Contracting – Brabant Wallon
As an Analytical Development – Document Specialist, your mission is to write and review scientific documents related to the stability and comparability of products in clinical development, primarily in phase 3. The team works on both biological and chemical molecules across various therapeutic indications:
* Write stability and comparability protocols and reports.
* Analyze and review scientific data to identify potential outliers.
* Ensure data consistency and accuracy before submission to regulatory authorities.
* Collaborate with team members and external stakeholders.
* Contribute to the continuous improvement of documentation processes.
* Master's degree in Chemistry, Biochemistry, or a related field.
* Minimum of 3 years' experience in the pharmaceutical, biotechnology, or related industry.
* Excellent scientific writing skills in English.
* Knowledge of GMP (Good Manufacturing Practices) regulations.
* Proficiency in analytical techniques (HPLC, UPLC, etc.).
* Basic skills in applied statistics.
* Previous experience in stability or analytical validation (an asset).
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV, lena.palmeri@jeffersonwells.be
Biochemistry, UPLC, VOS, GMP, Chemistry, Science, Scientific Writing, GMP, Protocols, HPLC, Asset, Validation, Biotechnology, Science, Pharmaceuticals, Regulation, Applied statistics, Writing Skills