Madison is a pharmaceutical microbiologist who has experience in the manufacture of a range of pharmaceutical formats including non-sterile liquids, topicals, and sterile injectables.
Madison’s experience includes working with a team to design and qualify a clinical drug product manufacturing facility. She has experience developing an environmental monitoring program for an ISO classified aseptic manufacturing facility and established an on-site microbiology laboratory. She has also been responsible for site-wide aseptic operations training and gowning qualification programs.
Madison has led numerous investigations into environmental monitoring non-conformities utilizing risk management to identify and mitigate contamination risks. She has implemented important changes to facility design, procedures, and personnel training to optimize the process and minimize contamination risks.