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Main responsibility will be to design, develop, qualify/validate and execute various LCMS methods to characterize and assess the structural, purity, heterogenicity and PTMs of biopharmaceuticals for different products to support process development activities within Technical Research and Development department. In addition to instrument operation, the LCMS 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 methods related to LCMS.
- Development, validation, and execution of LC methods, including HPLC, UPLC, LC-MS as well as other instrumental techniques.
- Leading the introduction and expansion of LC-MS as a new service offering within the department
- Developing LC-MS / MS based methods to characterize and assess the structural, purity, heterogenicity and PTMs of different biologics (mAbs )
- Mass spectrometer (Xevo G2-XS QTof Quadrupole Time-of-Flight Mass Spectrometry) calibration, tuning, and optimization.
- Routine LC/MS analysis (characterization, qualification, sample analysis, etc).
- Chromatographic peak integration (including post-acquisition processing of high resolution MS data).
- Performing basic LC/MS instrument maintenance, troubleshooting, and repair skills.
- Assist project managers with method troubleshooting through data interpretation, experimental design, and data collection.
- Executing validation/transfers/optimization of test methods as per appropriate protocols.
- Supervising work of assistants, technicians, junior specialists and specialists within assigned task.
- Evaluating of external companies’ documentation within scope of collaboration (method development, qualification and transfer, samples analysis).
- Supervising over general laboratory maintenance duties if required and over accommodation of analytical laboratory to requirements of inspection authorities (internal and external).
- PhD in analytical chemistry, biochemistry or related discipline with LC-MS. Industry experience is plus.
- Proven experience in mass spectrometry and chromatographic techniques for the analysis of proteins, oligonucleotides and peptides.
- Hands on experience in LC-MS instruments( Xevo G2-XS QTof Quadrupole Time-of-Flight Mass Spectrometry), method development and validation for characterization of different mAbs,.
- Hands on experience on MS data analysis software and data interpretation.
- Experience managing and training junior staff and individual contributors.
- 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.
Poznaj
Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.