A forward-thinking professional with extensive laboratory experience and a strong focus on quality assurance. Demonstrates expertise in risk evaluation, scientific literature reviewing, and new product planning. Adept at budgeting oversight, experimental design and execution, and regulatory compliance. Skilled in equipment maintenance, inventory management and familiar with industry-specific technology and regulatory standards. Committed to driving innovation in product development while ensuring adherence to regulatory requirements.
• Carryout new formulation development & existing Formulation.
• Initiate the feasibility study followed by a pre-formulation study.
• Preparation of recipe of new product for drug administration approval.
• Assessment and selection of raw and packaging material.
• Preparation of generic drug from Reference Listed Drug/Reference Standard for solid dosage drug products.
• Carryout Lab batch and Pilot batch Manufacturing.
• Preparation of SOP’s for product development equipment and activities.
• Conduct stability study.
• Preparation of tentative master formula as well as final master formula with necessary amendments and handover to production and QA for the preparation of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).
• Preparation of Optimization Protocol and Report.
• Preparation of Product Development Report (PDR).
• Carry out commercial batches for smooth production and for validation of manufacturing.
• Preparation of bio waiver request.
• Ensure compliance followed by GMP for equipments and documents.
• Ensure Cleanliness, Calibration and keeping record of R&D equipment/machines.
Successfully launched three essential medicines during COVID-19 (Favipiravir, Molnupiravir, Nrimatrelvir)