• With a Quality by Design (Qb D) 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 (Go Silico) 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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