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Mary Ryan

Mary Ryan

Global Contract Manufacturing Intern

Followers of Mary Ryan566 followers
location of Mary RyanCounty Cork, Ireland

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  • Timeline

  • About me

    GxP Inspection Management | Quality & Compliance | Risk Management | Life Sciences | Driving outcomes for patients through collaboration, innovation, and effective partnerships.

  • Education

    • University College Cork

      -
      Master of Business Studies Management & Marketing

    • University of Limerick

      -
      Specialist Diploma Regulatory Affairs (BioPharmaceutical)

    • University College Cork

      -
      Bachelor of Science Chemistry

      Activities and Societies: Public Relations Officer, U.C.C. Chemical Society Ireland – U.S. Council Scholarship awarded by University College Cork

  • Experience

    • Pfizer

      Jun 2009 - Aug 2009
      Global Contract Manufacturing Intern

      • Product launch planning of contract manufactured generic products in preparation for patent expiry.

    • Intertek

      Jan 2012 - Jul 2012
      Project Analyst

      • Coordination and execution of contract bioassay testing.

    • ESI Technologies Ltd

      Apr 2013 - Jun 2016

      Contracted at: BioMarin Pharmaceutical Inc., Shanbally, Cork, Ireland. • Created, implemented and managed site spares strategy for start up manufacturing. • Owner and technical lead of aseptic product portfolio.

      • Project Engineer

        Oct 2014 - Jun 2016

      • Product Support Engineer

        Apr 2013 - Oct 2014

    • BioMarin Pharmaceutical Inc.

      Jun 2016 - Sept 2024

      • A member of the global GxP Compliance Strategy team responsible for health authority GxP inspection management, including readiness, execution and post inspection commitment activities.• Scope includes GVP (pharmacovigilance), GCP (clinical), GMP (manufacturing), GLP (pre-clinical laboratory) and GDP (distribution) regulatory inspections. • Inspection support for BioMarin regional offices and third party GxP inspections (e.g. CMOs, CTOs) • Purification operational readiness lead for process performance qualification (PPQ) manufacturing campaign. • Purification scale up and manufacturing process design for clinical product campaign.• Project lead of various site continuous improvement initiatives. • Manufacturing support during regulatory inspections and internal audits. • Execution of purification process operations for PPQ & commercial product manufacturing. • Process robustness study lead ahead of new product PPQ campaign. • Compliance with GMP requirements whilst helping meet manufacturing production goals.

      • Associate Director, GxP Compliance Inspection Management

        Mar 2024 - Sept 2024

      • Senior Manager, GxP Compliance Inspection Management

        Mar 2022 - Feb 2024

      • Manager, GxP Compliance Inspection Management

        Nov 2020 - Feb 2022

      • Process Engineer, New Product Introduction

        Aug 2017 - Nov 2020

      • BioTechnician (Purification)

        Jun 2016 - Jul 2017

  • Licenses & Certifications

    • Women Leaders: Advancing Together

      Harvard Division of Continuing Education
      View certificate certificate

  • Volunteer Experience

    • Industry Engagement Sub-Committee Team Member

      Issued by ISPE Ireland Affiliate on Jan 2021
      ISPE Ireland AffiliateAssociated with Mary Ryan

    • Team Builder - New Delhi, India

      Issued by Habitat for Humanity Ireland on May 2011
      Habitat for Humanity IrelandAssociated with Mary Ryan

    • Team Builder - Malawi, Africa

      Issued by Habitat for Humanity Ireland on Jun 2010
      Habitat for Humanity IrelandAssociated with Mary Ryan

    • Chemistry Tutor

      Issued by University College Cork, Ireland (UCC) on Sept 2007
      University College Cork, Ireland (UCC)Associated with Mary Ryan