Analytical Method Validation
Il y a 5 mois
**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)**:
- **Perform experimental plan, analyze the results, manage the troubleshooting**:
- **Manage lab work (training, stock management, data integrity)**:
- **Work in GMP lab environment**:
- **Protocol & report writing**:
- **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**:
- **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**:
- **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**:
- **High learning ability**:
- **Autonomous, resilient with an execution focus**:
- **Flexibility, tenacity, curiosity**:
- **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**:
- **Master, engineer or Ph.D. in biochemistry or immunology**:
- **Good knowledge in analytical methods ICT Skills (software, operating systems, hardware, etc.)**:
- **SoftMaxPro, Combistat**:
- **Excel or other soft for data analysis (tab, graph, basic statistic)
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