Analytical Methods Validation Bio

il y a 1 jour

Wavre, Belgique Jefferson Wells Temps plein

Location:
**Wavre**
**#24072**

**Analytical Methods Validation Bio**
**About our client**
The new Global Quality (GQC&PQ) organization have the goal to bring innovation, integrated capabilities, and speed to our customers through an empowered team that deliver results and enable network success. Within GQCPQ, the Global Quality & innovation team drives Transversal Innovation through multi-sites feasibility, POC & implementation of new technologies for QC Project is to support the feasibility, fit-for-purpose and business cases of new immunoassays replacing current in-vivo potency for DTaP vaccines.
**The missions**
1. To develop, design, perform & analyse new immunoassays (ELISA, Luminex)
(Primary skill).
2. Manage the feasibility & fit-for purpose study including, project management,
business case and reporting & communication to different stakeholders (Secondary
skill)
**Primary Tasks & Responsibilities**
- Manage the feasibility & fit-for-purpose of new immunoassays.
- Perform experimental plan, analyse the results, manage the troubleshooting.
- Manage lab work (training, stock management, data integrity); Work in GMP lab environment.
- Feasibility, fit-for-purpose, and method development design.
- Protocol & report writing.
- Communication of the results
- Project management (stakeholder maping, planification)

**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)
- Preferably minimum 3 years’ experience in the Pharmaceutical Industry with proven lab activities management of and project management
- Capability of working independently and ability to prioritize tasks and meet strict deadlines.

**Knowledge**
- The activity requires a broad and thorough 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 - S/he will be well organized, open-minded, able to work on different projects in parallel, and have a project-orientated spirit. - S/he should have good communication skills in English and an open, proactive personality to work in a team of young international researchers.

**Education, Methodology & Certification Requirements**
- Master, engineer or Ph.D. in biology, biochemistry or immunology.
- Good knowledge in analytical methods
- ICT Skills (software, operating systems, hardware, etc.)
- Microsoft Windows
- SoftMaxPro, Combistat
- Excel or other soft for data analysis (tab, graph, basic statistic) Familiar with MS Office package

**Language Proficiency Requirements**:

- English Fluent
- French is a plus
**Our Offer**
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.

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