Senior R&D Manager
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Before you apply
LocationGiza, El Omraniya, Egypt
Work modeon-site
Typefull-time
SenioritySenior
Experience10–15 yrs
DepartmentR&D Business Division
Company size1,001–5,000 people
PostedJun 4, 2026 · 5mo ago
Verified live15h ago
May no longer be actively hiring
Posted by the company on Jun 4, 202673% of this company's open roles have been listed for 90+ days
At a glanceSummarised by Seekless from the posting.
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
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)
Skills
HPLC
UPLC
ICH Q2(R1)
ICH Q3A
ICH Q3B
ICH Q1A
ICH Q1B
ICH Q1C
ICH Q1D
ICH Q1E
ICH Q1F
Ph. Eur.
USP
NGI
ACI
About the role
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
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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
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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
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Ensure complete, audit-ready transfer documentation
Regulatory & CMC Support
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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)