Senior R&D Manager

Responsibilities

• Develop and optimise HPLC/UPLC and dissolution methods for DS and DP across various dosage forms
• Execute full ICH Q2(R1) method validation including specificity, linearity, and accuracy
• Lead physicochemical and solid-state characterisation of DS and DP
• Conduct impurity profiling and forced degradation studies per ICH Q3A/Q3B
• Design and execute stability protocols per ICH Q1A–Q1F
• Lead method transfer from R&D to QC including protocols and training
• Contribute analytical sections to CTAs, MAAs, DMFs, and local dossiers
• Lead and coordinate a team of 3–6 analysts, providing coaching and workload management

Requirements

• Master's or PhD in Pharmaceutical Sciences, Analytical Chemistry, or 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
• 6–8 years hands-on experience in HPLC/UPLC method development and validation
• Expertise in impurity profiling, forced degradation, and stability studies per ICH guidelines
• Experience with dissolution method development for solid, semi-solid, and transdermal dosage forms
• Experience with analytical method transfer to QC
• Proven contribution to regulatory dossiers (CTA, MAA, or local registration)

About the Company

EVA Pharma is a leading pharmaceutical company focused on developing and manufacturing high-quality healthcare solutions.