Senior R&D Manager

Employment: Full-time Experience: Mid-Senior level Education: Master's Degree 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)