CORE COMPETENCIES / TECHNICAL SKILL
• Preparation of literature search report with inclusion of project criticalities.
• Preparation of API and RLD requirement at the start of the project initiation.
• Conducting preliminary patent search.
• Selection of API source, excipients, tooling and packing materials.
• Performing innovator characterization.
• Preparation of formulation development strategy report based on the literature search and patent evaluation.
• Conducting Pre-formulation studies.
• Designing and executing the lab scale trials to achieve prototype by optimization of formula and process so as to achieve reproducibility of predetermined and/or finalized product specification.
• Finalizing stable formula with robust process.
• Initiation & review of stability studies as per guidelines & requirements.
• Critical evaluation of discriminatory/bio-relevant dissolution studies & bioequivalence studies.
• Preparation of relevant documents like Master Formula Card (MFC), Stability protocols, Product Development Report (PDR) in QbD format, Scale Up and Process Optimization Studies.
• Involving in Validation batches, Scale Up and Exhibit/Submission batches.
• Co-ordination with cross-functional team in smooth filing of regulatory Submissions.
• Addressing regulatory deficiencies/queries in stipulated timelines.
• Involved in preparation and finalization of SOP’s related to equipments and systems.
