Quality Control Senior Analyst - Bioassays & Molecular Assays, Biotechnolog at Demo S.A.

Athens, Attica, Greece -

Full Time

Start Date

Immediate

Expiry Date

17 Aug, 26

Salary

0.0

Posted On

19 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Validation, Potency Assays, Cell-Based Assays, DNA Content Analysis, ELISA, qPCR, Protein Characterization, Cell Culture, SOP Development, Regulatory Compliance, Technical Documentation, Data Analysis, Problem Solving, Critical Thinking, Laboratory Organization, English Communication

Industry

Pharmaceutical Manufacturing

Description

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

Responsibilities

The role involves transferring and validating analytical methods for biosimilar products and performing release, stability, and in-process control testing. Additionally, the analyst will develop SOPs, prepare technical documentation for regulatory submissions, and train new hires.