Analytical Development Mass Spectrometry Scientist

Analytical Development Mass Spectrometry Scientist

DEMO Pharmaceuticals

Athens, Greece

Main duties and responsibilities

• Conduct protein analysis with use of Mass Spectrometry based methods, e.g peptide mapping, disulphide bridges mapping, post translational modifications, intact mass profiling etc.; and chromatography methods:
  • Analytical methods development and qualification;
  • Data interpretation and reports writing;
  • Trouble shooting;
  • Regulatory documentation writing, review and editing;
  • Support of Process development by providing the analytical data;
  • Document writing such as SOP, Protocols and reports;
  • Analytical methods transfer to QC.
• Facilitate internal trainings to Bio-team colleagues;
• Contribute to development projects by:
  • Follow and implement EU and US regulations regarding all aspects related to the quality and analytical characterisation of biological medicinal products with an emphasis on biosimilars development;
  • Setup and maintenance of the analytical infrastructure required for AD with emphasis to Mass Spectrometry.
• Collaboration with Quality Assurance dept. to set up and supervision the quality system required to run Analytical Development and QC depts.

Requirements

Experience, skills and qualifications required:

• Bachelor’s Degree in Biology, Biotechnology, Chemistry or related with post graduate studies (MSc/PhD) in a field related to biotechnology, biochemistry or molecular biology
• 1-3 years of experience in biotech/biosimilar or pharmaceutical company in the field of biotech;
• Good understanding of regulations required for analytical development of biotech products, preferably in biosimilars development;
• Working experience in method development and validation of common pharmaceutical analytical techniques such as : Mass Spectrometers, UPLC, FTIR, CD, Capillary Electrophoresis;
• Very good knowledge of software like: Empower, Data visualization and statistics like: Graph Pad Prism, JASP, JMP or similar;
• Working experience in analytical techniques for protein analysis regarding their physical-chemical structure with emphasis to mass spectrometry and chromatography
• Strong problem solving attitude, critical thinking;
• Resilience & ability to work independently;
• Excellent communication skills both verbal and written;
• Team player & fast learners.