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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.
- Carry-out and monitoring of biotechnological production processes according to technological documentation, GMP rules and internal quality requirements in scope of downstream processes – purification, filtration and formulation during drug substance manufacturing
- Analysis of achieved process data according to compliance with technological documentation and internal requirements
- Participation in technology transfer and process validation in cooperation with Research and Development Department and MS&T
- Preparation of documentation according to GMP rules and Company internal requirements
- Preparation of Standard Operational Procedures and instructions
- Guarantee of effective production activities preparation and carry out, responsibility for production process continuity, reporting of performed actions statuses
- Supervision of proper raw materials expenditure during technology transfer and production processes.
- Shift work
- Higher education (at least Msc) in Biotechnology, Pharmacy or similar
- At least two year experience in biotechnological or pharmaceutical industry
- Good knowledge of cGMP and FDA requirements
- Experience in keeping records in production documentation according to GMP requirements
- Chromatography technics as affinity chromatography and ion exchange chromatography (CEX and AEX) is required
- Knowledge of filtration techniques (like tangential flow filtration - TFF) will be an additional advantage
- 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
- Very good speaking and writing English skills
- Knowledge of MS Office
- Good work organization and individual problem solving skills are required
- Good communication, team cooperation skills and being open for new tasks is required
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.