SeniorR&DManager

EVA Pharma is hiring Analytical Expert within R&D Analytical Development. The role drives analytical method development, characterisation, validation, stability, and technology transfer across small molecules, Peptides, DPI, Gels, and Patches — while coaching and coordinating a team of analysts. **Key responsibiities:** **Method Development & Validation** * Develop and optimise HPLC/UPLC and dissolution methods for DS and DP across Solids, Steriles, Peptides, DPI, Gels, and Patches * Execute full ICH Q2(R1) method validation: specificity, linearity, accuracy, precision, robustness, LOD/LOQ * Author validation reports and maintain lifecycle documentation **Characterisation & Impurity Profiling ** * Lead physicochemical and solid-state characterisation of DS and DP * Conduct impurity profiling and forced degradation studies per ICH Q3A/Q3B * Characterise Gel and Patch products: rheology, release rate, drug migration, adhesion, and skin permeation * Profile Peptide APIs: identity, purity, aggregation, and sequence confirmation * Support DPI characterisation: APSD via NGI/ACI, fine particle fraction, and blend uniformity **Bioassay Support ** * Support development and qualification of bioassay methods for potency and biological activity * Review and interpret bioassay data for batch release and stability **Stability Studies ** * Design and execute stability protocols per ICH Q1A–Q1F for DS and DP * Manage sampling plans, testing schedules, and data interpretation * Author shelf-life justification and stability summary reports for regulatory submissions **Dissolution Method Development ** * Develop biorelevant dissolution methods for solid, semi-solid (Gels), and transdermal (Patch) dosage forms * Validate dissolution methods and establish acceptance criteria per ICH/Ph. Eur./USP **Tech Transfer to QC ** * Lead method transfer from R&D to QC: protocols, acceptance criteria, and inter-lab comparison * Train QC analysts on transferred methods and resolve technical discrepa