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Open nowPosted 122 days ago

Senior R&D Manager

Workable (global search)108,016 open roles

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Giza, El Omraniya, Egypt
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Your applicationOpen nowSenior R&D ManagerWorkable (global search) · Giza, El Omraniya, Egypt
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This job: posted 122 days ago

Workable (global search) median: 7 days open

The posting

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)
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