Mairead Morris PhD

Experience

• 

  Emer Casey Scholar

  Mar 2009 - Jun 2012

  Doctoral Candidate

  My Ph.D focused on the area of autoantibody assay development to identify autoantibody responses in ovarian cancer patients. Laboratory Methods• ELISA, • Western immunoblotting, • Dot blotting.• Bacterial protein expression (Escherichia coli).• Column chromotography protein purification optimisation.• Buffer exchange and optimisation.• Microarray spotting and screening.• Analysis of large datasets (>10000 readouts).Additional Skills.• Project management - I submitted my Ph.D thesis within 3.5 years highlighting my scientific aptitude and ability to work hard.• Self-starter - I am motivated, results driven and determined.• Team player - I thrived in the cross institutional nature of my work.PublicationsI coauthored 2 peer reviewed publications during my Ph.D (review and original manuscript) along with numerous abstracts presented at conferences. Show less

• 

  Augurex Life Sciences Corp.

  Sept 2012 - Apr 2014

  Laboratory Skills• Design and execute experimental plans.• Analyse results of testing to determine novel biomarker assay utility.• Perform patient serum and synovial fluid testing on Meso Scale Discovery electrochemiluminescent assay platform.• Immunogenic peptide design and development.• Direct polyclonal antibody development.• Perform antibody titre testing using enzyme-linked immunosorbent assay (ELISA).• Antibody sensitivity and specificity testing using dotblotting and Western immunoblotting.• Master sample inventory collating and updating.Statistical Analysis• Good working knowledge of statistical programs such as GraphPad Prism and SAS JMP.• Biomarker sensitivity/specificity and cut-off determination through Receiver Operating Characteristic (ROC) curve analysis.• Univariate/multivariate logistic regression to determine biomarker and clinical variable association with patient outcomes. Show less Laboratory Skills• Citrullination - post translational modification of proteins.• Analysis of mass spectrometry data for post-translational determination.• Development of novel direct ELISA for biomarker determination.• Buffer formulation for different ELISA formats.• Interference testing, heterophilic blocking methodologies.• Accellerated stability testing.• Inter and intra-assay variation.• Assisting with protein purification as needed.• Immunogenic antigen determination, in silico and in vitro.• Western immunoblotting, PAGE analysis.Other responsibilities• Laboratory ordering.• Liaising with industry partners.• Receipt of materials and samples. Show less

  • Associate Research Scientist

    Jan 2014 - Apr 2014

  • Research Assistant

    Sept 2012 - Dec 2013
• 

  Self-Employed

  May 2014 - Jan 2015

  Scientific Consultant

  Data Management• Responsible for Design History File updating.• Maintain and verify electronic master file documentation.• Responsible for verification and quality of clinical data.• Perform statistical analyses and provide reports on findings.• Firmex document management.Communication• Presenting author representing industry partner at EULAR 2014 conference.• Collating scientific data for presentations including late-breaking submissions.• Co-author on conference abstracts and peer-reviewed submissions.• Liaising with clinical collaborators and key opinion leaders as part of research objectives.• Strong MS office proficiency.Laboratory Project Management• Oversee research objectives at 2 overseas sites.• Direct research plan for polyclonal antibody development.• Lead development of diagnostic biomarker assays. Show less

• 

  Integer Holdings Corporation

  Jan 2015 - Jun 2017

  Regulatory Affairs Specialist

  ComplianceComplaint handlingRoot Cause AnalysisCorrective and preventive action21 CFR 803 -Medical Device Reporting93/42/EEC - Medical Device DirectiveMedical Device Vigilance ReportingInternal Audit ManagementSubstantial Change assessment and notificationISO 1348521 CFR 820 - Quality Requirements for Medical Device ManufacturingLead AuditorExperienced Auditee

• 

  Danone Nutricia Early Life Nutrition

  Jul 2017 - now

  Regulatory and Compliance Manager

  FSSC 22000General Food LawHACCP Level 6ABPPCQI