Physicochemical Quality Control 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
In this role, as a member of our growing Quality Control Phys-Chem team, you will be responsible for conducting physico-chemical analyses of products and raw materials. This position is an opportunity for you to become a valuable expert in the biopharmaceutical industry.
Your responsibilities
- Performing transfer and validation of physicochemical methods;
- Performing qualitative and quantitative physicochemical tests in tested products and starting materials;
- Verification of the correctness of test documentation in accordance with applicable procedures;
- Collection and registration of clean media, raw materials, semi-finished products, products ready for analytical testing
- Participation in the development of the GMP system in the Quality Control Laboratory
- Participation in investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality
- Participation in the preparation of the Quality Control area for GMP audits and certification
- Performing maintenance, calibration and qualification of laboratory equipment in accordance with applicable instructions and procedures
If you have
- Higher education, with a specialization in the fields: chemistry, biotechnology, biochemistry or related
- Experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech industry (at least 3 years)
- Experience in working with instrumental analytical techniques in the field of physicochemical tests of biotechnological drugs and/or raw materials, including such as: chromatography (HPLC, UPLC, GC), UV/VIS spectrophotometry, FT-IR, capillary electrophoresis
- Practical and theoretical knowledge in the field of validation and transfer of analytical methods
- Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines
- Experience in testing of biotechnological products (highly preferable)
- Minimum basic knowledge of statistical techniques
- Knowledge of MS Office pack
- Fluent English spoken and written
- Organizational and self solving problems skills
- Strong communication skills
Poznaj
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.