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
