Key Responsibilities

• Lead formulation development projects for solid oral dosage forms (tablets, capsules) and/or injectable dosage forms.
• Develop formulation strategies in line with global regulatory requirements.
• Oversee pre-formulation studies, formulation development, process optimization, and scale-up activities.
• Review and approve formulation strategies, experimental designs, and development reports.
• Troubleshoot formulation and manufacturing process issues.
• Support technology transfer to manufacturing sites, including scale-up, exhibit batches, and process validation.
• Prepare and review technical documentation for regulatory submissions.
• Respond to regulatory queries and support audits and inspections.
• Plan project timelines, allocate resources, and manage multiple development projects.
• Ensure timely project completion while maintaining high documentation standards.

Required Technical Skills

• Formulation development of oral solid dosage forms and/or injectables.
• Pre-formulation and compatibility studies.
• Process optimization and scale-up.
• Technology transfer.
• Regulatory documentation and compliance (global markets).
• Process validation and exhibit batch support.
• Troubleshooting formulation and manufacturing issues.