My leading Biopharma Client in Leiden is looking for a Lead USP Scientist to oversee several projects for USP development. This is an opportunity to work in a driven dynamic team, in the center of the Dutch biopharma market. This position is on-site in the Netherlands - remote work is only possible 1 day per week.
- Interact with internal/external stakeholders on a regular basis to translate requests into work packages, experiments or actions, coordinating the work internally and update on progress of USP development.
- Ensure development of a reliable and robust USP process for GMP Manufacturing. Providing information on CMA's, CPP's, specs and input for tech transfer to GMP Manufacturing, for process validation runs and trouble shooting.
- Execute, set-up, or provide advice on effective experiments (QbD if required) to a small team of Associates and Scientists in process- and analytical development
- Write or review development protocols, draft-SOP's, Batch Records and reports to ensure consistent quality and reliable data and information (eg ALCOA+)
- Give input to process transfer to GMP manufacturing and define/give project specific training to operators, provide input and coordinate Process Validation runs
- Train USP Associates and Scientists depending on your experience level on the job or contribute to internal knowledge sharing initiatives
- Masters/PhD in Biosciences, Biochemistry, Bioprocess Engineering, Biotechnology, or related; with 7+ yrs of work experience (mostly in development)
- USP development in a bio pharmaceutical production/manufacturing environment
- Experience with suspension cell lines, lab scale to 1000L bioreactor preferably single use, production of recombinant proteins, (viral) vaccines and antibodies.
- Strong stakeholder management capabilities
- Ideally June/July
- Initial contract 12 months with extension/potential to transfer to permanent contract
Get in touch ASAP by sending your CV to email@example.com or call me on +31202044502! You can also refer a friend and both earn 250 Euros on placement.