Formulation Scientist - 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.