Job Opportunities API

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 discrepancies  Ensure complete, audit-ready transfer documentation  Regulatory & CMC Support  Contribute analytical sections to CTAs, MAAs, DMFs, and local dossiers  Prepare validation reports, specifications, and analytical justifications  Support regulatory queries and inspection readiness  Team Leadership & Mentorship  Lead and coordinate a team of 3–6 analysts: priorities, workload, and delivery tracking  Coach analysts through technical challenges, troubleshooting, and data interpretation  Conduct regular feedback sessions and support individual development plans  Foster scientific discipline, accuracy, and continuous improvement  Requirements Education: Master's or PhD in Pharmaceutical Sciences, Analytical Chemistry, or related field  Overall Experience:  10–15 years in pharmaceutical analytical development (R&D environment), 2–3 years leading or coordinating a small analytical team or project group  Technical skills:  HPLC/UPLC method development and validation — minimum 6–8 years hands-on  Impurity profiling, forced degradation, and stability studies per ICH guidelines  Dissolution method development for solid, semi-solid (Gel), and transdermal (Patch) dosage forms  Gel and Patch characterisation: release rate, rheology, adhesion, permeation  Peptide or DPI analytical characterisation  Analytical method transfer to QC with formal transfer protocols  Contribution to at least one regulatory dossier (CTA, MAA, or local registration)