Research Associate - Formulation R&D (Sterile)

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 new 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 the concerned area.

Required Skills

• Strong knowledge of Sterile Formulation Development.
• Hands-on experience in Injectables and/or Ophthalmic formulations.
• Experience in pre-formulation, formulation optimization, scale-up and exhibit batches.
• Knowledge of QbD, GLP and pharmaceutical development principles.
• Good documentation and scientific report-writing skills.
• Ability to interpret scientific literature and analyze formulation development data.
• Experience in technology transfer and preparation of development documentation.