Formulation Scientist (m/f)

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.