Analytical method development skill set, trouble shooting
Resume:
Shruthi S
*** ****** *****, *********** ********,NJ-08854
Email:********.******@*****.***
Summary
Detail oriented chemist with proficiency in the synthesis, formulation and characterization of organic compounds, Stability testing and validation of organic actives in cosmetic products. Highly organized with well-developed communication and time management skills. Keen to apply the skills acquired at a fast paced and research laboratory .
Highlights
●Trained in organic transformation reactions and expert in wet chemistry techniques.
●Hands on experience in HPLC, UPLC,FT-IR, Mass Spectrophotometer, Raman spectrophotometer, UV-Vis Spectrophotometer.
●HPLC and GC Method Validations and Method transfer(Finished products and raw materials)
●Development of methods for Stability and Validation(Cosmetic products ).
●Writing and revising SOP’s and specifications sheets.
●Expertise in SAP & CAPA analysis
●Knowledge in Linux, Windows XP, MS Office, Clinical Database.
●Experience in ChemStation, Empower and LIMS.
●Good communication and quick learner.
Work Experience.
Q C Chemist at L’Oreal,Analytical OTC,USA (Manufacturing Plant.)
Jan 2018 to Present
●Perform Standardization of organic actives for analysis of sunscreens in Cosmetic products using HPLC/UPLC, UV-Vis spectrophotometric techniques.
●Maintenance of Batch records and Calibration of analytical testing instruments.
●Perform raw material testing for elemental analysis using Raman spectroscopy.
●Conduct stability testing, Validation (Accuracy, Precision, Linearity, and Robustness) and method transfer activities by HPLC Chromatography using EMPOWER-3 & Chemstation.
●Develop analytical Method transfers, Method Verification protocols for new OTC products,Finished products and bulk samples.
●Comprehensive understanding of chromatograms, data management system such as LIMS and documentation of testing procedures into Laboratory notebook as per CGMP Regulations.
●Perform Root Cause Analysis, troubleshoot out-of-specification results, and report for OOS investigations.
●Managing SAP & CAPA for Quality system.
Analytical Chemist aT L’oreal, OTC (Research and Innovation).
Aug 2017 to Dec 2017
Conduct Standardization techniques according to USP of organic actives for analysis of cosmetic products according to HPLC & UPLC .
Calibration of HPLC and other analytical instruments .
Perform assay of incoming raw materials used for stability testing.
Method development and Method validation using finished products and bulk goods using EMPOWER 3 softwaree.
Trouble shoot HPLC and UV-Vis analytical instruments.
Documentation of reports and electronic data using Laboratory Information Management Software(LIMS).
Maintain data entry on hazard assesment in SDS authoring system.
QC Chemist at Sansu Life Sciences, Pharmaceutical Company
Jun 2013 to Aug 2015
●Analysis of Routine raw materials according to approved SOP’s using Analytical Measurement Techniques, testing and evaluation per USP, FCC to determine the quality of final product ENSURE for global market research.
●Formulate, develop and confirm peculiar test methodologies for customer’s products.
●Perform Reverse Phase-HPLC method Validation (Accuracy, Precision, Linearity) for estimation of Clonazepam and Propranolol Hydrochloride in Pharmaceutical Dosage Forms.
●Evaluate and provide ingredient formulation adjustments for development of multi-vitamin product improvement.
●Execute experimental design techniques and evaluation of reports.
●Detect abnormalities during performances of tests and reviews.
●Conduct market research on key product and supply global analysis.
●Prepare standards, Test solutions, compounds or reagents for Laboratory personnel to conduct tests.
Laboratory Assistant, GC/MS at Dr. Reddy’s Laboratories.
May 2011 to May 2013
●Validate Analytical Instrument in Quality Control Laboratory in compliance with 21 CFR Part 11.
●Document and authorize SOP’s for laboratory equipment and procedures.
●Perform IQ, EQ and PQ for equipment’s such as chromatographic systems and spectrophotometers.
●Perform routine analysis of protein samples for concentration by UV-VIS by Variable Path Length Technology.
