SeniorR&DScientist-SolidDosageDevelopment

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