Executive - Formulation Development

Role & responsibilities

• Prepare/review PDRs and pharmaceutical development reports
• Compile pre-formulation, formulation and process-development data
• Document formulation optimization and development rationale
• Prepare/review QbD, QTPP, CQA, CMA, CPP and risk-assessment documentation
• Prepare/review MFR, BMR and Technology Transfer documents
• Prepare scale-up, optimization and technical reports
• Support CTD/Module 3 pharmaceutical development documentation
• Review formulation, analytical and stability data for technical reports
• Prepare scientific justifications and regulatory query responses
• Ensure traceability from experimental data observations conclusions development decisions
• Check consistency across development reports, manufacturing documents and regulatory documentation
• Coordinate with F&D, ADL, QA, RA, Project Management and Manufacturing
• Ensure timely completion and lifecycle management of R&D technical documentation

Preferred candidate profile

• Strong Formulation R&D fundamentals
• Excellent scientific writing and technical interpretation
• Knowledge of QbD and risk-based pharmaceutical development
• Understanding of scale-up and technology transfer
• Exposure to regulated-market documentation
• Strong data-review and critical-thinking ability
• Excellent attention to detail and document ownership
• Proficiency in MS Word, Excel and PowerPoint