Analytical Project Lead
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 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 method development, stability indicating studies, method qualification and validation, method transfer, method monitoring and improvement
- Supporting all analytical activities to increase understanding of all properties of a molecule quality attribute assessment, defining the stability profile of the molecule and structure-function 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 other project related meetings representing all analytical aspects of the project
- Compiling documentation: product specifications, sampling plans, analytical method transfer protocols and reports, leachable and extractable studies
- Supporting preparation of reports of other departments (e.g. USP development, DSP development, manufacturing) by providing analytical data collected in analytical departments, both R&D and QC, and support interpretation of these data
- Supporting any troubleshooting activities with analytical knowledge
- Coordinating and performing analytical activities
- Presenting analytical topics related to the project during internal and external audits
- Supporting preparation of regulatory submissions as well as participation in meetings with regulatory authorities as needed
- Preparation, reviewing of procedures, protocols and reports
- Communication with external companies to align on analytical tasks
If you have:
- University degree (biotechnology, analytical chemistry, biochemistry, pharmacy, or related)
- Practical and theoretical knowledge about development, transfer and validation of analytical methods, stability studies, liquid chromatography concerning work with biological drugs (such as: peptide mapping, SEC, IEC, HILIC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopeial methods used for released raw materials, intermediates and final drug products
- 5 years’ experience in regulated laboratory environment (biotech lab preferably)
- Very good knowledge of GLP and GDP rules
- Project management experience
- Fluent English