Experience

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  MSD Ireland

  • Ireland
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Regional Operations Lead for Next Generations Network EUCAN Region

    • Jan 2023 - Present

    Define and coordinate and regional strategies and prioritiesFoster collaboration across the regional and global leadershipLead and support regional and global events/initiativesIdentify opportunities to promote local initiatives across the regionGuide and coach the LT of 17 chapters in the region: - Standardize operations across the chapters- Facilitate sharing and networking across the chapters

  • AR&D Metrology Group Lead

    • Sep 2022 - Present

    Building the AR&D compliance teamCoordination of equipment qualification for the AR&D laboratorySite Lead for QMS chapter 7.2 and successful implementation

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  MSD Switzerland

  • Switzerland
  • Pharmaceutical Manufacturing
  • 400 - 500 Employee

  • Chapter Lead for Next Generation Network - Switzerland

    • Oct 2020 - Oct 2022

    Building and leading the NGN Switzerland core team (14 teammembers across all sites in Switzerland)Strategy planning in alignment with global NGN strategy and MSD Switzerland strategyFurther establish a culture of belonging to ONE MSD in SwitzerlandFoster collaboration with other EBRGs in SwitzerlandFoster collaboration with other NGN chapters in EuropeSupport newly formed NGN chaptersOrganization of various events and initiatives (e.g. Site Insights in WAG, Citybay, and Weystrasse, Speaker Event on MSD in Emerging Markets, Speaker Event on Microsoft Teams and Presentation Skills, Speaker Series on Drug Product Development, NGN After Office Events)

  • External Capabilities & Compliance - AR&D

    • Sep 2021 - Sep 2022

    • Responsible person for the global Center of Excellence for Comparator Blinding: global project management, outsourcing management (coordination with different departments and CROs including resource planning), formulator for blinding comparators for the entire company, author of RED memos, author / reviewer for CMC regulatory chapters in submission documents (IND , IMPD)• Global harmonization of comparator blinding workflow and respective testing requirements• Establishment of a long term strategic partner for placebo manufacturing and analytical testing• Responsibility for establishing a new CMO/CRO for Drug Substance manufacturing as well as analytical testing in Europe: Technical oversight of projects, establishing a local team dedicated to MSD/MERCKLeading the API GMP Repository in Switzerland: supervision of cross-functional team, oversight of repository and sub-division process, area representative in SwissMedic inspection, global process harmonization and implementation of innovative technologies

  • Global Project Manager & CRO Manager - AS/PharmSci

    • Jun 2019 - Sep 2022

    • Responsible person for the global Center of Excellence for Comparator Blinding: global project management, outsourcing management (coordination with different departments and CROs including resource planning), formulator for blinding comparators for the entire company, author of RED memos, author / reviewer for CMC regulatory chapters in submission documents (IND , IMPD)• Leading cross-functional “Lessons Learned” to support process optimization

  • Rotational Assignment External Development & Manufacturing - OFS/PharmSci

    • Mar 2021 - Dec 2021

    • Responsibility for global project management for external manufacturing and development, outsourcing management (coordination with various departments and CMOs), review/approval of pre-executed (master) batch records, author of specification files, review/approval of executed batch records, author of planned manufacturing deviation and rework/reprocessing memos, author of change management records, review/approval of CMO investigations, initiation/performing of internal investigations• Leading cross-functional “Lessons Learned” to support process optimization

  • Deputy Lab Head Polymerics Lab– AS/PharmSci

    • Jun 2018 - Sep 2021

    • Deputy Lab Head: Overall Responsibility for the Polymerics laboratory (including data review, result reporting, laboratory tours, training and supervision of new employees)• Project management for the implementation of the Next Gen IVR systems at WAG (5M $ project): Coordination of MSD internal work (coordination and technical support of equipment installation/qualification, assessment and implementation of EHS requirements) and external collaboration with the vendor (planning of resources, budget planning and realization, service negotiation and planning) including financial management• Analytical IVR support (e.g. compiling and presenting results) for GMP, but also for non-GMP and R&D batches in global cooperations• Method development and method validation (incl. issuing supporting documents and final reports)• Responsibility for budget planning and implementation for the department: participation in the creation of contract changes and comparison with the global budget, preparation of investment applications (CIRs)• Author of various local and global SOPs and other regulatory documents• Responsibility of Data Integrity Initiatives for the department• Responsibility for Quality and Compliance for the department (e.g. deviations, change control, and cross functional lab investigations), including audit support• Responsibility for Quality Risk Management (e.g. monthly Site Quality Risk Management Committees, Risk Assessments) for the department• Contribution to various innovation projects (e.g. software & hardware upgrade of the dissolution technology, implementation of a cloud-based data analytics and data repository dashboard through global cross-functional cooperation, blockchain techonlogy based data repository)• Defect Elimination Site Co-Lead

  • Event Manager Next Generation Network Switzerland

    • Jun 2017 - Sep 2020

    Organization of multiple events and initiatives for all employees in Switzerland- External Speaker Event in Bourbaki Cinnema on the future of the health care industry- WAG Site Insight- Monthly After Office Events (Suite Bar, Christmas market, barbecue at the beach)

  • Scientist Polymerics Lab

    • Mar 2016 - Jun 2018

    - Support of FIH studies of various polymeric dosage forms by performing IVR release and stability testing on different dissolution systems independently as well as compiling and presenting results for GMP, but also for non-GMP/R&D batches in global cooperation with other sites- Method development and method validation (including issuing supporting documents and final reports)- Equipment Ownership and responsibility for GMP status (e.g. planning, performing, and supervising regular re-qualifications and maintenance, performance of equipment qualification and review of qualification documents including SDLC)• EHS assistant: EHS awareness within the site, represent the site in monthly global meetings and quarterly global safety councils with LT members, Site representative in the European community of practice, member of the global AR&D safety committee, member of the MRL global safety advisory committee, SME for EHS Standard on Chemical Management

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  Omya

  • Chemiker-Technical Services & Innovation - Life Sciences

    • Nov 2015 - Feb 2016