- Design experiments, qualification, and validation strategy according to scientific and regulatory standards.
- Autonomously organize and carry out the development, qualification, and validation of analytical methods for the characterization and quality control of investigational products.
- Ensure scientific assistance to laboratory technicians in order to solve analytical issues on techniques run in the laboratory.
- Participate in the identification of analytical methods and contribute to implementation of new technologies where appropriate.
- Participate in the revision, validation and approval of analytical results and documentation (procedures, protocols, reports).
- Carry out technological and regulatory surveillance (EMA, FDA, ICH).
- Provide analytical expertise to projects.
- Project management (timelines, results, budget) and present/discuss results in project team meetings.
- Interact with QA and RA teams for file preparation and submission.
- Master’s degree or PhD in relevant scientific discipline (e.g. Medical Science, Life Science Biochemistry)
- At least 5 years of experience in the bio/pharmaceutical industry and/or GxP regulated laboratory is required.
- Strong expertise in ATMPs analytical method development and validation is a plus.
- Expertise in key analytical techniques for Biologics: immunoassays, bioassays, and QPCR is a plus.
- Understanding of QbD principles applied to method development is a plus.
- Strong and proven laboratory skills. High level of analytical troubleshooting needed for laboratory issues.
- Knowledge of GLP, GMP and ICH standards.
- Ability to handle multiple priorities, provide leadership and organization.
- Rigorous, perseverant, proactive and following to the end every subject.
- Excellent organizational and communication skills with the team and with external partners.
- Fluent in French and English
- A full-time permanent position (40h/week) in a growing team.
- To work in a human-sized, dynamic, respectful and professional environment.
- The opportunity to take part in a challenging scientific and business growth.
- An attractive salary package in line with the position responsibilities and your experience.