Consultants' Network

Dr. Nadine M. Ritter is a highly accomplished professional with extensive technical expertise in cell and molecular biology, protein biochemistry, and immunology. After a decade in academic research of bone development (including NASA space shuttle studies), she transitioned into biopharm industry analytics. Her positions have included being an analytical R&D scientist for a multinational biopharm company, the director of a landmark contract R&D/GMP/GLP analytical testing division, and a senior CMC consultant for a prestigious biologics consulting firm. 

For the last 30 years, Ritter has been involved in training, consulting, and auditing roles for biotech and biosimilar products, and has played a key role in numerous international regulatory filings and post-approval change protocols. She has also made significant contributions to laboratory quality activities and compliance remediation efforts. She has been instrumental in co-founding industry forums and has served in leadership positions in professional organizations. She has co-authored numerous book chapters and journal articles on analytical methods and laboratory quality for biological products. She is a former president of the CASSS Board of Directors and was awarded as a CASSS Distinguished Fellow in 2022.