After completing her MSc in Medical Molecular Biology and Genetics at Bangor University, Mikaela began her industry career at Qiagen in product development, gaining experience with ISO 13485 for medical devices. She later moved to Bristol and joined Charles River Labs (CRL), where she worked primarily in immunology, and quickly discovered that the skills developed at Qiagen served her well for working to ISO 9001 standards and in compliance with Good Clinical Laboratory Practice (GCLP) guidelines. In addition to supporting preclinical studies across various techniques, Mikaela supported and eventually led bioanalytical method validation for assays such as NanoString nCounter, Luminex, and ELISpot for their use in analysis of exploratory biomarkers in GCLP studies. Over time, her role evolved and she became an Analytical Project Manager, overseeing six GCLP studies across five clinical trials.
After 5 years at CRL, Mikaela left to join MDC in early 2022 to support the development and implementation of MDC’s overarching GCLP framework, leveraging her prior experience in exploratory biomarker analysis. Her focus now primarily lies in continuous improvement and refinement of the GCLP framework, and conducting clinical studies at MDC, from early study conception through to reporting.
