Technologiepark-Zwijnaarde 21, Gent, Belgium
About the job
To strengthen our GMP Quality Control team we are looking for a dynamic full-time collaborator with a passion for quality. The primary focus of the associate scientist is to execute laboratory activities such as release and stability testing related to release and stability testing of a commercial NANOBODY® program.
The GMP QC lab is responsible for method qualification/validation, QC release testing and executing stability studies on drug substance, drug product and placebo batches.
You execute analyses such as (u)HPLC, capillary electrophoresis, UV spectrophotometry, moisture content, osmolality, pH, Biacore, particle counting, … required for release testing, PPQ testing and stability testing for a commercial NANOBODY® program, compliant with GMP regulations.
You perform your activities in the GMP QC Lab according to the local and global Quality System
You assist in drafting and finalizing GMP documents such as system instructions, analysis plans and result reports.
You interpret and report the data according to the methods and compliant with GMP regulations.
You control that the storage of the materials is performed according to the internal guidelines and you assure that shipments of materials from and to Sanofi Ghent GMP QC Lab are executed according to the specific instructions.
You are responsible for the daily maintenance of analytical equipment laboratory supplies and the glassware cleaning
You will plan your daily work independently according to the instructions given by your supervisor.
Qualifications/ Education & work experience
Bachelor or Master's degree in life sciences, with ideally 1 year of previous laboratory experience gathered in the biopharmaceutical industry
Previous Experience with GxP guidelines and a GxP working environment is a plus
Experience in physico-chemical analysis of proteins is an asset but not required.
Experience with common HPLC equipment is an asset.
Team player, enthusiastic, accurate in execution and reporting.
Excellent communication skills.
Practical hands-on mentality
Sense for problem-solving, initiative, continuous improvement, quality, accuracy and detail
Oral and written fluency in Dutch and English
Pursue progress, discover extraordinary.
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