Analytical Method Validation
il y a 1 semaine
Primary tasks & responsibilities are to manage the feasibility & fit-for-purpose of new immunoassays:
Feasibility, fit-for-purpose and method development design:
Project management (stakeholder mapping, planification
):
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Perform experimental plan, analyze the results, manage the troubleshooting:
Manage lab work (training, stock management, data integrity)
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Work in GMP lab environment:
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Protocol & report writing:
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Communication of the results Experience, Knowledge & Soft Skill Requirements Experience:
Demonstrated proficiency one or more of the following areas: Immunoassay development, validation (for QC), Project management, Lab activities, Data analytics (including calculation method)
Knowledge:
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Preferably minimum 3 years' experience in the Pharmaceutical Industry with proven lab activities management of and project management:
Knowledge of immunoassays including development, validation and method troubleshooting:
Strong interest and experience in immunoassay and scientific software development:
Experience in software use (SoftMaxPro, Combistat, PLA, Gen5, )
Soft Skills:
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Strong problem-solving skills, profound background in scientific analytical method:
Well organized, open-minded, able to work on different projects in parallel, and have a project orientated spirit:
Good communication skills in English and an open, proactive personality to work in a team of young international researchers:
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High learning ability:
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Autonomous, resilient with an execution focus:
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Flexibility, tenacity, curiosity:
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Effective time management, ability to clearly identify priorities and manage multiple tasks:
Open to interact with other departments such as Quality Control and Analytical R&D:
Enthusiastic, positive approach with an open mind for local/global issues:
Capability to prioritize tasks and meet strict deadlines
Education & Requirements:
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Master, engineer or Ph
D in biochemistry or immunology:
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Good knowledge in analytical methods ICT Skills (software, operating systems, hardware, etc.)
:
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SoftMaxPro, Combistat:
- **Excel or other soft for data analysis (tab, graph, basic statistic)
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