The company is a leader in the management of clinical trials since 1998. Covering Europe (France, Belgium, Germany and Spain), MENA (Tunisia, Lebanon) and North America (Canada) with more than 300 employees, the company is one of the leading mid-size CROs in Europe. Their positioning in the market is unique:
• They cover all the technical range of services for clinical research: Regulatory Affairs, Clinical Operations, Biometrics, Pharmacovigilance, Medical Writing, Quality Assurance.
• They benefit from the expertise of the mother company to propose innovative solutions and IT tools.
• They manage their projects with a fully integrated QA system, based on KPI and risk management tools.
The company offers four business lines to meet all the clinical development needs:
• Project Development Services: An international CRO with expertise covering all stages of development (pre-clinical to Phase I to IV).
• Functional Services Provider: Near shore and offshore service centers, a tailor-made offer according to projects.
• Consulting: Covering worldwide needs from their main sites in France, Belgium, Canada and Lebanon.
• Real World Evidence: Providing the full set of services for real-life data collection and analysis.
As an analytical development scientist, you will join a team on client's site to provide in the support of internal and external partners with fit-for-purpose analytical methods for all phases of development of recombinant proteins. The main analytical techniques used in the laboratory are chromatography, electrophoresis and immunoassays.
Role and main tasks:
• Design experiments.
• Perform daily laboratory activities related to method development, validation and transfers.
• Contribute to release and stability testing related to the project as appropriate.
• Prepare documentation (procedures, protocols, reports).
• Analyze results.
• Verify data.
• Present/discuss results in project team meetings.
All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product.
• University degree in biochemistry or in analytical chemistry
• Proven experience in a similar mission preferably in the Biotech industry.
• Expertise in analytical chromatographic techniques applied to proteins.
• Expertise in other separation techniques applied to proteins (gel/capillary electrophoresis).
• Expertise in method development and validation.
• Good knowledge of protein chemistry.
• Strong and proven laboratory skills, autonomy in his/her work.
• Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external partners.
• Ability to author comprehensive and accurate procedures, protocols and reports.
• Ability to work in a matrix and customer-oriented environment.
• Understanding of regulatory requirements and of GMP, a plus.
• French is mandatory. Good written English level (oral a plus).