Analytical Development Scientist

The Analytical Development Scientist will contribute to the design, development, qualification, and transfer of analytical methods supporting the development, characterization and release of gene therapy products. The position requires close collaboration with Pre-Clinical, Process Development (USP, DSP), Quality Assurance teams and CDMO/CRO partners to establish robust analytical strategies throughout the product lifecycle. He/she will work under the supervision of the Analytical Development Manager in compliance with quality, health and safety procedures, budget and timelines.

Main Activities

• Design, develop, and qualify analytical methods for characterization, release, stability, and process monitoring. Ensure analytical methods remain fit for purpose throughout the product lifecycle;
• Evaluate and implement novel analytical technologies to improve product characterization and process understanding;
• Perform root-cause investigations and troubleshoot analytical challenges;
• Collaborate transversally to understand the needs and ensure that method developments are planned and conducted in a timely manner (timelines and milestones) with the highest quality standard, as well as providing scientific support;
• Write and review qualification/validation protocols, reports, and supporting documentation according to applicable regulatory and quality requirements (in English);
• Support technical transfer of analytical methods internally to Quality Control Team, and externally to CDMOs/CROs;
• Ensures scientific quality of work performed: analyze, interpret and present complex scientific data. Generate clear conclusions and recommendations to support decision‑making. Maintain accurate laboratory records and technical reports;
• Ensure activities comply with applicable quality systems and regulatory requirements;
• Contribute to deviations investigations, CAPAs, change controls, risk assessments, and continuous improvement initiatives and participate to internal audits;
• Participate in the general operation of the laboratory and ensure compliance with laboratory best practices (GxP).

Profile

• Educational background in biology biotechnology, biochemical engineering or related (MSc or PhD);
• A minimum of 5 years in the field of Gene Therapy (AAV vectors) and/or in the development, validation of analytical methods for biopharmaceutical products;
• Molecular biology (qPCR, RT-qPCR, ddPCR, ELISA, Western Blot) and cellular biology (Flow Cytometry, Bioassay and Potency assay);
• Strong scientific curiosity and critical thinking;
• Excellent problem‑solving and troubleshooting skills;
• Strong communication and technical writing abilities;
• Strong organizational skills and ability to work within a team and project group;
• Good notion of GLP, GMP and Quality management system (QMS);
• Good written and spoken French and English.