For this Innovative Leading Biopharmaceutical client in Leiden, I am urgently looking for a motivated Process Engineer within the field downstream process development. You will be part the Drug Substance Development group and develops & characterizes processes for purifying and formulating recombinant viruses from harvest as a vaccine production platform.
- Ensure a smooth tech transfer of new products in production (either the CTM pilot plant or production). The tech transfer includes both designing the required study plans, reviewing documentation from production, support during start-up and reporting afterwards. Subsequently you give 2nd line support of running production. Finally,
- You identify possible improvements for increased robust manufacturing and translate this back to development studies.
- As we are transferring our process to several sites over the world, we are looking for some-one who is willing to travel and can give on-site support during the start-up of the plant.
- Process development consists of a USP and a DSP department and is responsible for the development of scalable, pharmaceutical-grade production processes for viral vaccines using mammalian cell lines as a production platform.
- Novel technologies are used to make sure that the processes are safe, reliable, scalable and cost-effective, so that the vaccines can be produced in large quantities at low costs. The developed production processes are transferred into GMP production facilities for the production of clinical batches and scaled-up for commercial production.
- You have a PhD. in a relevant discipline in biopharmaceutical sciences/engineering, biotechnology or chemistry or PDeng.
- A minimum of 3 years’ experience in the industry.
- You have experience with scaling-up/scaling-down of processes, ideally with hands-on experience with DSP unit operations like IEX chromatography and UF/DF
- You have experience with Tech Transfers.
- Experience with scale-up/scale-down of DSP processes
- Both experience with vaccine development and knowledge of GMP are advantages.
- Good communication skills
- Experience with cGMP requirements.
- Preferably experience with Lean/Process Excellence
- Demonstrated communication capabilities and the ability to bridge between production and development and between different development- and production sites
- Data-analysis & report writing
- 1st of November
- 1 year with high change of extension
If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org