Amit Sharma
Senior Formulation Scientist
- Role
- Senior Formulation Scientist at Adare Pharma Solutions
- Location
- Dayton, OH, US
- LinkedIn followers
- 500 followers
About Amit Sharma
Senior Formulation Scientist with over 10 years of experience in the design, development,…
Experience
Senior Formulation Scientist
May 2024 — Present · Philadelphia, PA, US
Led formulation and process development of oral solid dosage forms targeting Parkinson’s and Alzheimer’s disease, supporting Phase clinical trials and NDA readiness submissions.• Contributed to an NDA submission for an oral solid dosage form used in cancer treatment, providing support across formulation optimization from lab-scale development to scale-up, clinical trial manufacturing, and validation batch production.• Interacted directly with the client during project meetings, shared technical knowledge, presented clear data for discussion and provided input to support decision making, while keeping the project on schedule and meeting deadlines.• Conduct comprehensive literature and patent searches and characterize the materials for the project to support formulation strategies and process development.• Develop robust and scalable formulations using QbD principles for Phase I, II, and clinical trials.• Design and execute stability and compatibility studies to select optimal excipients and packaging systems.• Conducted risk assessment using the Fishbone (Ishikawa) method to analyze and address challenges encountered during scale-up of manufacturing processes for the project.• Analysed analytical data and draw meaningful conclusions to support continuous improvement of developmental and clinical trial manufacturing (CTM) batches.• Prepared technical formulation documents, including development and clinical trial batch records, protocols, stability protocols and evaluation reports for New Drug Applications (NDA) projects.• Ensure full GMP compliance throughout all formulation development and documentation activities.• Coordinated with vendors and clients to evaluate equipment and materials for the project, ensuring cost-effective solutions were considered for development and client requirements were promptly met.
Education
University of Mumbai
Bachelor's degree, Pharmacy
2008 — 2012
Long Island University
Master of Science - Industrial Pharmacy, Pharmaceutical Sciences
2018 — 2020
University of Mumbai
Masters, Quality Assurnace
2012 — 2014
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