Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

YOUR RESPONSIBILITIES

  • Manage stability program for market products
  • Contribute to and review stability protocols
  • Establish trending sheets/rules and statistical analysis for stability and release data
  • Keep overview on assay performance trending sheets
  • Maintain documentation for stability samples and trending
  • Serve as QC point of contact for installation of stability and trending software, including drafting of design and user requirements, oversee and support execution of software validation and implementation
  • Responsible for placing samples on stability, pulling samples, ensuring completion of testing, recording tracking and trending of test results
  • Initiating and completing deviations, CAPAs, OOS, OOC, laboratory investigations, and Change Controls as needed
  • Perform testing as needed
  • Strong knowledge of cGMP, Quality systems, and ICH / regulatory guidance

YOUR QUALIFICATIONS

  • Bachelor, Master Degree or equivalent in a relevant field (e.g. Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology)
  • Experience with setting up and coordinating stability studies
  • Experience with trending of results
  • Experience with statistical analysis of data
  • Knowledge of relevant guidelines
  • Experience with deviations, changes and preparation of reports
  • Background knowledge on assays performed for stability studies
  • Team work and excellent organizational skills
  • Fluent in English (oral and written), fluent in German

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 40.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

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