At DEMO SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, our new Biotechnology Center in Athens, Ag. Stefanos is now fully operational.
Biotechnology is transforming healthcare, and DEMO is at the forefront with cutting-edge research and innovation. As we continue to grow, we are looking for a high-caliber Analytical Development Senior Scientist Mass Spectrometry to join our team.
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
- Minimum 5 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, DSC, DLS
- Very good knowledge of software like: Biopharma finder/protein matrix/protein discover and Chromeleon, 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
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.