Formulation Scientist (m/f) - Oral Solids

Key Roles and Responsabilities: Formulation and Process Development of complex formulations under QbD principles; Compliance with GMP, ICH and other regulations in force and applicable to the development and validation of drug products; Resolution of Technical and scientific problems; Plan and perform experiments, investigations and evaluations; Scaling up for manufacturing of batches for pre-clinical and clinical trials; Comprehensive reporting and documentation of results and experiments including development protocols and reports, following the internal procedures and current documentation practices; Support for necessary quality documentation for regulatory submissions; Active collaboration in internal dissemination of knowledge (including providing training, preparing presentations, and participating in discussion forums). Requirements: Background in Chemistry, Pharmaceutical Sciences, Biophysics, Biochemistry or other related areas; A minimum of 2 years of experience and PhD is required; Knowledge of analytical techniques, namely principles and results interpretation, such as TLC, HPLC, GC-FID, HS-GC/FID, GC-MS, HS-GC/MS; LC-MS; HPLC-ELS, spectrophotometric techniques ( e.g., FTIR, UV), classical chemistry techniques (e.g., water content) and particle and solid-state characterization techniques (microscopy, particle size determination, X-ray diffraction, etc,); Fluency in English (oral and written); Knowledge of statistical concepts; Good computer skills (Microsoft Word, Excel and PowerPoint as a minimum); Strong time management and organization skills; Communication skills to develop good working relationships and to work effectively in a team environment; Strong analytical and problem-solving skills; Close attention to details and high commitment to quality; Be proactive and critical.