Analytical Development Bioassay Senior Scientist

At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are excited to kick-off our Biotechnology project in Athens.

• Demo leads the way in the Greek pharmaceutical market with major investments in Biotechnology;
• We are building a prototype unit for the development of monoclonal antibodies.
• We are creating a contemporary Research and Development Center for biotechnology.

As a result, we are currently looking for a Bioassay Senior Scientist in our Analytical Development team.

Main duties and responsibilities:

• Develop and qualify methods for the characterization and quantification of biosimilar products, including potency, cell-based assays, DNA content, ELISA and SPR.
• Design experimental protocols and workflows to address specific analytical challenges related to biosimilar development, such as comparability studies, forced degradation studies, and stability testing.
• Analyse data, interpret results, and provide scientific insights to guide decision-making in collaboration with cross-functional teams.
• Stay current with developments in advance 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 data and collaborate with mass spectrometry and biophysical scientists to elucidate structural and functional attributes of biosimilar molecules.

• MSc in Biology, Biotechnology, Biochemistry or related field
• PhD in a field related to Biology, Biotechnology, Biochemistry, Molecular Biology is considered an asset.
• Industry experience in monoclonal antibodies. Experience in biosimilars is considered an asset.
• Strong expertise in analytical techniques for protein analysis regarding their biological properties e.g. ELISA, Molecular biology techniques, cell-based assays, SPR, Q-PCR etc with a focus on protein characterization and analysis.
• Demonstrated ability to design and execute complex experiments, analyze data, and communicate results effectively to diverse stakeholders.
• Familiarity with regulatory requirements for biopharmaceutical characterization, including ICH guidelines, FDA/EMA regulations, and industry standards.
• Excellent written and verbal communication skills, with the ability to collaborate effectively in a cross-functional team environment.
• Strong problem-solving abilities and attention to detail, with a commitment to delivering high-quality results on time and within budget.
• Software knowledge like: excel, Data visualisation and statistics like: Graph Pad Prism, JASP, JMP or similar.
• Experience in quality system – GMP, GLP or Good Development Practices will be advantage.
• Excellent communication skills both verbal and written in English.
• Strong problem-solving attitude, critical thinking
• Resilience & ability to work independently.

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.