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Open nowPosted 122 days ago

Senior R&D Scientist - Solid Dosage Development

Workable (global search)107,990 open roles

Where
Giza, El Omraniya, Egypt
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Your applicationOpen nowSenior R&D Scientist - Solid Dosage DevelopmentWorkable (global search) · Giza, El Omraniya, Egypt

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This job: posted 122 days ago

Workable (global search) median: 6 days open

The posting

EVA Pharma is hiring Senior scientist to lead the design, development, optimisation, and scale-up of Fixed Dose Combination (FDC) generic products in tablet and capsule forms. The role should demonstrate deep expertise in multi-API formulation science, compatibility assessment, and dissolution development.

Main responsibilities:

Formulation Design & Optimisation

  • Design and develop FDC tablet and capsule formulations combining two or more APIs
  • Conduct preformulation: solubility, compatibility, polymorphism, and hygroscopicity for each API and the combination
  • Select excipients and platforms — IR, MR, bilayer, multi-particulate — based on TPP
  • Optimise formulations using QbD, DoE, and FMEA

Compatibility & Stability

  • Execute drug-drug and drug-excipient compatibility and forced degradation studies
  • Design and run ICH stability protocols; interpret data and propose formulation adjustments

Dissolution Development

  • Develop and validate discriminatory dissolution methods for each API in the FDC
  • Select biorelevant media and apparatus; investigate and resolve dissolution failures

Process Development & Scale-Up

  • Develop manufacturing processes — wet/dry granulation, direct compression, encapsulation — suited to FDC requirements
  • Define CPPs and CQAs; execute scale-up and process validation from lab to pilot to commercial

Tech Transfer

  • Prepare tech transfer packages: formulation dossier, batch records, process descriptions, in-process specs
  • Support on-site transfer, resolve deviations, and ensure reproducible handover to manufacturing

BE Support

  • Contribute to BE protocol design and formulation rationale for generic FDC versus reference innovator
  • Support interpretation of BE outcomes and propose reformulation where needed

Scientific Guidance

  • Provide day-to-day technical guidance to 1–3 junior scientists
  • Review data, troubleshoot failures, and maintain up-to-date knowledge of FDC science and compendial updates

Requirements

Education:

Master's or PhD in Pharmaceutical Sciences, Pharmaceutics, or related field

Experience:

8–10 years hands-on solid dosage formulation development in pharma industry

Technical skills:

  • FDC formulation experience — tablets and/or capsules — combining two or more APIs
  • Reformulations: solubility, compatibility, polymorphism, and stability assessment
  • Dissolution method development and validation for multi-API systems
  • Process development across wet/dry granulation, direct compression, and encapsulation
  • Scale-up and tech transfer to pilot and commercial manufacturing
  • BE protocol contribution for generic FDC products
  • QbD, DoE, and FMEA application in formulation development
  • Working knowledge of ICH Q1, Q6, Q8, Q9, Q10
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