Brenda C.

Brenda C. is a seasoned professional in Quality Assurance and Regulatory Compliance with extensive experience in the biotech and medical device industries. Currently serving as Senior Manager of IMP Manufacturing Quality Assurance at BioNTech SE, Brenda C. manages collaborations with contract manufacturing organizations (CMOs) for cell therapy and peptide production while overseeing batch disposition and the review of critical documentation. Previously, in a similar role at Athersys, Brenda C. was responsible for reviewing complex technical batch records and regulatory documents, significantly improving operational efficiencies and ensuring the quality of materials for clinical trials. With a strong background in quality management systems, auditing, and training, along with a solid educational foundation in Biology and Chemistry from Cleveland State University and additional certifications in Immunology and Pharmacology from Harvard Medical School, Brenda C. has a proven track record in the field of quality assurance and clinical compliance.