Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Analytical Project Lead
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
1
Analytical Project Lead
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Be the single point of contact for all analytical topics within an project from development to product discontinuation. Coordinating analytical activities and compiling analytical documents to support the project
- Actively manage analytical knowledge of a certain project by communicating to all people involved in analytical activities and having an overview on these activities
- Oversee and coordinating method development, stability indicating studies, method qualification and validation, method transfer, method monitoring and improvement
- Support all analytical activities to increase understanding of all properties of a molecule like quality attribute assessment, defining the stability profile of the molecule, structure function relationships
- Oversee and coordinating specific analytical activities of a certain project like: comparability studies, establishment of analytical standards, cleaning validation of manufacturing units
- Participate in project team meetings and other project related meetings representing all analytical aspects of a certain project
- Compile documents like product specifications, sampling plans, analytical method transfer protocols and reports, leachable and extractable studies
- Support preparation of reports of other departments (e.g. USP development, DSP development, manufacturing) by providing analytical data collected in analytical departments both development and QC and support interpretation of these data
- Support any troubleshooting activities with analytical knowledge and coordinating and performing any analytical activities
- Present analytical topics of a certain project during internal and external audits
- Support preparation of regulatory submissions; participate in meetings with regulatory authorities as needed
- Prepare, review and approve the procedures, protocols and reports
- Communicate with any external companies to align on analytical tasks
What do we expect?
- Higher education with a specialization in the fields: 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 biologic drugs (such as: peptide mapping, SEC, IEC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopoeial methods used for release raw materials, intermediates and final drug products
- 5 years’ experience in regulated laboratory environment (preferred biotechnological lab). Very good knowledge of GLP and GDP rules
- Project management experience
- Fluent English
- Good knowledge of MS Office
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.