23 Aug
|
Genvicure Therapeutics
|
Mumbai
23 Aug
Genvicure Therapeutics
Mumbai
Research Associate Formulation Development (F&D;)
Location: Turbhe, Navi Mumbai, Maharashtra
Employment Type: Full-Time | In office
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.
📌 Formulation And Development Research Associate (Mumbai)
🏢 Genvicure Therapeutics
📍 Mumbai