Maggie Aulsebrook
Cofounder, PhD
Areas of Expertise
- Radiopharmaceuticals
- Product development pipeline (from radiochemistry – preclinical – clinical translation – clinical production – reg approval)
- GMP compliance
- Regulatory submissions and auditing
- Development and execution of validation protocols relating to GMP compliance (cleaning, process, equipment)
- Quality management system documentation
Biography
Dr. Maggie Aulsebrook holds over eight years of experience in the radiopharmaceutical sector. She specialises in the development and clinical translation of radiopharmaceuticals in regulated environments. Throughout her career, Maggie has delivered a number of first-in-human diagnostic (PET and SPECT) and therapeutic radiopharmaceuticals to the clinic. Her experience in radiopharmaceutical development spans the entire drug development pipeline from initial radiochemistry studies through to regulatory approvals. Maggie has worked in Europe, the United States and Australia with extensive experience in FDA and TGA licenced environments with experience in the supply of sterile radiopharmaceuticals in the private and public health sectors.
Maggie is currently working on the commissioning of a brand new GMP-compliant cyclotron facility for the manufacture of radiopharmaceuticals in Australia. While the build is taking place, she is developing the operational plan for the facility and the quality management system to ensure a streamlined licencing process by the authority regulator. Maggie holds a PhD in Chemistry and has authored multiple peer-reviewed publications in leading scientific journals.
