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Conducting activities related to the development, qualification and/or validation of new analytical methods or related to modification of existing methods for pharmacologically active biological particles and for medicinal products using them for registration, preclinical studies and implementation in the technical scale runs. Prepares documentation of research results for the purposes of registering medicinal products under development. Cares for the application of EHS and ALCOA principles in the Laboratory of Technical Research and Development - Polpharma Biologics Warsaw.
- Conducting research related to the development of new and modification of existing analytical methods for control of active substances (pharmacologically active biological particles) and biotechnological medicinal products.
- Conducting analytical method qualification and method transfer to Quality Control section or other external company.
- Performing tests of analytical control of the substances and the drug form during its development and during technical batch runs.
- Analyzing and interpreting the results of research carried out during development and during technical batch runs.
- Keeping records of the carried out research, transfer and/or qualification/validation of methods in accordance with existing standard operating procedures and the principles.
- Developing standard operating procedures and instructions and conducting the training on them.
- Perform maintenance, calibration and qualification of physicochemical equipment in accordance with the instructions and procedures.
- Reviewing the specialist literature in order to select the appropriate analytical control methods for new substances and biotechnology drug form.
- Controlling the usage and preparation of purchasing requests for direct and supporting materials as well as substances and reagents used during the research.
- Supporting activities related to the creation of Analytical Development laboratory with the use of good laboratory practices as well as organizational and safety standards
- Writing User Specification Requirements (URS) and participation in the equipment purchase process
- Supporting the work of team members in the preparation of documents such as SOP, protocols and reports, and other laboratory tasks.
- Providing technical and scientific support for laboratory analytical methods.
- Carrying out activities aimed at ensuring the functioning of the laboratory in accordance with the principles of health and safety, hygiene, environmental protection and 6S.
- Higher education in the field of: biotechnology, biology, biochemistry or related.Min.0-2 years of experience in laboratory work (analytical or quality control laboratory) in biotechnological or pharmaceutical company
- Knowledge of analytical techniques such as: ELISA, Cell culture, Microplate reader, microscope, FACS, Cell banking, Immunoassays, PLA software.
- Knowledge of topics related to GxP
- Experience in writing procedures, protocols and reports.
- The ability to think creatively and the ability to collaborate with others to solve technical problems.
- Good organization of work and time
- Knowledge of MS Office
- Very good command of spoken and written English.
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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.