Analytical Development Bioassay Senior Scientist
3 days ago
At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, our new Biotechnology Center in Athens, Agios 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 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.
Requirements
- MSc in Biology, Biotechnology, Biochemistry or related field
- PhD in a field related to Biology, Biotechnology, Biochemistry, Molecular Biology is considered an asset.
- More than 4 years industry experience in monoclonal antibodies, and experience in biosimilars.
- 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.
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
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