: *****************@*****.***

PROFILE

Analytical Scientist in Pharmaceutical field with wide experience in Research and Development and Quality Control with cGMP, GMP and GLP compliant environment.

Expertise in method development and testing of complex products such as depot injectables, nano- suspensions injectable and oral solid doses.

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

Expertise in writing Method Validation Protocols and Reports, Analytical Method Development Reports and finalized Analytical Methods after Validation.

Expertise writing reports for DOE and QBD batches for finalizing the formulation for lab scaleup batches.

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

Certified Data Reviewer with depth knowledge of GMP study, FDA and ICH guidelines. Review including Commercial release products.

Managed In House instrument calibration for HPLC and UPLC.

Expertise in a variety of analytical test tools and techniques in a pharmaceutical laboratory.

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

Used LIMS for Quality Control Commercial release products 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, assisted in preparing formulations of DOE batches at R&D.

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: Empower 3 and Total Chrome.

Agilent and Waters HPLC and UHPLC system (with Detectors – UV, PDA, and RI).

Size exclusion Chromatography (SEC) for polymeric materials, Dissolution apparatus (USP-I, II, IV, VII), Karl Fischer Titrator, UV/VIS, Infrared Spectrophotometer, Particle Sizer (Malvern), Zeta Sizer and Gas Chromatography.

PROFESSIONAL EXPERIENCE

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

Developed and validated analytical test methods for several complex injectable products such as peptide loaded biodegradable polymer (PLGA and PLA) based microspheres and injectable nano-suspension products for 1- and 3-Months depot injections.

Performed analytical testing of R&D formulations efficiently for speedy formulation development.

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

Compiled all Stability data for final formulation R&D lab size batches and prepared reports for Product Development.

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

Based on literature and guidelines, developed accelerated In-Vitro release tests (Dissolution) for long- acting injectable products.

Technology transfer of the developed methods and validation to the manufacturing facility located outside the US.

Prepared Technology Transfer Document (TTD) package for API, Excipients, Finished product included all methods, specification, stability Protocol and Dissolution protocols for F1 and F2 studies required for FDA submission.

Prepared R&D reports for supporting Product Development Section for regulatory filing such as Development and Justification of Dissolution methods (accelerated in-vitro), Photo stability, Freeze thaw, Impurity Comparison with RLD.

Performed FT-IR comparison with Reference listed Drug with final Formulation Batches with Pallet as well as with Mineral Oil.

Updated spreadsheets for raw materials and chemical inventory. Handled Control Substances inventory of Class-II and Class-III materials.

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 review 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 filed product.

Scientist, Catalent pharma solution (Cardinal Health, CDMO) 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 are 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 performing lab work, training analysts in reference to documentation performances in real-time, reviewing of notebooks and comparison of all results to specifications prior to the 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 and 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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