Analytical Project Lead

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Analytical Project Lead

Ogłoszenie wygasło

Pracodawca: Polpharma Biologics Group Numer referencyjny: 86178 Data publikacji: 17 sierpnia 2022 Lokalizacja: Gdańsk - Pomorskie Rodzaj umowy: - Doświadczenie: 1-3 lata Branże:
Przemysł i inżynieria: Chemia, chemia fizyczna, fizyka
Środowisko naturalne, bioróżnorodność: Badania naukowe

Opis stanowiska

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

Wymagania

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