Senior R&D Scientist - Solid Dosage Development

About the role

Eva Pharma is hiring a Senior R&D Scientist to lead the design, development, optimisation and scale-up of Fixed Dose Combination (FDC) generic products in tablet and capsule forms. The role requires deep expertise in multi-API formulation science, compatibility assessment and dissolution development.

Key responsibilities

• Design and develop FDC tablet and capsule formulations combining two or more APIs, including preformulation of solubility, compatibility, polymorphism and hygroscopicity
• Select excipients and platforms (IR, MR, bilayer, multi-particulate) based on therapeutic product profile, and optimise formulations using QbD, DoE and FMEA
• Run drug-drug and drug-excipient compatibility and forced degradation studies, and design and run ICH stability protocols
• Develop and validate discriminatory dissolution methods, select biorelevant media and apparatus, and resolve dissolution failures
• Develop manufacturing processes such as wet/dry granulation, direct compression and encapsulation, define CPPs and CQAs, and scale up and validate from lab to pilot to commercial
• Prepare tech transfer packages and support on-site transfer, resolving deviations and ensuring reproducible handover to manufacturing
• Contribute to BE protocol design and formulation rationale, and interpret BE outcomes and propose reformulation where needed
• Provide day-to-day technical guidance to 1-3 junior scientists and keep up to date with FDC science and compendial updates

Required profile

• Master's or PhD in Pharmaceutical Sciences, Pharmaceutics or a related field
• 8-10 years of hands-on solid dosage formulation development in the pharmaceutical industry

Required skills

• FDC formulation experience for tablets and/or capsules combining two or more APIs
• Dissolution method development and validation for multi-API systems
• Process development across wet/dry granulation, direct compression and encapsulation, and scale-up and tech transfer
• Application of QbD, DoE and FMEA in formulation development
• Working knowledge of ICH Q1, Q6, Q8, Q9 and Q10