Senior R&D Manager

Responsibilities

• Drive analytical method development and optimization for HPLC/UPLC and dissolution across various dosage forms including Solids, Peptides, DPI, Gels, and Patches
• Execute full ICH Q2(R1) method validation and author comprehensive validation reports
• Lead physicochemical characterization, impurity profiling, and forced degradation studies per ICH guidelines
• Design and execute stability protocols (ICH Q1A–Q1F) and author shelf-life justifications for regulatory submissions
• Manage the technical transfer of methods from R&D to QC, including training analysts and resolving discrepancies
• Contribute analytical sections to regulatory dossiers such as CTAs, MAAs, and DMFs
• Lead and mentor a team of 3–6 analysts, managing workloads, priorities, and professional development

Requirements

• Master's or PhD in Pharmaceutical Sciences, Analytical Chemistry, or a related field
• 10–15 years of experience in pharmaceutical analytical development within an R&D environment
• 2–3 years of experience in team leadership or project coordination
• 6–8 years of hands-on experience in HPLC/UPLC method development and validation
• Proven expertise in impurity profiling, stability studies, and dissolution method development
• Experience with Gel and Patch characterization (rheology, adhesion, permeation) or Peptide/DPI analytical characterization
• Demonstrated experience contributing to regulatory dossiers (CTA, MAA, or local registration)

About the Company

EVA Pharma is a leading pharmaceutical company dedicated to developing and delivering high-quality healthcare solutions. We focus on innovation and excellence across various therapeutic areas to improve patient lives globally.