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
