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Guy GodeauGG

Guy Godeau

CMC New Product Development Quality & Compliance

€ 990/dag
Ittre, BE
15+ jaar

Gemiddelde responstijd: 1 uur

Over Guy

Driven by an unbroken passion for quality CMC, cGMP and leadership domains in biotechnology, I continue to put my skills and 40 years hands-on experience in quality, manufacturing and product development operations to the service of your business. Through my initiatives and responsibilities, I acquired a broad experience in team management, project management and as individual contributor for manufacturing, product development quality and quality compliance of vaccines, biopharmaceuticals, pharmaceuticals and drug-device combination products . I combine these competencies with an appreciated ability to address and succeed with complex CMC, quality and organizational challenges within the organizations and in partnership with externals. I am flexible to work and travel across Europe. Mission in Asia and US might be considered.
  • Engels

    Tweetalig / moedertaal

  • Frans

    Tweetalig / moedertaal

  • Nederlands

    Beperkte professionele capaciteit

  • Hongaars

    Beperkte professionele capaciteit

Kan op locatie werken
Ittre (tot 50km)

Werkervaring

  • UCB
    Independent Senior CMC Quality & Compliance Advisor
    BIOTECHNOLOGIE
    oktober 2024 - februari 2025 (4 maanden)
    Braine-l'Alleud, België
    Senior Quality advisor for CMC development of monoclonal antibodies related to neurology and auto-immune diseases.
    CMC Quality Management New Product Development Project Management Coaching - mentoring
  • QBIOCMC
    CMC Development Quality & Compliance Auditor
    BIOTECHNOLOGIE
    oktober 2024 - Vandaag (1 jaar en 8 maanden)
    Audit of the CMC development program for a new and promising oligonucleotide targeting the Dravet Syndrome.

    Qualification audit of a radiolabelling site for manufacturing of product targeting oncology diseases.
  • UCB
    Director, Head of Global Product Development Quality
    augustus 2021 - september 2024 (3 jaren en 1 maand)
    Coach and lead a team of CMC Development QA professionals (Pharma and Bio Development Quality Leads) to provide leadership, senior expert advice, support and management related to new biopharma product development from candidate selection up to marketing authorization.

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Opleidingen

  • Chemical Engineer for Bioindustries
    Catholic University of Leuven (UCL)
    1982
    Chemical Engineer for Bioindustries
  • Administration
    Solvay Brussels School of Economics and Management
    1990
    Administration

Diploma's

  • Lean Six Sigma Green Belt
    GSK
    2012
    Value Stream Mapping of raw materials and component reception and release process

Vaardigheden

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