Planning and execution of laboratory scale studies for the purpose of development and optimization of protein purification steps, including chromatography, filtration and membrane separations
Documented observations, analyzes of data, reporting of results and conclusions for each experimental study
Troubleshooting activities and deviations’ assessment
Assessing improvements in DSP setup
Optimization of the process with regards to technical as well as its economic aspects
Evaluation of external suppliers of resins, filter membranes, disposable materials etc.
Supporting GMP manufacturing through process investigations and during process transfer
Design and execution of experiments based on DoE approach
Collaboration with USP, Analytical and Pilot Plant departments in order to achieve optimal results
Supporting and coordinating work of junior team members in their assigned tasks
If you have:
University degree in Biotechnology or related disciplines
2+ years of experience in purification process development (preferably antibodies) in the industry is highly desirable, however the candidates with strong experience and demonstrated track record in the development and optimization of protein purifications in university/academia will also be considered
Knowledge of fundamentals of protein expression systems and upstream process development
Experience in working with quality and process documentation
Experience with TFF and normal-flow filtration
Strong understanding of protein chromatography
Proven ability to work independently in the hands-on laboratory setting
Experience in handling lab-scale chromatography systems (such as ÄKTA systems) is required
Analytical skills and knowledge of spectrophotometric methods is desired
Experience with writing technical development or scientific reports/publications
Tech transfer & scale-up experience from R&D to cGMP environment is a plus
Basic knowledge of GMP standards is a plus
Fluent English
Capacity of writing protocols, instructions, and reports English
