Downstream Process Development Scientist
Ferring Pharmaceuticals
Lausanne, Switzerland
Your day at Ferring
- 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
Behind our innovation…There’s you
- 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
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