Formulation And Development Research Associate

Research Associate Formulation Development (F&D)

Location: Turbhe, Navi Mumbai, Maharashtra

Employment Type: Full-Time | On-site

Experience: 2–4 Years

Qualification: M. Pharm

Job Summary

We are looking for a Research Associate – Formulation Development (F&D) to join our pharmaceutical R&D team at Turbhe, Navi Mumbai.

The candidate will be responsible for formulation development activities across solid oral dosage forms and injectable products, including reference product characterization, prototype development, optimization, scale-up, stability monitoring, technology transfer documentation, and troubleshooting of commercial-scale batches.

Roles & Responsibilities

• Conduct literature and patent searches, review technical information, and support formulation development strategy.
• Support applications for Test Licenses, Import Licenses, NOCs, and other regulatory permissions as required.
• Perform reference product characterization and reverse engineering.
• Conduct reformulation studies and initiate prototype formulation development.
• Design and develop prototype formulations including:
• Tablets
• Capsules
• Pellets
• Injectable dosage forms
• Work on immediate-release and modified-release formulations intended for regulated markets such as the US and EU.
• Monitor stability studies and support the finalization of prototype formulations.
• Optimize formulation composition and process parameters using Quality by Design (QbD) principles.
• Manufacture lab-scale R&D batches and support scale-up to pilot and commercial/production levels.
• Prepare and maintain technology transfer and quality documentation, including:
• Bill of Materials (BOM)
• Master Formula Records (MFR)
• Stability Protocols
• API Specifications
• Finished Product Specifications
• Product Development Reports (PDR)
• Regulatory query responses
• Provide technical support and troubleshooting during commercial-scale manufacturing batches at the production site.