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 role
In this position you will act as a Quality Control Bioassay Specialist in the QC Bioassay Team. You will be responsible for performing and reporting the results of biological analyzes in accordance with applicable procedures and guidelines.
Your responsibilities
- Conducting biological analyzes using the following methods: ELISA, qPCR, in vitro with the use of cell cultures, etc. in accordance with applicable documentation
- Preparation and review of protocols, reports, instructions, test methods, procedures, and other documents in the Department of Biological Quality Control
- Planning and execution of validation and transfer of analytical methods along with the preparation of all related documentation
- Checking and verification of the analytical results and validation and transfer documentation, in accordance with the applicable procedures
- Development of Standard Operating Procedures, Instructions and Analytical Methods and conducting trainings on them
- Close cooperation and communication with other teams at Polpharma Biologics
- Performing maintenance, calibration, and qualification of laboratory equipment in accordance with applicable instructions and procedures
- Supervising the work of lab technicians as part of the assigned tasks
- Performing standard activities related to work in the laboratory, i.e. preparation of reagents, waste management (including hazardous waste), keeping records of consumables and reagents and their replenishment
- Writing and checking of the certificates of analyses for the results obtained in Polpharma Biologics and in cooperation with external companies
- Participation in trainings designated by the supervisor and training of co-workers
- Performing tasks other than those listed above at the request of the supervisor
If you have
- University degree in the field of microbiology, biotechnology, biology, chemistry or related
- Minimum 3 years of experience in laboratory work in a regulated environment (preferably in a biotech lab and/or pharmaceutical industry)
- Very good knowledge of GLP, GMP and GDP rules
- Ability to independently solve problems and work in a team
- Fluent English
- Laboratory precision
- Analytical thinking
- Good organization of work
- Very good ability to collaborate with others to solve problems
- Ability to prioritize tasks, according to timelines
- Very good knowledge of MS Office