Senior R&D Manager
Eva Pharma · Giza
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
Requirements
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)