Senior R&D Analyst - Analytical Development

About the role

Eva Pharma is hiring an Analytical Expert within its R&D Analytical Development function. The role covers 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 responsibilities

• Develop and validate HPLC/UPLC and dissolution methods for solid, sterile, peptide, DPI, gel and patch products, including ICH Q2(R1) validation and lifecycle documentation
• Lead physicochemical and solid-state characterisation, impurity profiling and forced degradation (ICH Q3A/Q3B)
• Characterise gels and patches (rheology, release rate, adhesion, permeation) and peptide APIs (identity, purity, aggregation, sequence)
• Support DPI characterisation (APSD via NGI/ACI, fine particle fraction, blend uniformity) and bioassay development and review
• Design stability protocols (ICH Q1A-Q1F), manage sampling plans and author shelf-life justifications
• Lead method transfer from R&D to QC, train QC analysts and ensure audit-ready documentation
• Contribute analytical sections to CTAs, MAAs and DMFs, prepare validation reports and specifications, and support regulatory queries and inspections
• Lead and mentor a team of 3-6 analysts, tracking priorities, workload and delivery

Required profile

• Master's or PhD in Pharmaceutical Sciences, Analytical Chemistry or a related field
• 10-15 years in pharmaceutical analytical development (R&D environment)
• 2-3 years leading or coordinating a small analytical team or project group

Required 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 and transdermal dosage forms
• Gel and patch characterisation, peptide or DPI analytical characterisation
• Analytical method transfer to QC with formal protocols
• Experience contributing to at least one regulatory dossier (CTA, MAA or local registration)