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In this role you will function as a single point of contact for all analytical topics within assigned project, from development to production discontinuation. You will be tasked with coordination of analytical activities and compilation of analytical documentation. You will be responsible for active management of analytical knowledge about the specific project, through communication with all peoples involved in analytical activities and verification of these activities. You will also support problem solving processes that need to be based on extensive analytical knowledge.
- Supervising and coordinating the development of analytical methods, research on sample and product stability, qualifications, validations, and transfers of analytical methods as well as their monitoring and improvement
- Supporting all analytical activities needed for the purpose of better understanding of properties of large molecules (i.e. assessing quality attributes, defining stability profile of a molecule, and structures-functions relations)
- Supervising and coordinating specific analytical activities within a particular project, e.g. comparability studies, establishing analytical standards, validation of cleaning of production units
- Attendance at project team meetings and other project-related meetings that represent all analytical aspects of a particular project
- Compilation of documents, such as product specifications, sampling plans, protocols, and reports related to transfers of analytical methods.
- Supporting preparation of reports of other departments (e.g. USP development, DSP development, production) by providing analytical data collected in analytical departments in both development and quality control, and support for the interpretation of these data
- Presenting analytical topics related to a specific project during internal and external audits
- Supporting the preparation of regulatory proposals and, if necessary, participation in meetings with regulatory authorities
- Communication and cooperation with external companies to align on analytical tasks
- Participation in weekly meetings regarding transfers of analytical methods, cyclical project meetings with the project management team
- Tracking the status and coordination of analytical methods’ transfers (between R&D and QC, between Polpharma Biologics and external companies)
- Creating documents such as specifications, files containing a summary of analytical methods, sampling plan and procedures for in-process controls
- University degree 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 biological drugs (such as: peptide mapping, SEC, IEC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopeial methods used for release of raw materials, intermediates and final drug product
- Minimum 5 years of experience in regulated laboratory environment (biotech lab preferably)
- Very good knowledge of GMP, GLP and GDP rules and regulations
- Project management experience
- Fluent English
- Very good knowledge of MS Office
- Teamwork and problem-solving skills
- Tasks’ prioritization skills according to timelines
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.