BioLyo Technologies is a dynamic biotech company based in Ghent, Belgium, dedicated to the development of live micro-organisms to be used as vaccines or biotherapeutics. The company provides services to third parties to help speed up the development of their Live Bacterial Products (LBPs) by offering GMP compatible and scalable process development. Areas of expertise include medium optimization, fermentation & harvest strategies, and pre-and post-lyophilization formulation of live biological products. Analytical method development to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) plays a key role during process characterization, a service few CDMO’s offer. As a young growing company, BioLyo has implemented a QA system and offers GMP QC testing services used for batch release and stability studies.
BioLyo wishes to strengthen its team with an QC technician.
During the development of an LBP from early to later clinical stages, analytical methods need to evolve from early development to fully validated Quality Control (QC) tests. BioLyo is looking for a Laboratory technician to join the QC team to address the growing number of clients requiring GMP QC testing.
As QC technician you are responsible for developing, conducting and reporting on various QC tests on live bacterial products in a GMP certified environment.
- Write analytical methods, analyze data and write reports.
- Perform lab work according to planning.
- Report directly to the QC Manager.
- Ensure adequate analytical equipment maintenance & qualification status.
- Assist with developing (new) product related assays (cell based, HPLC, microbiological).
- Write method validation protocols/reports.
- Document non-conformities.
- Teach and train technicians in the lab.
- Write SOPs and WINs compliant with the current QA system.
- Organize the necessary hardware, consumables to carry out the analytical work.
- Write WIN, URS, qualification protocol/report for new instruments.
Education and Competences:
- Bachelor degree in pharmaceutical sciences, chemistry, biochemistry or related discipline.
- At least 3 years of experience in the biotech sector, preferably relevant CDMO experience.
- Experienced in working under GMP conditions.
- Knowledge of EP/USP based analytical method qualification and validation is a plus.
- Know-how of statistical data analysis software is a plus.
- Good oral communication and reporting skills.
- Fluent in English and Dutch, written and spoken.
- Critical, problem solving, accurate and precise.
If you are interested in this job offer, please send your application, including your CV and a motivation letter before 2nd of June to Sarah Pattyn, email@example.com.
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