Downstream Process Development Scientist

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Ferring Pharmaceuticals

With a Quality by Design (QbD) approach in mind and by using state-of-the-art equipment (e.g. ÄKTA Pure, Krosflo FS-15 etc.), perform process development activities including membrane/resin chromatography and filtration (NFF and TFF) experiments to develop robust and lean Biologics processes fit for technology transfer to CMO and clinical material generation
Be involved in the implementation of the pilot scale DSP capacity and perform pilot scale activities (200 L batch purification)
Analyze data, report results and progress to the head of DSP and team, troubleshoot and propose a way forward
Write and/or review laboratory-related and DSP-related SOPs, work instructions and protocols in English
Write and/or review experimental reports, development/tech transfer reports, meeting minutes and presentations in English
Be involved in the implementation of the Quality systems, the procedures and the instructions supporting IND/BLA submissions
Be accountable for lab area and equipment. Make sure that equipment is maintained and calibrated. Make sure that stock of chemicals/consumables is at right level
Propose means for process and yield improvements, including the use of new technologies
Implement lean tools in the lab such as 5s at the bench

Experience in the purification of Biologics and acquired knowledge of purification process development is a must have. Examples of relevant experience are resin screening, Design of Experiment (DOE) approach, viral inactivation/filtration, UF/DF development, etc. Experience of designing a process for highly concentrated solution is a plus
Experience in pilot-scale activities is a plus
Experience in purification process development of viral vectors is a plus
Experience with robotic platform (Tecan) and/or modelling (GoSilico) is a plus
Master’s degree (or equivalent relevant experience) in bioprocess/pharmaceutical sciences field
At least 8 years of hands-on experience in using chromatography and filtration equipment, > 10 years preferred
Communicate orally and in writing fluently in English
Knowledge of the Quality requirements (GLP/GMP) related to CMC development activities of biologics
Experience in regulatory interactions is a plus
Strong ability and passion to work in a collaborative manner

Don't forget to mention EuroPharmaJobs when applying.

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