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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 a semi-technical 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.
- Analyzing the obtained process results in terms of compliance with technological documentation and internal requirements.
- Participation in technology transfer, process characteristics and process validation in cooperation with the Research and Development Department and Manufacturing & Science Technology MS&T Department.
- Ongoing provision of reports and all necessary documentation to the supervisor and/or appropriate persons to evaluate the process.
- Informing the immediate supervisor about any irregularities and potential delays in the process, documentation, as well as the status of the tasks performed and decisions taken.
- Monitoring the process of manufacturing biotechnological products in accordance with the technological documentation.
- Carrying out the process 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.
- Representing the company well.
- 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.
- Developing model procedures and instructions and conducting training on them.
- Preparation of equipment qualification documentation, conducting qualifications and/or participation in conducted qualifications.
- Development of operating instructions for devices and conducting training on them.
- Following the supervisor's orders.
- Specialization: completed studies in biotechnology, pharmacy or related fields.
- Experience in research/development or production of biotechnology products or potential therapeutic molecules.
- Good knowledge of the principles of good cGMP manufacturing practice.
- Experience in keeping process documentation in accordance with GMP rules.
- Very good knowledge of aseptic work techniques, especially in conducting bacterial cultures.
- The ability to independently solve problems, good organization of work and time.
- Very good command of spoken and written English; knowledge of MS Office.
- Flexibility for new tasks, communication skills, ability to work in a team.
- Experience in the use of stainless steel installations and disposable materials for the production of biotechnological drugs is an additional advantage
- Experience in working with recombinant proteins will be an advantage
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.