Scientist Regulatory Bioanalysis
Brabant Wallon – Contracting
Your responsibilities?
As a Regulatory Bioanalysis, you will focus on supporting regulatory bioanalysis across our client’s biologics portfolio.
You will contribute by:
- Supporting method validations and sample testing for PK and ADA assays
- 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
- Be responsible as a lab-based scientist for effective method validation and sample testing activities across multiple projects in the Immunology and CNS therapeutic portfolios
Your profile?
Specific skills. competences:
Bioanalysis:
- Extensive hands-on laboratory experience in Bioanalytical validation and sample analysis
Regulatory landscape coverage:
- 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
IT knowledge:
- Experience using Watson LIMS or equivalent LIMS system
- Good knowledge of Microsoft Office
- Graphpad/JMP experience is plus
Minimum Qualifications:
- Master’s degree with a minimum of 6 years of experience as a Bioanalytical Scientist with a proven track record in method validation and sample Testing in support of bioanalytical study phases
- Preferably good knowledgeable in PK(LBA/LC-MS) and ADA analysis
- 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)
Others:
- Very good communication skills
- Ability work cross projects/supervisors
- Attention to detail and quality of work
- VERY well organized, able to function in a complex fast changing environment
- Team player
- Proactive
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
