Ajen K. Prasad

About Ajen K. Prasad

Industry Speaker Accolades- 2023, Interphex (New York City)- Implementation of Annex 1 Contamination Control Strategy - 2025, Hanson Wade Cell Therapy Analytical Conference (Boston)- Implementation of new Sterility Strategies for faster and more reliable Cell Therapy ReleaseWith over 20 years of experience in regulated pharmaceutical and biotechnology environments, I specialize in oversight and support of GMP QA and QC operations, including on-the-floor GMP compliance, batch release, quality distribution, supplier qualification, QC method validation, and analytical/microbiological/CCS program management. My skillset has been applied to implementation of quality programs across several modalities, including vaccines, monoclonal antibodies (mAb), cell therapy, bi-specific mAbs, and Antibody Drug Conjugates (ADC). My drive to succeed is rooted in my work\'s potential to help patients, as every day counts, and this mindset has resulted in successful efforts aimed at getting product to patient faster. While working in collaborative cross functional teams, I ensure processes are compliant and in a state of control, to support timely release of product to meet both patient and business needs.

Experience

1. Associate Director, Global Quality, Us & Americas

   BioNTech SE

   Dec 2025 — Present · Washington, DC, US

   Oversee U.S. Quality team that is accountable for batch release and quality distribution of commercial drug product for U.S. and Americas region. Support commercialization efforts by standing up quality operations for U.S and Americas Supply Chain and Distribution, including implentation of contracts with manufacturing/5PL partners and external partners management.

Education

• University of California, Davis

  Bachelor of Science (B.S.), Biotechnology - Microbiology/Fermentation

  2001 — 2005

• Temple University

  Master of Science (M.S.), Regulatory Affairs and Quality Assurance

  2015 — 2016