Scientist Microbiology, Risk assesment, GMP
- Full-time ,
- 32 uur ,
- 24 uur
- Euro 3750 - 4000 ,
- Euro 4250 - 4500
The Analytical Development department within Janssen Vaccines Leiden (one of the pharmaceutical companies of Johnson & Johnson) is responsible for developing methods that are required for analysis of vaccines for human use. Analysis includes testing for identity, quantity, potency, purity and contamination; in particular, extraneous agents safety.
You will be responsible for the extraneous agents safety of products developed by Janssen Vaccines Leiden. Furthermore, you ill ensure method development and validation of in-process control and release methods to be conducted at GMP level in-house and at contract laboratories. This is a hands-off role with as strong focus on risk assessment regarding the process. This will lead to method development and projects in which you take the lead. You will mostly focus on riks assessement/ reduction adice and strategy.
We are looking for a professional with the following background:
- PhD-degree or MSc with publications and excellent writing skills
- Background in microbiology (most relevant areas: prions/TSE, viruses, microbials, in that order) and/or cell biology
- Assay development and validation of cell-culture based and/or molecular methods (e.g., mammalian cell culture, PCR, sequencing)
- Biopharmaceutical manufacturing (preferred)
- Strong background in microbiology
- Minimal 2 - 5 years of experience with method development
- Demonstrable experience with cGXP and/or other quality management systems
- Excellent writing, project managment and communication skills
LabResource is the top tier supplier of Janssen Vaccines and Prevention BV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is dedicated to bringing meaningful innovation to global health.
The Bacterial Vaccines department is working on the discovery and early development of novel vaccines for bacterial infectious diseases. It strives to address unmet medical needs, such as bacteremia (sepsis), meningitis, and respiratory tract and nosocomial infections.
Contract: 1 year via LabResource , realistic long term perspective
Salary: €3800 €4400 gross monthly
Hours: fulltime highly preferred