Cell Culture DSP Plant Specialist
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities
- 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 is required
If you have
- 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