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)