SACHIN SONAWANE

• Development of formulation for High Potent, ultra-low dose formulation in category of Anticancer, Hormone.
• Regulatory strategy finalization for new product.
• Prefomrulation studies and Formulation and process development and optimization
• Collaborated with cross-functional teams to achieve project goals on time and within budget.
• Working together with product portfolio identification team for molecule selection for development.
• Execution of scale up and regulatory filing batches.
• Document preparation like (PDR, scale up report) for filing of product.
• Regulatory Query response and product audit completion as per regulatory requirements.
• Followed all company policies and procedures to deliver quality work.
• Created and delivered presentations to internal and external stakeholders to showcase work.
• Earned recognition as top performer consistently exceeding targets throughout my tenure as specialist.
• Mentored team members, fostering professional growth through guidance on best practices in the industry.

Products filed till date: 5 products in China, 1 product filled in Brazil and 1 product filled in Canada and USA.

• Development of product with technology like wruste coating, Granulation (Fluid bed/wet/dry), Pelletisation by extrusion spherization, extended release, Effervescent, Chewable and Bi-layered Tablets.
• Worked on proton pump inhibitor, Anti-psychotic, anti-muscarinic, prostatic hyperplasia drug product formulation.
• Execution of scale up and regulatory filing batches.
• Document preparation like (PDR, scale up report) for filing product.

Products filed: 1 product filed in USA.

• Pre-formulation studies.
• Formulation and process development and optimization for Anti-hypertensive, Anti-retroviral formulation.
• Execution of scale up and regulatory filing batches.
• Document preparation like (PDR, scale up report) for filing of the product.
• Qualification and Calibration of equipment’s.
• Simultaneously managed several complex projects, meeting all pertinent milestones.
• Conducted experiments in laboratory environment for product development purposes.
• Documented changes during experiments, noting unexpected issues arising during research activities.

Products filed: 2 product Filed in PEFAR market, 2 products are filed in Europe.

• Offered technical support and troubleshot issues to enhance office productivity.
• Supported departmental tasks to increase understanding of industry processes.
• Completed industrial project on Design, Development and Evaluation of the Topical Foam Formulation.
• Completed projects and work assignments within strict time constraints.