Senior R&D Scientist - Solid Dosage Development

Responsibilities

• Lead the design, development, and optimization of Fixed Dose Combination (FDC) tablet and capsule formulations.
• Conduct preformulation studies including solubility, compatibility, polymorphism, and hygroscopicity assessments.
• Utilize QbD, DoE, and FMEA methodologies to optimize formulations and select appropriate excipients.
• Execute drug-drug and drug-excipient compatibility studies and manage ICH stability protocols.
• Develop and validate discriminatory dissolution methods for multi-API systems.
• Define CPPs and CQAs to manage process scale-up and tech transfer from lab to commercial manufacturing.
• Prepare comprehensive tech transfer packages, including formulation dossiers and batch records.
• Support Bioequivalence (BE) protocol design and interpret outcomes for generic FDC products.
• Provide technical guidance and mentorship to junior scientists.

Requirements

• Master's or PhD in Pharmaceutical Sciences, Pharmaceutics, or a related field.
• 8–10 years of hands-on experience in solid dosage formulation development within the pharmaceutical industry.
• Proven expertise in FDC formulation involving two or more APIs.
• Strong experience in dissolution method development and validation for multi-API systems.
• Proficiency in process development techniques such as wet/dry granulation, direct compression, and encapsulation.
• Demonstrated experience in scale-up and technology transfer to pilot and commercial scales.
• Deep understanding of ICH guidelines (Q1, Q6, Q8, Q9, Q10).
• Practical application of QbD, DoE, and FMEA in formulation development.

About the Company

Eva Pharma is a leading pharmaceutical company dedicated to providing high-quality, affordable healthcare solutions globally through innovation and excellence in R&D.