Quality Control Project

Ghazal Rahgozar

Aliso Viejo, CA *****

***************@*****.*** 949-***-****

Analytical Researcher / Quality Control Expert / Pharmaceuticals

Seasoned, goal-focused Analytical Chemist with demonstrated track record of quality control (GMP environment) and development and execution of validation protocols. In-depth experience in all quality, analysis, and validation processes.

Leverage outstanding scientific, laboratory and analytical skills to evaluate and revise analytical chemistry methods and validation protocols to improve accuracy and efficiency.

Tenacious problem solver with the ability to correlate diverse, incomplete or contradictory information to produce rapid solutions.

Participate in scientific and research teams in establishing precise project plans to ensure all critical-path/project milestones are completed on schedule.

Consistently demonstrate ability to interact positively with senior management and colleagues with tact and professionalism; recognized for dedication and quality of work.

Proven expertise in analytical testing, generation of accurate findings reports, and managing commercial stability studies.

Professional Skills and Competencies

Stability Study by HPLC and LCMS

Analytical Method Validation

Expertise with Oligonucleotides Testing

Nuclear Magnetic Resonance

Detailed Reporting

FDA and EMA Audits

Optical Analysis

Assay Enzymatic Activity

Organic Mass Spectrometry

Analytical Instrument Calibration

Training

Quality Control Protocols

Professional Achievements

Completed pre-approval inspections (PAI) from FDA and EMA.

Method development for small molecules by HPLC and LCMS.

Conducted research in Oligonucleotide synthesis lab characterizing unknown impurities formed during the oligo synthesis.

Performed ICH stability testing for registration, validation, and commercial batches and composed annual stability reports per ICH stability guidelines.

Provided CMC information to support MAA and NDA filings.

Conducted release testing for commercial product.

Career Experience

Ionis Pharmaceuticals, Carlsbad, CA

Research Associate, 1/2008 – 4/2014

Held responsibility for method development for detecting small molecules in oligo nucleotide by LCMS and HPLC. Authored and executed validation protocols for small molecules in oligonucleotides. Conducted research project from synthesis to characterization of impurity in oligonucleotide. Prepared stability protocols for validation and commercial stability programs, and handled stability testing, and stress testing for oligonucleotides. Generated stability reports with statistical assessment in accordance with ICH guidelines. Completed analytical testing of in-process and finished goods according to written test methods and procedures under GMP environment. Performed purity, impurity profile and assay analysis using LCMS, sequencing analysis of oligonucleotides and complements by LC/TOF, and analytical testing on TOX samples. Conducted validation for analytical test methods, statistical analysis for commercial product using JMP software, and OOS or OOT investigations. Developed analytical methods and SOPs, and authored technical reports to support manufacturing process transfer activity.

Promega Bio Sciences, San Luis Obispo, CA

Analytical Associate Research II, 5/2004 – 1/2008

Conducted a variety of analytical testing following written test methods and procedures. Tested raw materials and in-process and finished goods. Prepared reagents for use in testing. Calibrated and maintained analytical instruments. Performed Bioluminescence assay, and completed enzymatic assay by UV. Conformed chemical structures by NMR and Esquire.

Education and Credentials

Bachelor of Science, Chemistry

ISLAMIC AZAD UNIVERSITY – Central Tehran Branch, Iran

(Certified equivalent of United States granted Bachelor of Science degree.)

Professional Training

Biotechnology

Professional Skills

Liquid Chromatography (HPLC, Reverse Phase, Chiral HPLC), Gas Chromatography, LCMS

Nuclear Magnetic Resonance

NMR: HNMR, FNMR, PNMR,

Assay, ID and impurity profile of Oligo by LCMS

Enzymatic Activity Assay / Fluorescence Assay

Sequence analysis of Oligos by IP-HPLC-TOF-MS

Optical Analysis

Deamination Assay for Oligonucleotides / Oligonucleotide Synthesis

Determination of the Complementary DNA Duplex melting temperature for Oligos

Bio Luminance Assay Enzymatic Activity Assay Enzymatic Activity Assay

Ultraviolet Spectrophotometry Method for Oligo Assay and ID

Organic Mass Spectrometry for peptides and small molecules

Osmolality testing by freezing point Osmometry

Analytical Instrument Calibration

Stability Study by HPLC and LCMS

Karl Fisher Titration, Coulometric Titration

Conduct Analytical method validation

Sodium Test (USP Method)

pH testing

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