We are looking for a Research Associate Formulation R&D; (Sterile) with relevant experience in the development and execution of simple and complex sterile formulations, including injectables and ophthalmic products.
Key Responsibilities
- Develop and execute assigned projects for sterile formulations, including simple and complex injectables and ophthalmics.
- Identify project requirements and coordinate the indenting, receipt, consumption and monitoring of raw materials, packing materials and consumables.
- Ensure cleanliness, equipment verification and calibration status, along with timely resolution of identified issues.
- Prepare SOPs for recent equipment and procedures and review existing SOPs for mandatory revisions.
- Review and interpret scientific literature to support formulation development and project decisions.
- Conduct literature surveys, pharmaceutical equivalence and pre-formulation studies during product development.
- Plan and execute laboratory-scale batches and optimization batches for formulation development.
- Develop and optimize drug formulations using appropriate technology and scientific principles.
- Conduct and monitor quantitative and qualitative pre-formulation studies for sterile dosage forms.
- Execute scale-up and exhibit batches at the plant level.
- Support product development in compliance with GLP procedures and QbD principles.
- Conduct experiments, analyze data and provide scientific inputs for formulation development.
- Prepare and maintain development batch compilation, stability batch compilation and other relevant documentation.
- Prepare PDR, MFR, specifications, stability protocols, stability reports and other departmental documents.
- Execute technology transfer of finalized F&D; products to the manufacturing site along with complete documentation.
- Ensure development of sterile dosage forms in accordance with QTTP and applicable regulatory requirements.
- Perform any other responsibilities assigned by the HOD related to t
📌 Research Associate (Hyderabad)
🏢 Difgen Pharmaceuticals
📍 Hyderabad
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