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
- Robust 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.