Analytical Development Bioassay Senior Scientist
501-2000
Pharmaceutical & Health sector
22 days ago
Posted date22 days ago
Science / ResearchJob category
Science / ResearchAt 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.
Requirements
- 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.
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.