QC Analytical Projects Lead
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!
Role:
In this position you will be responsible for project management and you will be the single point of contact for all analytical topics within the project – from development to product discontinuation.
Your responsibilities
- Coordination of analytical activities and compilation of analytical documentation to support the project
- Actively managing analytical knowledge of the project by communicating to all people involved in analytical activities and having an overview on these activities
- Overseeing and coordinating methods development stability indicating studies, methods qualification and validation, method transfer, method monitoring and improvement
- Supporting all analytical activities to increase understanding of all properties of molecules quality attributes assessment, defining the stability profile of the molecules and structures functions relationships
- Overseeing and coordinating specific analytical activities of a certain project i.e. comparability studies establishment of analytical standards
- Participating in project team meetings and others project related meetings representing all analytical aspect of the project
- Supporting preparation of reports of other departments (e.g. USP development, DSP development manufacturing by providing analytical data collected in analytical department both TR&D and QC and interpretation of this data
- Supporting and troubleshooting activities with analytical knowledge
- Coordinating and performing analytical activities
- Preparation, reviewing of procedures, protocols, and reports
- Communication with external companies to align on analytical tasks
If you have
- University degree with a specialization in the fields: biotechnology, chemistry, biochemistry, pharmacy or relevant
- Practical and theoretical knowledge about developing, transfer and validation of analytical method, stability studies, chemical or biological method concerning work with biological drugs (such as peptide mapping, SEC, IEC, HILIC, capillary electrophoresis, ELISA, qPCR, UV-VIS spectrophotometry), pharmacopeial methods used for released intermediates and final drug products
- 5 years’ experience in regulated laboratory environment (biotech laboratory preferably)
- very good knowledge of GLP and GMP rules
- Project management experience
- Fluent English