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Participation in the production of biotechnological products in accordance with GMP rules and FDA requirements in order to obtain a product of the quality set in the specification, for registration, preclinical research and implementation on pilot or production scale. Participation in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnological products.
- Documenting obtained results/process parameters in compliance with technological documentation and internal requirements.
- Participation in technology transfer.
- Preparation of reports and all documentation necessary to evaluate the process.
- Informing the immediate superior about any irregularities in the process, documentation, status of performed tasks and decisions taken.
- Taking operational decisions with the support of the Team Leader or the Area Manager.
- Coordination of activities related to the implementation of improvements in production.
- Participation in execution of the manufacturing process of biotechnological products in accordance with the technological documentation and in accordance with the principles of GMP and other internal requirements.
- Preparation of documentation in accordance with the principles of GMP and internal company requirements.
- Reporting the progress of all work and status of performed tasks to the immediate supervisor.
- Worthy representation of the company during external meetings.
- Support in preparation of reports on performed tasks.
- Securing the workplace.
- Organizing work in order to make the most effective use of working time and complete tasks.
- Cooperation with all teams of the Technical Operations Department and all other departments.
- Support in creation of Standard Operating Procedures and Instructions and conducting training on them.
- Participation in conducted qualifications.
- Creation of operating instructions for devices and conducting training on them.
- Training of less experienced coworkers.
- Higher education in biotechnology, pharmacy or related fields.
- Experience in research/development or production of biotechnology products or potential therapeutic molecules it will be a plus.
- Experience in working with recombinant proteins.
- Knowledge of the principles of good cGMP manufacturing practice.
- Experience in keeping process documentation in accordance with GMP rules (would be beneficial).
- Experienced in the use of biopharma (or lab scale) equipment (i.e. chromatographic systems/bioreactors etc.) and/or knowledge of related techniques.
- Good organization of work and time.
- English spoken and written.
- Knowledge of MS Office.
- Flexibility for new tasks, communication skills, ability to work in a team.
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.