Eva Pharma
Pharmaceutical
SeniorR&DManager
“Senior R&D Manager at Eva Pharma. Skills: Analytical method development, Method validation, Impurity profiling, Stability studies, Technology transfer. Develop and optimise HPLC/UPLC methods. Develop and optimise dissolution methods”
Industry & Context.
Troubleshooting; Data interpretation
What They're Looking For.
Must Have
Master's or PhD, 10–15 years in pharmaceutical analytical development, 2–3 years leading or coordinating a small analytical team, HPLC/UPLC method development and validation minimum 6–8 years, Impurity profiling, forced degradation, and stability studies, 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, Contribution to at least one regulatory dossier
Nice to Have
PhD in Pharmaceutical Sciences, PhD in Analytical Chemistry
What You'll Do.
Develop and optimise HPLC/UPLC methods
Develop and optimise dissolution methods
Execute ICH Q2(R1) method validation
Author validation reports
Maintain lifecycle documentation
Lead physicochemical characterisation
Lead solid-state characterisation
Conduct impurity profiling
Conduct forced degradation studies
Characterise Gel products
Characterise Patch products
Support DPI characterisation
Support bioassay method development
Support bioassay method qualification
Interpret bioassay data
Design stability protocols
Execute stability protocols
Manage sampling plans
Manage testing schedules
Interpret stability data
Author shelf-life justification
Author stability summary reports
Develop biorelevant dissolution methods
Validate dissolution methods
Establish dissolution acceptance criteria
Lead method transfer to QC
Resolve technical discrepancies
Ensure audit-ready transfer documentation
Contribute analytical sections to dossiers
Prepare validation reports
Prepare specifications
Prepare analytical justifications
Support regulatory queries
Support inspection readiness
Lead and coordinate a team
Troubleshoot technical challenges
Conduct feedback sessions
Support development plans
Foster scientific discipline
Foster continuous improvement
How You'll Work.
Team & Collaboration
Coordinate a team; Train QC analysts; Collaborate with regulatory
Communication Scope
Technical documentation; Data interpretation
Process & Methodology
Workload tracking, Delivery tracking
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