Quality Control Senior Analyst - Bioassays & Molecular Assays, Biotechnology Ops
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 Quality Control Senior Analyst – Bioassays & Molecular Assays to join our team.
Main Duties and Responsibilities
- Transfer and validate analytical methods for biosimilar products, including potency assays, cell-based assays, DNA content analysis, and ELISA.
- Perform release and stability testing, as well as in-process control of biosimilar products.
- Contribute to the development and revision of SOPs related to analytical instrumentation and laboratory processes.
- Analyze data, interpret results, draft reports, and provide scientific insights to support decision-making in collaboration with cross-functional teams.
- Stay up to date with advancements in technology and industry best practices, incorporating new methodologies where appropriate.
- Contribute to regulatory submissions by preparing technical documentation, including assay validation reports, in compliance with applicable regulatory requirements.
- Ensure compliance with EU and US regulations related to the quality of biological medicinal products.
- Act as a trainer for new hires and support knowledge transfer within the team.
Requirements
- MSc in Biology, Biotechnology, Biochemistry, or a related field.
- PhD in Biotechnology, Biochemistry, Molecular Biology, or a related field will be considered an asset.
- Hands-on experience in cell culture and analytical techniques for protein characterization, including ELISA, molecular biology techniques (e.g., qPCR), and cell-based assays.
- Proven industry experience in the analysis of biotechnological products.
- Familiarity with regulatory requirements for biopharmaceutical characterization, including ICH guidelines, and FDA/EMA regulations.
- Excellent written and verbal communication skills in English.
- Strong problem-solving skills and critical thinking mindset.
- High adaptability in dynamic and evolving laboratory environments.
- Strong laboratory setup and organizational skills.
- Ability to work independently with resilience and accountability.
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
Skills Required
- MSc in Biology, Biotechnology, Biochemistry, or a related field
- Hands-on experience in analytical techniques for protein characterization
- Familiarity with regulatory requirements for biopharmaceutical characterization
- Excellent written and verbal communication skills in English
- Strong problem-solving skills and critical thinking mindset
- High adaptability in dynamic and evolving laboratory environments
What We Do
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products. The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe. Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology. At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece. DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone. Learn more at www.demo.gr
