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 role:
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.
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
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