Analytical Process Development 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:
- Independently conduct work related to the development, qualification, and validation of new analytical methods or modification of existing methods for pharmacologically active biological molecules and drug product for registration, preclinical studies, and semi-technical scale implementation.
- Conducting studies of extended characterization of new forms of biotechnology drugs in terms of biology and/or physiochemistry.
- Collaborate and communicate with other company departments as well as with external partners in the analytical methods under development.
If you have:
- University degree in biology, biotechnology, chemistry, biochemistry, molecular biology, or pharmaceuticals.
- Minimum 3 years of experience working in an analytical laboratory (experience in the pharmaceutical industry is welcome).
- Experience in working with proteins, in particular with monoclonal antibodies, very good knowledge of biochemistry and analytical methods.
- Working knowledge of advanced analytical techniques (ion exchange chromatography, affinity, hydrophobic, reversed-phase and normal-phase interaction, electrophoretic and spectroscopic techniques, ELISA, blotting, PCR, cell-based assays and related cell cultures), planning, development, optimization, qualification and validation of analytical methods.
- Working knowledge of analytical instrument software; experience with Empower/Gen 5/JMP/PLA software would be an asset.
- Fundamental knowledge of GLP and GMP regulations, EMA and FDA guidelines for analysis of biotechnology products, including biosimilars.
- Ability to analyze specialized literature.
- Very good knowledge of English language allowing for free communication and preparation of documentation.
- Good organization of own work and ability to work in a team.
- Ability to think analytically and goal-oriented.