Stephanie Cape, is the Associate Director of Bioanalytical Scientific Operations at Covance, Madison, WI. She received her B.S. in Chemistry from University of IL- Urbana/Champaign in 2003 and her PhD in Analytical Chemistry from the University of Wisconsin- Madison in 2007. Dr. Cape’s graduate research was focused on developing high resolution mass spectrometric methods to enable discovery, characterization, imaging, and quantitation of neuropeptides.
Stephanie joined the field of regulated Bioanalysis as a method development / validation chemist initially at PPD and subsequently at Covance. Within the Covance Bioanalytical team, she has held a variety of leadership roles including oversight of bioanalytical study direction, validation, and method development. Additionally, Stephanie serves as the primary operational lead for on-site regulatory inspections and participates in aligning global SOPs and best practices to industry standards.
What three things would you take if you were stranded on a desert island?
- My family and friends
- A boat
- Rum
If you weren’t a bioanalysts what would you be?
- Not sure- I love that my job is focused on using science and technology to help people- so definitely would find something that incorporates these aspects
What is your favorite city?
Why have you decided to become a Zone Leader?
The Zone website is a great resource and I’m excited to contribute to driving interesting and useful content for the Bioanalytical community.
Journal articles from BioanalysisPanel discussions
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)
Issues facing the bioanalytical community: summary of round table discussions
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Recommendations on incurred sample stability (ISS) by GCC
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