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As a member of our Technical Operations department you will participate in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in manufacturing of biotechnology products in accordance with GMP principles and FDA requirements.
- Participation in the production of biotechnological products in accordance with GMP rules and FDA requirements
- Participation in purification of therapeutic proteins from microbial cells, Column Packing & Bottling, buffer preparation;
- Participation in technology transfer, process characteristics and process validation
- Analyzing the obtained process results in terms of compliance with technical documentation
- Supporting of production team in aim of effective resources utilization, conducting the trainings;
- Close cooperation with the MS&T, Production Operational Department and Quality Department;
- Participation in investigation for quality deviations and implementation of CAPA.
- Higher education in Biotechnology, Biochemistry, Chemistry or similar
- Hands-on experience with purification unit operations including filtration, chromatography, UF/DF, AKTA systems and UNICORN software
- At least two year experience in biotechnological or pharmaceutical industry
- Chromatography technics as affinity chromatography – protein L and ion exchange chromatography (CEX)
- Knowledge of filtration techniques (like tangential flow filtration - TFF)
- Knowledge of aseptic techniques will be an additional advantage
- Experience in work with recombinant proteins will be an additional advantage
- Experience in single use materials usage for biopharmaceutical production will be an additional advantage
- Good knowledge of cGMP and FDA requirements
- Very good speaking and writing English skills
- Good work organization and troubleshooting
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Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.