●Perform equipment validation for HPLC, IR-Spectroscopy, cleaning, facility qualifications for all phases to check in accordance with FDA Regulation.
●Manage the Waters 2695 HPLC with Empower Instrument Control.
●Validation of Atmospheric VOC Measurements by Proton-Transfer Reaction Mass spectroscopy using a Gas Chromatography pre-separation method.
●Handle project on GC-PTR-MS in standard mixture which includes calculating the efficiency of GC system.
●Initiated assays, moisture determination, wet chemistry and titrations.
●Research report on quantitative Polymerize Chain Reaction analysis.
Academic Experience
Graduate Assistant, Mississippi College
Jan 2017 to May 2017
●Research project in extraction of essential oils by 5 cinnamon leaves and identification of their volatile composition.
●Conduct research in preparation of essential oils from different species of cinnamon in compliance with the Laboratory Standard Operating Procedures.
●Operate Analytical Instruments and prepared laboratory reports.
●Adhere to GMP guidelines for Laboratory testing procedures.
●Use GC-MS to identify, quantify and analyze Volatile oil composition.
●Perform the Microbiological test for Cinnamon oil extract for presence of E. Coli followed by incubation process.
Teaching Assistant at Mississippi College, Clinton-MS.
Aug 2016 to Dec 2016
●Assist the freshman students in Qualitative research of Prevalence of Brugada syndrome among middle and young and age men.
●Experience in mentoring them to write their research papers in “American Psychological Association” (APA) format.
Academic Projects
Project Assistant at Department of Pharmaceutics at JNTU, India
●Build, maintain and direct the bioanalytical / DMPK laboratory in Pharmacy Department.
●Characterize the contribution of transporters and metabolic enzymes
(phase1&11) to the pharmacokinetic, pharmacodynamics and toxicological behavior of
Primicarb.
●Build a stably trans-infected cell line to characterize the metabolic stability and enzyme kinetics of phase11 metabolic enzymes.
Analysis of Biochemical intermediates in environmental sample using LC/MS, GC/Q- ToF.
●Agilent Scale Fraction collection system to separate aqueous and organic extracts of the sample.
●The Chromatographic analysis by LC/MS by HILIC Chromatography and orthogonal reverse phase columns.
●Data analysis by Agilent Jet Stream (AJS) source followed by MS/MS library searches.
●Identification of compounds by Mass Hunter Molecular Structure (MSC) correlator Software.
Development of Ketorolac Tromethamine in eye drop formulation by Reverse Phase HPLC method using Waters 2695 with 22996 PDA detectors HPLC System with Empower 2 software.
Work done at Chandra Laboratories.
●Formulate and evaluate mouth dissolving Ketorolac Tromethamine for management using disintegrants.
●Perform Spectrophotometric estimation of Ofloxocin and Ketorolac in tablet dosage forms.
●Detection of compounds by UV-Visible Spectrophotometer using Photo-diode array.
●Validation of method according to ICH guidelines.
Synthesis of Oxazines from Chalcones and Evaluation of their Antibacterial activity
●Synthesis and design of novel Oxazine derivatives for significant activity against HIV-1 mutant strains.
●Develop experimental designs and characterizations of series of non- nucleoside reverse transcriptase inhibitors.
●Synthesis and characterization of heterocyclic compounds involving transition metal catalyzed reactions.
●Exploring Multi-step synthesis of chemical transformations in Organo-lithium reactions.
Education
2017 Master of Health Services Administration Specialization: Clinical Research, Qualitative Analysis, R&D. Mississippi College, Clinton, MS.
GPA: 3.7/4.0
2015 Bachelor of Pharmacy: Chemistry
Jawaharlal Nehru Technological Institute., Hyderabad, India.
GPA: 4.0/4.0
Publications
“Synthesis of Oxazines from Chalcones and Evaluation of their antibacterial activity”
World Journal of Pharmacy and Pharmaceutical science. Volume 4, Issue II 886-895 –ISSN no: 2278-4357, Nishk Laboratories.
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