For one of the pharmaceutical companies of Johnson & Johnson. The Analytical Development department 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.
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.
Essential requirements for the function as a Scientist Microbiology:
- 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);
- cGXP and/or other quality management systems;
- Biopharmaceutical manufacturing (preferred);
- Must have excellent writing skills;
- Enjoys working in a multidisciplinary team.
- PhD-degree or MSc with publications and excellent writing skills;
- Minimal 2 – 5 years of experience with method development;
- Demonstrable experience with cGXP and/or other quality management systems.
This position is a secondment role, starting with a year contract. There is anticipated for a long term commitment. You must be eligable to work in the Netherlands.
More information about the Scientist Microbiology? Please contact Leonie Koomen at Leonie@heraklespharma.nl or 06-1051 83 23.