Formulation And Development Research Associate

Genvicure Therapeutics; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Genvicure Therapeutics in Navi Mumbai seeks a Research Associate - Formulation Development (F&D) to advance solid oral dosage and injectable formulations. You will participate in prototype development, stability work, and technology transfer for regulatory filing.

The role requires 2-4 years of relevant experience and an M. Pharm. You will contribute to QbD-driven formulation optimization and collaborate with cross-functional teams in a fast-paced pharmaceutical R&D environment.

Qualifications

• Bachelor-level required: M. Pharm (Master of Pharmacy) or equivalent.
• 2-4 years of hands-on experience in formulation development.
• Experience with solid oral dosage forms and injectable products is preferred.
• Familiarity with regulatory documentation and tech transfer processes.

Responsibilities

• Conduct literature and patent searches to inform formulation strategy.
• Support applications for licenses, imports, NOCs and other regulatory permissions.
• Perform reference product characterization and reverse engineering.
• Conduct reformulation studies and initiate prototype formulation development.
• Design and develop prototype formulations including tablets, capsules, pellets, and injectables.
• Work on immediate-release and modified-release formulations for regulated markets (US/EU).
• Monitor stability studies and finalize prototype formulations.
• Optimize formulation composition and process parameters using QbD principles.
• Manage lab-scale R&D batches and support scale-up to pilot/production levels.
• Prepare and maintain technology transfer documentation (BOM, MFR, stability protocols, specifications).
• Provide technical support during commercial-scale manufacturing batches.

Skills

Literature searches

Patent searches

Formulation development

Scale-up

Documentation

Education

M. Pharm

Job description

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.