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.
We are looking for a highly motivated Scientist who enjoys working in a multidisciplinary team, has excellent writing skills, and has knowledge of/experience with:
- Extraneous agents (e.g., prions/TSE, viruses and/or microbes)
- Development and validation of cell-culture based and molecular methods (e.g., mammalian cell culture, PCR, sequencing)
- cGXP and/or other quality management systems
- Biopharmaceutical manufacturing
- Regulatory filings
This individual will be responsible for the extraneous agents safety of products developed by Janssen Vaccines Leiden. Furthermore, this individual will ensure method development and validation of in-process control and release methods to be conducted at GMP level in-house and at contract laboratories.
Demonstrating flawless documentation, effective communication with varied levels of the organization, a strong sense of responsibility and a passion for quality are key competences for this position.
- At least 5 years of experience with method development
- At least 3 year of experience with cGXP and/or other quality management systems
- At least 1 year of experience with regulatory fillings
- Speaks and writes fluent English
Janssen Vaccines & Prevention BV (8852)