Job Opportunities API

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