About the role

Responsibilities

Design and develop FDC tablet and capsule formulations combining two or more APIs
Conduct preformulation studies including solubility, compatibility, polymorphism, and hygroscopicity
Optimise formulations using QbD, DoE, and FMEA
Execute drug-drug and drug-excipient compatibility and forced degradation studies
Design and run ICH stability protocols
Develop and validate discriminatory dissolution methods for each API in the FDC
Develop manufacturing processes including wet/dry granulation, direct compression, and encapsulation
Define CPPs and CQAs and execute scale-up from lab to commercial manufacturing
Prepare tech transfer packages including formulation dossiers and batch records
Contribute to BE protocol design and formulation rationale
Provide technical guidance to junior scientists

Requirements

Master's or PhD in Pharmaceutical Sciences, Pharmaceutics, or related field
8–10 years hands-on solid dosage formulation development in pharma industry
Experience with FDC formulation (tablets and/or capsules)
Expertise in dissolution method development and validation for multi-API systems
Proficiency in QbD, DoE, and FMEA application
Working knowledge of ICH Q1, Q6, Q8, Q9, Q10