R&D Manager

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