Data Analyst

VIDHI PARIKH

*** * **** ******, **** *** Email: adcg81@r.postjobfree.com

Milpitas, CA - 95035 Contact No: 732-***-****

Work Experience:

Intarcia Therapeutics, Hayward, CA (Jun2019-Present)

Scientist

Design and execute experimental studies in support of research and product development.

Author and review deviations and CAPA for OOS/OOT investigations

Keen knowledge of global cGMP, cGLP and FDA regulations.

Continue conducting stability studies for new clinical lots; reviewing stability protocol, executing stability protocol and stability pulls.

Proficient using JMP for statistical analysis of stability data for trending.

Perform Data integrity review check and perform QC check for document for NDA filing.

Perform analytical testing using various equipment: Karl fisher, Viscometer, UV, HPLC, Particle size Analyzer, Particle counter, Densitometer etc.

Author, review and approve stability reports, analytical forms, Analytical method etc.

Lead analyst for method validation and method transfer activity to commercial lab.

Co-ordinate sample receiving and sample management with other departments.

Actively involved in Pre-Approval inspection activities.

Intarcia Therapeutics, Hayward, CA (Oct2016-May2019)

Associate Scientist

Developed and validated analytical method for Particle size distribution for in process suspension and final product using Morphology G3 analyzer.

Performed water content using KF Carl fisher for both powder and suspension product.

Performed other analytical methods using following instruments: UV spectrophotometer, HPLC, Kinexus Rheometer, pH testing, Density meter

Troubleshoot and execution of in-vitro release rate experiment for Device

Conducted stability studies to support product development.

Author technical reports, summarizes, protocols, SOPs, and analytical methods.

Reviewed and approved analytical testing data.

Lead in DIR process for NDA filing.

Intarcia Therapeutics, Hayward, CA (April 2016-Sept2016)

QC Analyst

QC data verification/chromatogram review project

Review chromatograms and make sure the peak values off the graph match the data in the tables for an NDA filing.

Responsible for reviewing and approving technical documents such as method validation/verification protocols and reports, release and stability testing data sheets, laboratory notebooks and SOPs.

Proficient using eDMS system VESTA.

Got trained for GMP guidelines.

Renovel Discoveries (Nag Research Laboratories), Fremont, CA (March 2013- April 2014)

Research associate (Volunteer)

Perform protein analysis assay such as ELISA

Submit ELISA results using Prism GraphPad.

Preparation of various Buffers and Reagents.

Write and update SOPs.

Maintain accurate and detailed scientific notebook of all experiments performed.

Ohlone College Project, Fremont, CA (Jan 2013-May2013)

Cloning and Transformation of Putative membrane surface antigen BspA-Like gene from Trichomonas vaginalis

This Independent research Project includes- Selection of gene of interest, Primer designing, PCR, DNA extraction, Gel electrophoresis, Cloning and Transformation.

Genencor, Palo Alto, CA (Nov 2012- Feb 2013)

Intern

Hands-on work in the laboratory

Preparing solutions & reagents, serial dilutions

Independently working on media preparation and Autoclaving

Keeping accurate records in notebooks

Government Science College, Gujarat- India (June 2009 - July 2010)

Lecturer and Lab Incharge

Conducted lectures on Molecular Biology, Biochemistry, Immunology and Microbiology

Handling Autoclaving, Media Preparation, Microbiological Sample preparation, inventory check etc.

Acquired hands on skill in isolation and estimation of DNA, Gel electrophoresis, PCR of isolated DNA, TLC of proteins, isolation and purification of enzyme, estimation of enzyme, ELISA, Immunodiffusion techniques.

Experience working in BSL2 Biosafely microbiology lab

Cadila Pharmaceuticals at Dholka, India (May 2008 – August 2008)

Intern

Took training on following instruments: GC, HPLC, UV absorption spectrophotometer, FTIR, atomic absorption spectrophotometer, Dissolution tester, disintegrator, etc.

Cadila Pharmaceuticals at Kadi, India (May 2005 – July 2005)

Intern

Took training on ELISA and studied Vitro Enzyme linked Immunosorbent assay for the Quantitative measurement of protein level in Serum, Plasma, Cell lysate and urine.

Education:

Certificate of Achievement in Biotechnology: Quality Control and Research Associate (May2013)

Ohlone College- Fremont, CA

Masters of Science in Biochemistry (June 2009)

Gujarat University, India

Bachelors of Science in Biochemistry with vocational Biotechnology (May 2007)

Gujarat University, India

Computer:

Proficiency in operation of personal computers and software packages like Microsoft Office.

Use of MS Excel to create spreadsheets, graphs and statistically analyze data (i.e. averages, standard deviation, student t-test).

Knowledge of DNA sequencing software such as BLAST, FASTA.

Achievements:

Participated in Lean White belt workshop for Kaizen projects.

Participated in State level seminar on current trends on environmental science at N.V.Patel college, Anand, Gujarat

Awarded best poster award on Stem cells at Gujarat Cancer and Research Institute(GCRI) in 2007

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