Madhavi Agarwal is a pharmaceutical quality executive and consultant with 15+ years leading QC strategy, sterile manufacturing compliance, and multi-site operations in FDA-regulated environments.

As Senior Director of Quality Control for sterile injectables, Dr Agarwal oversaw three manufacturing sites and a team of 70 QC professionals across analytical, microbiology, environmental monitoring, sterile manufacturing, stability programs.

Previous to this expanded role, Dr Agarwal was a Director of Global Quality Control at Repligen, where she built and led quality operations across four sites in the U.S. and Netherlands, launched three QC laboratories from startup to go live, and achieved greater than 98% team retention over four years with her team emphasizing excellence and compliance.

Dr Agarwal's specialties include:

• Contamination control strategy,
• Environmental monitoring,
• Aseptic process governance,
• Analytical method transfers,
• Method validation,
• CAPA and change control,
• Digital QMS implementation,
• Digital electronic batch record implementation,
• Lean manufacturing & continuous improvement in pharma and biotechnology manufacturing
• LIMS implementation.

Dr Agarwal has also spent several years working with a variety of cell lines, and is an expert in tissue culture, cell banking, cell potency assays and radioligand binding assays and protein purification and characterization.

Dr Agarwal is a Six Sigma Green Belt, MIT Postdoctoral Fellow, Ph.D. in Molecular & Cell Biology, and Executive MBA candidate at Northwestern's Kellogg School of Management.