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Quality Control Lead Immunology - Oferta z Jobs.pl

Badania i Rozwój » Specjalista ds. badań i rozwoju

  • Województwozagranica
  • Miejscowośćinne
  • AdresSwitzerland,
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Quality Control Lead Immunology

Nr ref.: /JOBS.pl


    Develop and lead external or internal technology transfer projects into the Quality Control department.
    Responsible for the execution of analytical immunology test method transfer, optimization and validation to meet project requirements.
    Identify and track critical path/activities and risks, develop contingency and alternative plans and provide regular updates to CMC program lead, project management and Head of Quality Control on immunological methods.
    Participate in project team meetings as assigned.
    Assist CMC Program Lead, project management and Head of Quality Unit to ensure that resources assigned to the project shall deliver according to expectations and client satisfaction.
    Manage project strategy, objectives, specifications, deliverables, timelines and tasks with respect to immunological analytics.
    Work with CMC program lead, project management and Head of Quality Control to ensure resources are committed and available to execute.
    Support Quality Control management to access/acquire required resources.
    Track action items, prepare meeting agendas, coordinate team activities and disseminate project information.
    Establish and monitor project goals as well as go/no-go criteria for all key decision points.
    Write and review test method transfer and validation protocols and reports (including development reports and similarity/comparability assessments) as required.
    Evaluate and capture the productivity and profitability of analytics and data initiatives.
    Ensure relevant knowledge management and documentation management.
    Manage regulatory feedback implementation plan with respect to immunological assays.
    Support immunological analytical strategy (including specification setting and characterization assessment) adapted to development phase as per regulatory interactions/guideline interpretations.
    Perform other relevant duties as required.


    PhD or equivalent immunology, biochemical engineering, biochemistry, biology or related discipline
    Proven experience in functional and binding ELISA
    Relevant biologics experience in an industrial setting under GMP standards; CMO experience is a plus
    Relevant process and QC experience and knowledge of current analytical techniques
    Excellent communication skills and strong diplomacy skills required
    Fluency in English, both written and verbal; French is a plus
    Proven ability to work with flexibility in a changing and demanding environment
    Ability to work independently as well as part of a team
    Demonstrated success with problem analysis/solving, anticipation and proactivity
    Strong sense of discipline and initiative, exceptional planning and organization skills, excellent team orientation and a hands-on approach to work


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