Nadine M. Ritter, PhD Global Biotech Experts, LLC

Nadine M. Ritter, PhD

Nadine M. Ritter, PhD Global Biotech Experts, LLC

Nadine Ritter has been a protein scientist for over 30 years, with 10 years basic academic research in bone biology followed by 20+ years in biopharma CMC analytics.

She received her BS in Biology/Chemistry from the University of Houston – Clear Lake, and her MA and PhD in Cell and Molecular Biology from Rice University, followed by an NIH postdoc at the University of Texas – Houston.

Afterwards, she joined the biotech industry as a senior scientist at Abbott Laboratories for the development, validation, tech transfer and troubleshooting of protein analytical methods for a wide variety of proteins and peptides. Later, she became Director of Analytical Services at one of the first biopharma analytical CROs, BioReliance, where she managed contract R&D, GLP and cGMP laboratory operations in standard and state-of-the-art physiochemical and functional methods of analysis.

In 2014, she launched Global Biotech Experts, a technical, regulatory and quality consultancy for biopharma products.

For the last two decades, Nadine has been a writer, speaker and trainer in CMC analytical science and laboratory compliance for biotech products. She is on the Board of Directors of CASSS, and is a founding member of the CASSS CMC Strategy Forums. She is a member of the BioAB of PDA, and contributed to the PDA Method Qualification TR. She has been on the editorial board of BioProcess International from its inception, and has numerous publications on biotechnology analytical methods and laboratory quality practices.

Nadine is frequently invited around the world to speak, consult and train for biotechnology product development, post-market changes, and compliance requirements for testing laboratories.