Requirements: English
Company: SRG
Region: Braine-l''Alleud , Wallonia
Job Title: Laboratory Scientist
Contract Length: 6 Months - possible extension
Location: Braine-l''Alleud - Onsite (occasional remote work)
Salary: 55k-74k per annum
Hours: 40 hours, Monday to Friday
To strengthen our Regulated Bioanalysis, Precision Medicine team, we are looking for a talented individual to fill the position of: Scientist Regulatory Bioanalysis, based in Braine lAlleud, Belgium (preferred)
As a Scientist Regulatory Bioanalysis, you will focus on supporting regulatory bioanalysis across our clients 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 CNS therapeutic portfolios
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
Interested? For this position youll need the following education, experience and skills:
Minimum Qualifications:
- Masters 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
- 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)
Specific skills. competences:
Bioanalysis
- Extensive hands-on laboratory experience in Bioanalytical validation and sample analysis
- Preferably good knowledgeable in PK, ADA
- Experience with MSD and ELISA platforms
- LC-MS/MS or PCR experience is a plus
Regulatory landscape coverage
- Extensive knowledge of GLP/GCP guidelines as applicable to bioanalysis
- Extensive knowledge of bioanalytical method validation guidelines
IT knowledge
- Experience using Watson LIMS or equivalent LIMS system
- Good knowledge of Microsoft Office
- Graphpad/JMP experience is plus
Others
- Very good communication skills
- Ability to 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