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Main responsibility will be to design, develop, qualify and execute various SPR (Biacore) assays to characterize and assess the binding and kinetics of biopharmaceuticals for different products (mAbs) to support process development activities within Technical Research and Development department. In addition to instrument operation, the SPR senior specialist is responsible for associated maintenance, documentation, and data processing in a manner which meets company objectives and timelines.
In this position, you will work with 1-3 laboratory junior specialist/specialist and you will be designing and developing a range of FcγR and Fab related binding assays and kinetics.
- Directly accountable for development and qualification of protein: protein/protein: ligand interaction kinetics using label-free methods specifically SPR (Biacore) with strong focus on mAbs.
- Responsible for experimental design, execution, data review and analysis, document writing, and contributing to sections of regulatory submissions.
- Maintain and enhance instrumentation and workflows for measuring protein-protein binding interactions.
- Supervising work of assistants, technicians, junior specialists and specialists within assigned task.
- Evaluating of external companies’ documentation within scope of collaboration (method development, qualification, samples analysis).
- Supervising over general laboratory maintenance duties if required and over accommodation of analytical laboratory to requirements of inspection authorities (internal and external).
- Contribute to evaluation, and develop and implement new technologies.
- Maintain controls, reagents and reference standards to support testing.
- Review/approve data generated by other team members.
- Train others.
- Review SPR analytics documents to ensure completeness, accuracy, consistency and clarity.
- Generate/revise protocols/reports, SOPs and other documentation.
- Contribute to evaluation, and develop and implement new technologies.
- Strict compliance with safety rules.
- PhD or experienced BS/MS level with 5+ years’ experience with Surface Plasmon Resonance (SPR) or similar instrumentation.
- Demonstrated expertise in method development and data analysis for measuring binding kinetics.
- Deep expertise and scientific understanding of biosensors, including practical experience running and maintaining state of the art instrumentation such as Octet, Biacore, and/or Carterra.
- Expertise in biophysical characterization and developability of proteins.
- Experience working in drug development and interfacing with colleagues with disparate scientific backgrounds.
- knowledge of regulations and guidelines for good laboratory practice (GLP) and Good Manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines.
- Fluent English spoken and written.
- Fluent MS Office skills.
- Good organizational skills.
- Ability to cooperate with others in order to solve problems.
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.