About this role
<p>Key Roles and Responsabilities:</p> <ul> <li>Formulation and Process Development of complex formulations under QbD principles;</li> <li>Compliance with GMP, ICH and other regulations in force and applicable to the development and validation of drug products;</li> <li>Resolution of Technical and scientific problems;</li> <li>Plan and perform experiments, investigations and evaluations;</li> <li>Scaling up for manufacturing of batches for pre-clinical and clinical trials;</li> <li>Comprehensive reporting and documentation of results and experiments including development protocols and reports, following the internal procedures and current documentation practices;</li> <li>Support for necessary quality documentation for regulatory submissions;</li> <li>Active collaboration in internal dissemination of knowledge (including providing training, preparing presentations, and participating in discussion forums).</li> </ul> <p>Requirements:</p> <ul> <li>Background in Chemistry, Pharmaceutical Sciences, Biophysics, Biochemistry or other related areas;</li> <li>A minimum of 2 years of experience and PhD is required;</li> <li>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,);</li> <li>Fluency in English (oral and written);</li> <li>Knowledge of statistical concepts;</li> <li>Good computer skills (Microsoft Word, Excel and PowerPoint as a minimum);</li> <li>Strong time management and organization skills;</li> <li>Communication skills to develop good working relationships and to work effectively in a team environment;</li> <li>Strong analytical and problem-solving skills;</li> <li>Close attention to details and high commitment to quality;</li> <li>Be proactive and critical.</li> </ul>