Senior R&D Scientist - Solid Dosage Development

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 

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