Quality Control Senior Analyst - Bioassays & Molecular Assays, Biotechnology Ops

DEMO Pharmaceuticals

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.