Quality Control Bioassay Specialist
Gdańsk
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 include, but are not limited to:
- Conducting biological analyzes using the following methods: ELISA, qPCR, in vitro using cell cultures etc. in accordance with the applicable analytical methods.
- Acting as SME for analytical methods.
- Development and reporting of the results of biological analyzes.
- Verifying the results of biological analyzes performed by other analysts, obtained in Polpharma Biologics and the results provided by external companies.
- Conducting the process of validation and qualification of analytical biological methods.
- Carrying out the process of transferring biological methods to and from external companies and within the organization.
- Creation and updating of analytical methods in the field of QC Bioassay.
- Supporting the process of creating Certificates of Analysis.
- Direct participation in audits and business visits.
- Acting as owner responsible for Quality systems including Change Control and CAPA activities.
- Managing the quality documentation of the Biological Quality Control team.
- Performing and Supervising Data Integrity compliance activities.
- Supervising the training status and supporting the team in the implementation of training and courses.
- Conducting trainings for other team members.
- Performing oversight of processes related to instruments, technical software qualifications and data integrity.
- Cooperation with other departments of Polpharma Biologics.
- Fulfilling the obligations in accordance with the current GMP regulation and other pharmaceutical guidelines.
- Taking care of the laboratory and its contents and keeping it ready for routine activities and audit visits.
- Performing other activities ordered by the supervisor.
If you have:
- Higher education in the field of biology, chemistry, pharmacy, biotechnology.
- Minimum 3 years of experience in laboratory work in regulated laboratory environment.
- Very good knowledge of GLP, GMP and GDP rules.
- Ability to independently solve problems and work in a team.
- Very good knowledge of English language.
- Laboratory precision.
- Analytical thinking.
- Good organization of work and time.
- Very good ability to collaborate with others to solve problems.
- Timeliness, the ability to prioritize tasks.
- Very good knowledge of MS Office.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more..
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.