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
Description
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 & OptimisationDesign 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 failuresProcess 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