Farzana Quddus

About Farzana Quddus

Strategic Technical leader with 10+ years of experience in Gene Therapy (AAV/Plasmid) and Biologics. Proven track record in leading CMC Quality standards, BLA/IND submissions, and CMO oversight. Expert in implementing QbD principles and statistical process monitoring (JMP) to ensure global regulatory compliance and manufacturing excellence

Experience

1. Principal Engineer, Ms & t

   Sarepta Therapeutics

   Oct 2021 — Present · Bedford, MA, US

   Key Strategic Achievements:Regulatory Governance: Spearheaded the authoring and defense of CMC sections for BLA/MAA submissions; successfully navigated Health Authority IRs using advanced statistical modeling (Equivalence/Non-inferiority) to secure approvals with zero Post-Marketing Commitments (PMCs) for plasmid manufacturing process change.Quality by Design (QbD) Implementation: Established a standardized \"Stage-Gate\" framework for plasmid tech transfers, implementing rigorous starting material checks (%-supercoil/NGS) that eliminated pre-banking failures across the portfolio.Organizational Policy: Authored and implemented corporate-wide Cell Bank Management and Plasmid management policies, standardizing technical quality guardrails across internal sites and external CMO networks.Operational Excellence: Utilized JMP statistical software to drive process comparability and risk-based impact assessments (RBIA), resulting in a 50% reduction in production costs for early stage programs while maintaining 100% compliance.

Education

• Ikkshu Goveshona High School

  SSC, Science

  1998 — 2003

• Ishurdi Girl's College

  HSC, Science

  2003 — 2005

• Bangladesh University of Engineering and Technology

  Bachelor's degree, Chemical Engineering

  2006 — 2011

• Tulane University

  Master's degree, Chemical and Biomolecular Engineering

  2014 — 2015

Skills

• Chemical Engineering
• Matlab
• Laboratory
• Characterization
• Research
• Microsoft Office
• Western Blotting
• Pcr
• Statistics
• Molecular Biology
• Sds-Page
• Microsoft Excel
• Cell Culture
• Management
• Biotechnology
• Process Design
• Molecular Cloning
• Aspen Hysys
• Engineering
• Gel Electrophoresis
• Chromatography
• Purification
• Biochemical Engineering
• Protein Assays
• Process Simulation
• Simulation Modeling
• Dna Electrophoresis
• Bacterial Transformation
• Aermod
• Affinity Chromatography
• Plasmid Purification
• Ultracentrifugation
• Data Analysis
• Mammalian Cell Culture
• Bioreactor
• Delta V
• Cell Counting
• Uf/Df
• Protein Expression & Purification
• Torque Meter