Quality Control Assistant
Resume:
Dhawal Raghuvanshi
Sunnyvale CA, 94086 acudiq@r.postjobfree.com
Career Profile
Goal oriented professional with strong analytical skills as demonstrated by scientific background. Have strong ability to lead projects and perform exceptionally as a team leader and player. Work for a progressive pharmaceutical organization, to enhance and share my skills in areas of drug development in pharmaceutical field. Possess extensive experience in pharmaceutical drug development related studies/techniques with a special focus on quality assurance, formulation, analytical method development, stability studies, quantification in biological samples and basic pharmacokinetics. Excellent written and communication skills as demonstrated by publications and presentations.
Education
Master of Science in Pharmaceutical Sciences, 5/ 2014
University of Oklahoma Health Sciences Center, Oklahoma, OK
Area: Drug development, drug delivery and analytical science
Skills Summary
Scientific skills
Analytical Science / R&D, Formulation, Quality control, HPLC, Drug Stability, Drug delivery, drug designing, document compliance review, Quality approver, Quality assurance
Technical skills
basic SAS, JMP, MS office, MS Visio, MS project, Empower, LIMS, DOE
Research Experience
University of Oklahoma Health Sciences Center Oklahoma City, OK 11/2013 - 5/2014
Research Assistant
•Developed and validated an HPLC method for the quantification of a novel anticancer drug CLEFMA in pre-clinical development stage
•Performed the stability studies of anticancer drug CLEFMA and identified the degradation conditions and mechanisms
•Developed and validated a bio-analytical method for quantification of CLEFMA in biological samples
•Performed a pilot pharmacokinetic study to understand the concentration- time profile of CLEFMA in rat models with the help of the developed HPLC method.
•Design of robust formulations in systemic manner of “design of Experiment” (DOE)
•Formulated and manufactured dry powders for nasal delivery of West Nile Virus vaccine with the help of novel techniques of spray freeze drying
•Characterized the formulated nasal powder in a mono-dose device (APTAR) for particle size, particle diffraction, moisture analysis, bulk and tapped density, morphology etc
•Characterization and screening of excipients on the basis of desired performance of the dosage forms
•Formulation and Development in systematic manner by conducting pre-formulation and stability studies
•Devised a protocol for the inhalation device for conducting inhalation pharmacokinetic study of novel anti- tuberculosis drug CPZEM
Related Experience
Genentech South San Francisco 8/2014 – 02/2016
Quality Control Associate (Compliance)
•Supported method management and technology lifecycle.
•Validated various analytical method for a number of commercial large molecules
•Reviewed QC data for compliance to procedures & specifications, and reported abnormalities.
•Quality approver for various technical reports.
•Compiled data for documentation of test procedures and prepared reports
•Compliance review of GMP document including validation report, technical report and spreadsheet.
•Performed equipment and performance qualification and maintenance for HPLC, pH meter, weighing balance and other equipments.
University of Oklahoma Health Sciences Center Oklahoma City, OK 8/2011 - 11/2013
Lab/Teaching Assistant
•Worked in conjunction with a team of scientists on experiments
•Independently maintained and calibrated lab equipment, ordered supplies for laboratory and monitored inventory
•Instructed undergraduate students for conducting experimental work in pharmaceutics and formulation
Morepen laboratories 6/2010 - 6/2011
Formulation chemist
•Performs analytical method development, and performs analytical method validation according to USP, ICH guidelines.
•Performed stability tests on new product products for both R&D and commercial batches.
•Analysis of Raw material, R & D, Process Engineering, and finished products, using sophisticated instruments like HPLC, UPLC, UV-Vis, and DISSOLUTION Apparatus.
•Performed Method Validation and Method Verification by HPLC (reverse phase, ELSD, SEC, Ion Exchange), UV/Vis and Malvern Particle Size Analyzer.
•Determines physiochemical properties of a number of drug at both pre formulation and formulation stage.
•Analyze data from experiments and evaluate or interpret the experiment results.
•Prepared and Executed Method Validation Protocol documents and Analytical methods.
•Prepared, reviewed and approved a number of Method Validation Reports.
•Analytical testing skills from USP, EP and wet chemical analysis.
•Conduct Solubility studies for BCS Classification.
•Perform Dissolution testing using USP Apparatus I, II, IV(FTC), to support formulation development.
•Extensive knowledge of 21 CFR Part 11, GLP and GMP guidelines.
•CGMP Manufacturing experience.
Alkem laboratories 6/2009 - 6/2010
Quality control Analyst
•Validated a number of HPLC method for finished products.
•Compiled data for documentation of test procedures and prepared reports
Industrial Trainee (Production and Quality Control)
Alkem Laboratories, Baddi, India 06/2008 - 07/2008
Morpen Laboratorie,s Solan, India 07/2008 - 08/2008
Venus remedies limited, Panchkula, India 09/2008 - 10/2008
•Played a major role in the preparation of Annual Product Reviews (APR).
•Excelled in giving line clearances for Dispensing, Production and packaging of various formulations including tablets capsules and injections.
•Reviewing of Batch Manufacturing Records and ensuring Batch Release on time.
•Reviewing of analytical data (QC) for in-process and finished products.
Laboratory Equipment
Scanning electron microscopy (SEM), High pressure liquid chromatography (HPLC) (rpHPLC, SEC, ELSD, IEC and peptide mapping), Capillary electrophoresis, UV-Vis spectroscopy, Karl Fischer moisture analyzer, Zeta-sizer, Spray freeze dryer (SFD), Laser diffraction particle analyzer (RODOS and HALOS), pH meter, dissolution and friability tester. Design of experiment (DOE).
Presentations and Publications
•Hanif SNM, Raghuvanshi D, Durham P, Hickey AJ, Garcia-Contreras L. Pharmacokinetics of CPZEN-45, a novel anti-tuberculosis drug in male guinea pigs. J Aerosol Med 2013; 26: A18
•D. Raghuvanshi, L. Venter, B.T. Johnson, S.N. Abraham, H.F. Staats and L. Garcia-Contreras. Formulation and Characterization of a Novel Dry Powder Nasal Vaccine against West Nile Virus. Poster presentation at GREAT symposium 2012, University of Oklahoma Health Sciences Center
•Rahul Verma, Dhawal Raghuvanshi, Lora C. Bailey-Downs, Alexa Kunch, Michael A. Ihnat, and Lucila Garcia-Contreras. Development and validation of a HPLC method to determine concentrations of a novel anti-cancer compound, DT330 in biological samples. Poster presentation at AAPS 2013, San Antonio, Texas
•Rahul Verma, Mariam Ibrahim, Dhawal Raghuvanshi, Soman N. Abraham, Herman F. Staats and Lucila Garcia-Contreras. Optimization of Spray Freeze Drying Process Conditions to Prepare West Nile Virus Vaccine for Nasal Immunization. Poster presentation at AAPS 2013, San Antonio, Texas
Achievement/Awards/Fellowships
•Research Assistant scholarship from 8/2011 to 5/2014
•Vice-President of International student organization with responsibilities in the planning, organization, development, and leadership of cultural activities of international students 2012-2013
•Excellent aptitude skills as achieved in GRE with 800/800 in Quants (2010)
Professional Memberships/Affiliations
Member, American Association of Pharmaceutical Science (AAPS)
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