Summary
Overview
Work History
Education
Skills
Websites
Googlescholar
Highlightedskills
Timeline
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Faezeh Sedighi

San Diego,CA

Summary

Accomplished Scientist with over 10 years of experience in biotherapeutics and AAV gene therapy, specializing in molecular biology and analytical assay development. Proven track record in designing and implementing cutting-edge experimental approaches, optimizing AAV vectors, and ensuring regulatory compliance. Adept at leading cross-functional teams, driving scientific innovation, and translating complex data into actionable insights to advance gene therapy programs.

Overview

9
9
years of professional experience

Work History

CMC Scientist II

Kate Therapeutics
12.2023 - Current
  • Managed the development and implementation of analytical and molecular biology-based assays to support both upstream and downstream process development within CMC team
  • Led the Design and optimization of PCR-based assays, including transgene-specific primer-probe design, performing and troubleshooting qPCR and ddPCR assays for accurate and consistent vector genome titer, design and performed PCR based assay for residual DNA quantification
  • Spearheaded the development of fast, robust methods for DNA integrity and purity assessment and capsid VP protein ratio evaluation using the PA800 Sicex application, significantly reducing analysis time compared to traditional alkaline and SDS-PAGE gels
  • Directed the execution and analysis of SDS-PAGE and alkaline gel electrophoresis for evaluating viral protein and transgene impurities
  • Implemented and authored SOP of in-house ELISA assays for engineered capsid titer quantification and empty/full capsid ratio evaluation
  • Designed ELISA assays for host cell protein and nuclease residuals for in-process and Drug substance samples
  • Led the transfer of analytical methods to a Contract Research Organization (CRO), overseeing method validation documentation to ensure the development of robust, reliable, and reproducible methods
  • Coordinated with the CRO to communicate deadlines and priorities, ensuring timely execution and successful delivery of methods.

Vector Analytical Scientist I & II

Codexis Inc
01.2021 - 10.2023
  • Led AAV quality control and AAV vector evaluation assays, focusing on critical quality attributes and animal biodistribution analysis, advancing CNS AAV capsid development (HTP and LTP) through the preclinical phase
  • Executed and resolved challenges in AAV vector evaluation assays, including vector genome titer and residual DNA analysis via qPCR and ddPCR
  • Optimized and troubleshot DNA/RNA tissue extraction protocol using the Kingfisher instrument enabling efficient and precise biodistribution analysis (RT-PCR and qPCR) of mouse tissues
  • Screened animal plasma and performed cytokine profiling and in vitro transduction inhibition assays for pre-existing immunity to engineered AAV capsids, ensuring the selection of suitable candidates for in vivo studies and immune response analysis
  • Developed and successfully implemented high throughput Bio-layer Interferometry (BLI) assays for quantifying AAV capsid titer verified by ELISA assays
  • Performed and troubleshot biophysical methods for viral protein ratios and impurity assessment via CE and SDS page techniques
  • Conducted size distribution aggregation analysis, and isothermal stability (Tm & Tagg via DSF) utilizing Stunner and Uncle Platform supporting capsid protein production and preclinical development
  • Authored and reviewed SOPs for product quality control, playing a key role in supporting Research and Development (R&D) activities
  • This encompassed in-process and release testing for materials, contributing significantly to Codexis' product development and release efforts
  • Developed, validated, and transferred bioanalytical and stability assays focusing on enzyme activity, impurity identification, characterization, and quantification, adhering meticulously to ICH Q2 Guidelines.

Research Assistant

West Virginia University
08.2015 - 12.2020
  • Conducted a comprehensive investigation into the effects of natural and chemical modifications on Huntingtin protein aggregation and its interaction with lipids associated with Huntington's disease
  • Investigated the impact of posttranslational modification on huntingtin protein potency and formation of toxic fibrillar structure using advanced Atomic Force Microscopy, Circular Dichroism (CD), LC-MS, and Western Blot
  • Developed and optimized a chemically crosslinking protocol to study the kinetics of oligomeric species formation of the huntingtin protein
  • Executed and optimized E
  • Coli vector expression and protein purification protocol utilizing affinity chromatography, and assessing protein purity through Western Blot and SDS-PAGE gel analysis
  • Implemented and optimized a range of immunoassays, including ELISA, Western blot, dot blot, and filter trap assays, for precise detection, quantification, and characterization of soluble proteins.

Education

Ph.D. - Biochemistry And Biophysics

West Virginia University
Morgantown, WV
12.2020

Master of Science - Physical Chemistry

Isfahan University
Isfahan, Iran
12.2013

Bachelor of Science - Chemistry

Shiraz University
Shiraz, Iran
05.2007

Skills

    AAV vector genome titer, capsid titer, viral protein ratio purity and safety analysis: qPCR, ddPCR, RT-qPCR, Alkaline gel, ELISA, Biolayer Interferometry (BLI-Octet), Western Blot, Jess, CE (Sciex PA800), SDS-Page, Endosafe

    AAV biophysical characterization, full/empty content ratio, aggregation: HPLC, SEC, AEX, DLS size distribution, SLS aggregation, and isothermal stability screening (DSF) via Uncle and Stunner platforms

    Tissue collection, biodistribution analysis, and histology: Geno/Grinder, King Fisher DNA/RNA extraction, and Immunofluorescence staining

    Mammalian cell culture and cell-based assays: Transfection, transduction, immunogenicity, and existing antibody neutralization assays

    protein-protein interaction and binding assay: UV-Vis and fluorescence-based assays via microplate Reader

    Gel extraction and DNA purification: Qiagen QIAquick kit

    Automated liquid handling: Biomek and Tecan

    Working knowledge of GMP (ICH guidelines) and SOP development

Googlescholar

https://scholar.google.com/citations?user=1UIN-X0AAAAJ&hl=en

Highlightedskills

  • AAV vector genome titer, capsid titer, viral protein ratio purity and safety analysis: qPCR, ddPCR, RT-qPCR, Alkaline gel, ELISA, Biolayer Interferometry (BLI-Octet), Western Blot, Jess, CE (Sciex PA800), SDS-Page, Endosafe.
  • AAV biophysical characterization, full/empty content ratio, aggregation: HPLC, SEC, AEX, DLS size distribution, SLS aggregation, and isothermal stability screening (DSF) via Uncle and Stunner platforms.
  • Tissue collection, biodistribution analysis, and histology: Geno/Grinder, King Fisher DNA/RNA extraction, and Immunofluorescence staining.
  • Mammalian cell culture and cell-based assays: Transfection, transduction, immunogenicity, and existing antibody neutralization assays.
  • Protein-protein interaction and binding assay: UV-Vis and fluorescence-based assays via microplate Reader.
  • Gel extraction and DNA purification: Qiagen QIAquick kit.
  • Automated liquid handling: Biomek and Tecan.
  • Working knowledge of GMP (ICH guidelines) and SOP development.

Timeline

CMC Scientist II

Kate Therapeutics
12.2023 - Current

Vector Analytical Scientist I & II

Codexis Inc
01.2021 - 10.2023

Research Assistant

West Virginia University
08.2015 - 12.2020

Ph.D. - Biochemistry And Biophysics

West Virginia University

Master of Science - Physical Chemistry

Isfahan University

Bachelor of Science - Chemistry

Shiraz University

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