Analytical Development Mass Spectrometry Analyst

Analytical Development Mass Spectrometry Analyst

DEMO Pharmaceuticals

Athens, Greece

Main duties and responsibilities

• Working with a team of scientists to conduct mass spectrometry experiments in support of biosimilar development programs;
• Perform the routine sample analysis to support the process development and optimization;
• Develop and qualify mass spectrometry methods for the characterization and quantification of biosimilar products, including peptide mapping, intact mass analysis, glycan analysis, and peptide sequencing;
• Excute the protocols and workflows to address specific analytical challenges related to biosimilar development, such as comparability studies, forced degradation studies, and stability testing;
• Stay current with developments in mass spectrometry technology and industry best practices, incorporating new methodologies and techniques as appropriate;
• Contribute to regulatory submissions by preparing technical documents, assay validation reports, and other supporting documentation in compliance with regulatory guidelines;
• Perform method qualification, optimization, and troubleshooting to ensure robustness, accuracy, and precision of analytical assays;
• Interpret mass spectrometry data and collaborate with bioanalytical and biophysical scientists to elucidate structural and functional attributes of biosimilar molecules.

Requirements

Experience, skills and qualifications required:

• B.Sc. or M.S. in Analytical Chemistry, Biochemistry, or related field with 1+ years of industry experience in mass spectrometry, preferably in a biopharmaceutical or biosimilar development setting;
• Knowhow in mass spectrometry techniques, including LC-MS, LC-MS/MS, and MALDI-TOF and data analysis software (e.g., MassLynx, Proteome Discoverer and etc…), with a focus on protein characterization and analysis;
• Strong problem-solving abilities and attention to detail;
• Understanding of protein chemistry, biophysical characterization techniques;
• Excellent communication skills;
• Experience in quality systems – GMP, GLP or Good Development Practices will be an advantage;
• Critical thinking & problem solving;
• Resilience and ability to work independently;
• Good communication and team player;
• Fast learner.