Senior 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 

• 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 

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)