R&D Formulation Manager

Key Responsibilities

Formulation Design & Optimization: Lead the development of robust pharmaceutical dosage forms (Oral Solids, Liquids, Topicals, or Sterile Injectables). Apply Quality by Design (QbD) principles and execute Design of Experiments (DoE) to optimize formulation parameters and process steps.

Pre-formulation & Compatibility Studies: Oversee critical physical and chemical characterizations, including API-excipient compatibility studies, solubility enhancement, and solid-state characterization.

• ✓ Technology Transfer: Manage the seamless scale-up and technology transfer of developed formulations from lab-scale to pilot plant and final commercial manufacturing sites. Troubleshoot scale-up issues directly on the production floor.
• ✓ Regulatory Dossier Support: Direct the compilation of technical documentation required for regulatory filings, including Product Development Reports (PDR), master formula records, and stability data protocols matching CTD/eCTD formats.
• ✓ Stability Testing Supervision: Oversee formulation stability trials according to ICH guidelines to determine product shelf-life and evaluate degradation pathways under accelerated and long-term conditions.

Team & Lab Management: Lead, mentor, and evaluate a dedicated team of F&D scientists and research associates. Ensure strict laboratory safety compliance, chemical inventory tracking, and calibration of R&D equipment.