(COMPANY NAME) Amatsigroup wishes to enforce its Biological Drug Substance (DS) development and production team with an engineer/scientist for the purification department.
He/She will be part of a team responsible for conducting activities in the field of process development and manufacturing of biologics taking into account the regulatory requirements and clients' needs. The activities are related to downstream processing, involving sample pretreatment, chromatography and filtration steps.
We are looking for a person that collaborates with the (COMPANY NAME) CDMO team in expanding the growth of the company. He/she will report to the Team Leader Downstream Processing of DS Biologics.
* Perform purification activities such as cell homogenisation, fractionation, chromatography, normal flow filtration, tangential flow filtration.
* Contribute to the development of new purification processes for a large range of biologics, including scale-up studies.
* Introduce and report novel techniques.
* Analyse samples from development runs to follow-up the performance of the purification process.
* Responsibility for the interpretation of data and provision of recommendations for further development of scale up.
* Support the transfer of the developed purification processes to the cGMP facility.
* Perform production runs in a cGMP or non-cGMP environment in accordance with the applicable requirements as described in procedures.
* Assist in the creation and maintenance of Standard Operating Procedures and Batch Record Documents.
* Document the work performed in a detailed way and give input for or write first drafts of development reports in collaboration with the Team Leader or Project Manager.
* Participate in the start-up and maintenance and calibration of process equipment.
* Communicate the status of operations to the Team Leader and team members.
* Maintain safe practices and work environment.
* Master Degree with scientific/technical orientation (Pharmaceutical sciences, biochemistry, Bio-engineering, Industrial Engineering).
* Enthusiastic, pro-active, analytical, open-minded, curious and hands-on approach.
* Flexible attitude.
* Be a good communicator within the team.
* Having the skills to present own results in the team meetings.
* Ability to evaluate performed activities and be able to think about and suggest changes/improvements.
* Ability to work independently as well as a member of a team in a dynamic environment.
* Ability to plan own activities based on weekly input from the Team Leader/Project Manager.
* Having a technical feeling to work with complex equipment.
* Fluent in Dutch and English, written and spoken.
* Work in a fast growing organization.
* A position with responsibility within a dynamic company.
* Personal development through learning on the job and additional external trainings.
* A market oriented compensation