Challenging position for an experienced DSP engineer / scientist.
Job description
The 'Down Stream Processing' department forms part of the Drug Substance Development group and develops & characterizes processes for purifying and formulating recombinant viruses from harvest as a vaccine production platform. These processes must be safe, scalable and economically viable. They will be implemented in a GMP pilot plant facility for the production of clinical trial material and scaled-up for commercial production.
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. All activities are performed in close collaboration with other departments.
Responsibilities
- We are looking for a motivated Process Engineer/Scientist who can design DSP studies and make sure that they can be executed.
- You will represent DSP in multidisciplinary project team(s), being responsible for process development in that project, in close connection to all relevant stakeholders.
- In order to develop the process, you translate research goals into actions and accomplish the targets by delivering study designs and study plans, analyze data and write or coordinate scientific study reports, all in close connection with the customer.
- You ensure a smooth tech transfer of new products in production (either the pilot plant or production)
- you give for 2nd line support of running production. In addition, you identify possible improvements for increased robust manufacturing and translate this back to development studies.
Requirements
- MSc or Pdeng in chemical engineering, microbiology, organic chemistry or similar life science related field with minimum of 5 years of hands-on operational DSP experience (lab, pilot and/or production scale), relevant DSP unit operations are Filtration, Chromatography and UF/DF.
- Experience with scale-up/scale-down of DSP processes
- Good communication skills
- Experience with cGMP requirements.
- Preferably experience with Lean/Process Excellence
- Enthusiasm to support production by hands-on presence during production (sometimes traveling required)
- Pragmatic
- Demonstrated communication capabilities and the ability to bridge between production and development
- Data-analysis & report writing
- Quality, efficiency, accuracy and reliability of work
Benefits
- Contract: 1 year through Oxford Global Resources, realistic long term possibilities
- Salary: €3400,- till €4200,- gross monthly based on level of experience;
- Hours full-time preferred 32h discussable;
- Holidays: 25 (+12);
- Startdate: Asap;
Referencenr:15525
