Production Process Trainer
Duchnice
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 responsibilities
- Defining and developing training needs, conducting trainings in on-line form and stationary training regarding GMP rules for Production Department employees;
- Establishing and developing training documentation for Production Department employees. Maintaining the training documentation in accordance with GMP;
- Supporting assessment of employee readiness for independent work in manufacturing area;
- Elaboration of SOPs and instructions and training from them;
- Documentation preparation according GMP rules and internal company requirements.
- Monitoring the manufacturing process of biotechnology product accorrding to GMP requirements, technological documentation and other internal requirements.;
- Supporting of production team in aim of effective resources utilization, conducting the trainings;
- Conducting the training for employees of the Production Department in the scope of GMP, qualification activities and DI;
- Participation in investigation for quality deviations and implementation of CAPA.
If you have
- Higher education in Biotechnology, Biology, Chemistry or similar (life/natural sciences);
- Minimum 2 years of experience in a similar position;
- Good knowledge of EudraLex GMP and FDA requirements for biological and sterile products;
- Experience in working with recombinant proteins and their purification. Additional advantage will be performing monoclonal antibody purification process in production scale according to GMP rules;
- Experience in working with manufacturing documentation;
- Good knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage;
- Very good speaking and writing English skills (level B2);
- Coaching competencies;
- Good work organization, problem solving, very good 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.