Bolsista Doutor [Métodos de dissolução; Biopredição, Biofarmacotécnica] BIOLAB SANUS
Core
Develop and optimize dissolution methods for solid and semi-solid pharmaceutical forms, supporting formulation development and bioequivalence studies.
Role type
Senior Research Scientist (Pharmaceutical Analysis)
Builds
Dissolution testing protocols and analytical validation reports for drug products
Domain
Pharmaceutical industry, analytical chemistry, bioequivalence
Required skills
Dissolution method development and optimization, Analytical validation (ICH Q2), Root cause analysis for OOS/OOT, Regulatory documentation preparation, Statistical data analysis, HPLC/UPLC/UV-Vis techniques
Preferred skills
Bioequivalence and biowaiver studies (BCS), Dissolution modeling (IVIVC), GastroPlus software
Technologies
USP Apparatus I, II, III, IV, HPLC, UPLC, UV-Vis, GastroPlus
Responsibilities
Define dissolution test conditions (medium, pH, apparatus, rotation speed, volume, time), Plan and execute analytical validations, Conduct method transfers between laboratories, Investigate out-of-specification results, Prepare regulatory submissions documentation, Collaborate with formulation and quality teams
Seniority
Senior, hands-on IC
