Regulatory Consultant, Merck KGaA
Natika Calhoun is a regulatory Subject Matter Expert for biological APIs, virus and gene therapy products, antibodies, linkers, and antibody-drug conjugates, based in California, USA. In her current role, she consults on regulatory topics and works directly with customers as a Regulatory liaison to support technical writings, filings, and submission success for biological products.
She previously served as the site Head of Quality for MilliporeSigma’s viral vector manufacturing site in Carlsbad, California, USA, where she was responsible for leadership of the Quality unit, and for preparing the facility for commercial and inspection readiness to support its first FDA and EU licensed products, which resulted in successful FDA and EMA inspections. With over 25 years of Quality and Regulatory experience, Natika brings a strong background in aseptic processing, GMP manufacturing, and leading regulatory inspections. Natika holds a B.S. in Biology from UC, San Diego, M.S. in Biology – Molecular Cell Science from U. of Memphis, and Certificate in Biotech Management from Vanderbilt Univ., Owen Graduate School of Business.