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Improving and optimizing production processes by proposing changes and implementing solutions in cooperation with the MS&T department and other plants of the Polpharma Biologics group. Participation in technology transfer in accordance with cGMP regulations and internal SOPs during the implementation of projects related to the introduction of new biotechnology products. Participation in process validation. Participation in manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification.
- Substantive supervision and monitoring of the production process of biotechnological products in accordance with the principles of GMP, technological documentation and other internal requirements;
- Planning and initiating activities regarding production processes optimization;
- Creating guidelines and recommendations for other Teams of the Production Department;
- Substantive supervision and monitoring of the technological trials in accordance with the principles of GMP, technological documentation and other internal requirements
- Participation in the technology transfer in terms of implemented manufacturing processes of active substance in the production area;
- Participation in the elaboration of pre-validation/validation strategy in alignment with process validation lead, including supportive studies;
- Participation in monitoring and continuous verification of the active substance manufacturing process;
- Review key documents & coordinate input for relevant registration documents for accuracy & completeness (as appropriate);
- Documentation preparation according GMP rules and internal company requirements;
- Acting as the owner of technical change in accordance with GMP change management processes for a new and / or improved product, equipment and process through implementation, validation in a GMP environment.
- Participation in investigation for quality deviations and implementation of CAPA
- Development and verification of design documentation and equipment qualification documentation;
- Participation in the qualification of equipment and systems;
- Elaboration of SOPs and manuals (including manuals to equipment);
- Close cooperation with the MSAT, Production Operational Department and Quality Department;
- Cooperation with all Production Department team and other groups from site and Polpharma;
- Work organizing and impact on the work of others in order to make the most effective use of working time and performance of tasks.
- Higher education in the field of: biotechnology, biology, biochemistry or related;
- 5 years of professional experience;
- Knowledge of Upstream or Downstream process,
- Experience in process validation;
- Experience in keeping process and design documentation;
- Experience in equipment qualification processes in pharmaceutical companies;
- Good knowledge of EudraLex GMP and FDA requirements for bilogical and strile products;
- Very good command of spoken and written English;
- Good skills of work and time organization, problem solving, good communication and team cooperation.
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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.