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Quality Supply Chain

Location:
San Carlos, California, 94070, United States
Posted:
May 28, 2010

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Fariba raisi

**** ********* ***** ( San Carlos, California 94070

Home: (650) ***-**** ( Cell: (650) ***-**** ( abmqvl@r.postjobfree.com

EDUCATION

Master of Science in Analytical Chemistry, San Jose State University, San

Jose, California

Investigation of folding and unfolding structure of proteins by FT-IR and

NMR spectroscopy

Bachelor of Science in Chemistry, National University, Tehran. Iran

Bio analytical chemist with years of experience process development and

Quality

Strengths include: troubleshooting, studies with strong analytical and

technical expertise

Chromatography techniques (HPLC, GC, CE, GC) ( DNA Synthesis ( Spectroscopy

Techniques (Mass, IR, UV, NMR) (

DNA Sequencing and PCR Techniques

Analytical Operation Management, Protocol preparation & review for FDA

submission, GMP experience, Validation of

Procedures & protocols, Stability study of raw, intermediate & finished

products, Analytical & bio analytical test method

Proficiency,

professional experience

APPLIED BIOSYSTEMS, INC, Foster City, California

Global biotechnology-company providing systems, consumables and services

for scientific exploration.

Senior chemist - Quality Supply Chain March 2007- January 2009

Audited suppliers' manufacturing process and provided reports with full

. risk assessment, critical path analysis, and risk control decisions

matrix

. Ensured quality of raw, intermediate and finished goods

. Applied solutions with cross-functional mitigation and process

improvement tools such as LEAN/Six Sigma to address

complex problems

. Developed procedure to drastically reduce quality issues for incoming

material such as DNA, RNA, Peptide and PCR reagents

. Developed QC protocol and SOP for raw materials and finished goods

. Reduced discrepancy issues related to Hitachi's' capillary array

sequencing machines from 2000 to 155 in 4 months

. Well versed in Quality Regulations FDA 21 CFR 820, and Quality Management

EN13485

Chemist - Process Development, July 2004 - February 2007

. Developed Gene Expression and Genotyping assays using ABI Prism 7900HT

sequencer

. Created customized Human, Mouse and other DNA gene plates for Genotyping

and Gene Expression

. Operated robotic Biomek FX and Hydra dispensers to scale up production of

plates for customers and collaborators

. Operated ABI 3730XL, 3100X, and 310 DNA sequencing systems for sequencing

purification kids

. Validated new products such as Big Dye X-Terminator for DNA sequencing

purification kits

. Developed, troubleshoot and refined test procedures for sequencing

reaction used in functional QC

. Developed stability study protocols to determine the shelf life of Big

Dye X-Terminator

. Trained analytical test method and instrumentations

PAIN THERAPEUTICS, INC. South San Francisco, California

Pharmaceutical company and provider of innovative drugs for pain relief.

Analytical Chemist - QC Department, January 2003 - June 2004

. Developed validation plan, out-sourced validation assignments and

provided input to determine time line

. Analyzed HPLC and Mass Spectroscopy data and troubleshoot to resolve

validation issues

. Validated methods and protocols and assay transfer in accordance with

cGMP guidelines

. Improved the efficiency of QC department by routinely streamlining

procedures and documentations

. Developed stability protocol studies for finish good products

. Created SOP and Certificate of Analysis to achieve GLP compliance

CEPHEID, Sunnyvale, California

Molecular Diagnostics Company that provides fully integrated systems and

tests for genetic analysis in the clinical, industrial, and bio-threat

markets.

Senior Scientist - R&D Department, June 1999 - December 2002

. Developed chemistry for microfluidic system capable of detecting

fluorescent dye-labeled DNA, peptides, and proteins

. Researched and evaluated the effect of different type of disposable

plastic and glass micro-channel chips to improve separation of amplified

DNA by electrophoresis and Isoelectric focusing techniques

. Improved the efficiency of microfluidic system to obtain higher

resolution

. Collaborated with several companies and created wider applications for

the real time PCR on microfluidic systems

. Performed real time PCR on microfluidic systems to isolate and amplify

RNA /DNA sequences



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