Scientist Regulatory Bioanalysis

Il y a 7 mois

Brainel'Alleud, Belgique Jefferson Wells Temps plein

Location:
**Braine-l'Alleud**
**#21974**

**Scientist Regulatory Bioanalysis**:
Contracting - Braine-l'Alleud

Our partner is looking for a **Scientist Regulatory Bioanalysis** to join its teams. This international company is well known for its pharmaceutical products.

**Your responsibilities?**:
**As a Scientist Regulatory Bioanalysis, you will focus on supporting regulatory bioanalysis across the company biologics portfolio.**

**You like to work in an** **environment **where you can**:

- Be responsible as a lab-based scientist for effective method validation and sample testing activities across multiple projects in the Immunology and therapeutic portfolios

**You will** contribute** **by**:

- Running validation, and sample testing experiments.
- Delivering needs for pre-clinical and clinical studies
- Work with method development scientists for the successful transfer of assays.
- Maintenance of the GLP quality system as well as being involved in optimizing and reshaping the quality system as a function of new activities,/workflows being implemented

**Let's talk about you **:

- Master’s degree with a minimum of 2-3 years of experience as a Bioanalytical Scientist with a proven track record in method validation and sample Testing in support of bioanalytical study phases
- Experience working in regulatory environment (GLP/GCP) where the quality is paramount would be critical
- English thorough knowledge, both spoken and written (French will be considered as a major advantage)
- Extensive hands-on laboratory experience in LBA validation and sample analysis
- Preferably good knowledgeable in PK, ADA and biomarker analysis (especially ADA experience is valued)
- Experience with MSD and ELISA platforms
- LC-MS/MS experience is a plus
- Extensive knowledge of GLP/GCP guidelines as applicable to bioanalysis
- Extensive knowledge of bioanalytical method validation guidelines
- Experience as principal investigator in pre-clinical and clinical studies
- Experience using Watson LIMS or equivalent LIMS system
- Good knowledge of Microsoft Office
- Graphpad/JMP experience is plus

**Our offer?**:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

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