E

Eva Pharma

Produces affordable medicines for global access

Senior R&D Manager

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeGiza, El Omraniya, Giza Governorate, EgyptNo salary listedIn-person

About the Job

Requirements

  • A Master's or PhD in Pharmaceutical Sciences, Analytical Chemistry, or a related field.
  • 10–15 years of experience in pharmaceutical analytical development in an R&D environment, including 2–3 years leading or coordinating a small analytical team or project group.
  • At least 6–8 years of hands-on HPLC/UPLC method development and validation.
  • Experience with impurity profiling, forced degradation, and stability studies in accordance with ICH guidelines.
  • Experience developing dissolution methods for solid, semi-solid (gel), and transdermal (patch) dosage forms.
  • Experience characterising gels and patches, including release rate, rheology, adhesion, and permeation.
  • Experience with peptide or DPI analytical characterisation.
  • Experience transferring analytical methods to QC using formal transfer protocols.
  • Contribution to at least one regulatory dossier, such as a CTA, MAA, or local registration.

Responsibilities

  • Develop and optimise HPLC/UPLC and dissolution methods for drug substances and drug products across solid, sterile, peptide, DPI, gel, and patch products.
  • Execute full ICH Q2(R1) method validation, including specificity, linearity, accuracy, precision, robustness, and LOD/LOQ.
  • Author validation reports and maintain lifecycle documentation.
  • Lead physicochemical and solid-state characterisation of drug substances and drug products.
  • Conduct impurity profiling and forced degradation studies in accordance with ICH Q3A/Q3B.
  • Characterise gel and patch products, including rheology, release rate, drug migration, adhesion, and skin permeation.
  • Profile peptide APIs for identity, purity, aggregation, and sequence confirmation.
  • Support DPI characterisation, including APSD via NGI/ACI, fine particle fraction, and blend uniformity.
  • Support development and qualification of bioassay methods for potency and biological activity.
  • Review and interpret bioassay data for batch release and stability.
  • Design and execute stability protocols for drug substances and drug products in accordance with ICH Q1A–Q1F.
  • Manage sampling plans, testing schedules, and data interpretation.
  • Author shelf-life justification and stability summary reports for regulatory submissions.
  • Develop biorelevant dissolution methods for solid, semi-solid (gel), and transdermal (patch) dosage forms.
  • Validate dissolution methods and establish acceptance criteria in accordance with ICH, Ph. Eur., and USP.
  • Lead method transfer from R&D to QC, including protocols, acceptance criteria, and inter-laboratory comparison.
  • Train QC analysts on transferred methods and resolve technical discrepancies.
  • Ensure transfer documentation is complete and audit-ready.
  • Contribute analytical sections to CTAs, MAAs, DMFs, and local dossiers.
  • Prepare validation reports, specifications, and analytical justifications.
  • Support regulatory queries and inspection readiness.
  • Lead and coordinate a team of 3–6 analysts, including 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.

About the Company

Eva Pharma

Produces affordable medicines for global access

EVA Pharma develops and manufactures affordable medicines for global markets, focusing on 12 therapeutic areas such as anti-infectives, metabolic health, oncology, and pediatrics. It operates four manufacturing facilities with a 5,000-strong team and produces over one million healthcare products daily. The company runs two regional research centers that use AI-driven prediction and mRNA R&D to develop biological products and first-of-its-kind capabilities in the Middle East and Africa. EVA Pharma distributes its products to more than 60 countries and seeks to expand access to high-quality medicines worldwide. Its differentiation comes from its scale, regional R&D capabilities, and commitment to sustainable access, aiming to meet pressing, unmet disease needs with reliable supply.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Al Sharikat, Egypt
Founded
1997

Recently Posted Jobs

Explore more opportunities at Eva Pharma

See more jobs