Devashree Desai Email & Phone Number

New York, Ny, Us

Lawrence Township, Nj, Us

New Brunswick, Nj, Us

New Delhi, In

o Performed analysis of in-process, finished & stability testing of controlled release solid dosage formso Performed blend uniformity, content uniformity, assay, impurity, dissolution using HPLC, UPLC, dissolution apparatus like App I, APP IIo Performed method validation & method transfer for assay, impurities and dissolutiono Assisted in the investigation of deviations during analysis and write investigation reporto Initiated stability testing for development & commercial samples by labeling and placing samples into stability chambers along with related paperwork as per ICH and regulatory guidelineso Pulled out stability samples from stability chambers according to analysis schedule and monitor temperature and humidity for stability chamberso Write and revised SOP, analytical methodo Experience writing stability and validation protocols & reports o Reviewed analytical data for completeness and correctnesso Supported to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submissiono Assures that technical and regulatory CMC issues are appropriately resolved.o Experience working in the GMP compliant environment, maintaining laboratory notebooks and following Analytical and Standard Operating Procedures

Summit, New Jersey, Us

o Performed release and stability testing of drug substance and drug productso Performed appearance, assay, impurity, dissolution testing, std requalification and related wet chemistry analysis using the following instrumentation: HPLC, UPLC, pH meter, dissolution apparatus App I, APP II under GMP environmento Reviewed analytical data to ensure that testing is competed according to appropriate analytical method and SOPo Reviewed laboratory equipment and reference std logbooks for accuracy, completeness and adherence to cGMPso Reviews and updates SOPs as neededo Performed laboratory inspection to assure compliance with cGMPso Assisted in the investigation of out of specification result during analysis to find out root cause of deviationo Supported regulatory CMC group by providing stability and analytical reportso Performed data entry and data tracking by using LIMS o Experience working in the GMP compliant environment following analytical procedures, maintaining electronic laboratory notebooks and worksheets

South Plainfield, Nj, Us

o Performed analysis of finished & stability products of semisolid dosage formso Performed IVRT development, validation and comparison using automated Franz-chin diffusion apparatus for cream and ointmento Performed assay, degradation product testing and related wet chemistry analysis using the following instrumentation: HPLC, UPLC, Viscometer, pH meter in the GMP environmentso Performed method validation & method transfer for Assay, Preservative and degradation productso Assisted in method development for assay and degradation profileo Experience writing and reviewing stability data and reportso Experience writing analytical method, SOP, validation protocol, validation reporto Reviewed certificate of analysis for reagents & reference standardo Experience working in the GMP compliant environment, maintaining laboratory notebooks and following Analytical & Standard Operating Procedure

o Performed analysis of in-process, finished & stability products using HPLC, UPLC, UV/VISo Performed blend uniformity, assay, impurity, content uniformity, dissolution & water content analysis of solids & transdermal patcheso Worked on various dissolution apparatus like App I, App II for tablets & capsules, App V and App VI for transdermal patcheso Performed physical testing for Transdermal Delivery system like peel test, tack test, shear test, burst testo Method validation for Assay, Impurity & Dissolutiono Complied with all cGMP, cGLP, DEA, OSHA & company in house policies & SOPo Experience working in the GMP compliant environment and maintaining electronic notebooks

Boonton, New Jersey, Us

o Development of downstream purification processes for various peptides in a GMP/GLP setting using an AKTA system and Unicorn softwareo The processes include various techniques including IEX, RP, Amidationo Perform routine HPLC analysis and prepared buffers to support downstream purificationo Peptide characterization by Amino Acid Analysis, HPLC and Enzymatic or Chemical Digestiono Revised SOPs, reviewed batch records and laboratory data for accuracy and completenesso Provided support and participate in tech/GMP manufacturing runs of peptide

Boonton, New Jersey, Us

o Performed analysis of in-process and finished products. Conducted investigations on customer complain sampleso Performed analytical tests : Assay, content uniformity, impurities testing of solid dosage for release, stability studies and cleaning validation using HPLC , UV/VIS, Karl fischer o Performed tests for solid dosage forms such as Dissolution, assay, content uniformity, impurity & water contento In accordance with established GMP's, GLP's and SOP's, performing quality control testing on Nasal Spray like spray pattern, Droplet Size Distribution, Pump Delivery, Osmolality, Assay & Impurities using HPLCo Performed stability testing for Fortical Nasal Spray, Enzyme & peptides like sCT & PTH according to stability protocol within specified time periodo Calibrated pH meter, analytical balances, dissolution apparatus, UV Spectrophotometer, HPLC, electronic pipetteso Reviewed data generated during analysis of pharmaceutical products in a timely & efficient mannero Reviewed certificate of analysis for reference std & reagents used in laboratoryo Experience working in the GMP compliant environment, maintaining laboratory notebooks and following Analytical and Standard Operating Procedures

Brookville, New York, Us

Thesis Study: Evaluated Dermatological Topical Dosage Forms of Ketoconazole with Reduced Levels of Drug and Enhanced In-Vitro Drug Release Prepared different formulations of 1% Ketoconazole using various topical bases like HPMC Gel base, Nonionic Emulsion base.Investigated prepared formulations for the in-vitro drug release and compared with 2% commercial Ketoconazole product in-vitro drug release data.Comparative evaluation of drug release using cellulose membrane and human cadaver skin as barriers by using Franz-chin diffusion cellGenerated drug release profiles by using UV/VIS and HPLC

Master'S Degree, Pharmaceutical Sciences (Industrial Pharmacy)

Bachelor'S Degree, Pharmacy